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Trial record 78 of 233 for:    acne AND Percent

A Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02404285
Recruitment Status : Completed
First Posted : March 31, 2015
Results First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Collaborators:
Jacksonville Center For Clinical Research
St. Johns Center for Clinical Research
Fleming Island Center for Clinical Research
Information provided by (Responsible Party):
Next Science TM

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Next Science Acne Gel
Drug: Vehicle
Enrollment 68
Recruitment Details  
Pre-assignment Details Subjects were enrolled in the study after signing informed consent and meeting inclusion/exclusion criteria per protocol. A Washout period of 2-3 weeks was initiated for subjects discontinuing topical acne or systemic acne treatment respectively to normalize by washing their face twice a day with the study facial cleansing soap.
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description

Subjects will be treated with once daily vehicle and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Subjects will be treated with once daily NAG and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Period Title: Overall Study
Started 33 35
Completed 31 33
Not Completed 2 2
Arm/Group Title Vehicle NAG (Next Science Acne Gel) Total
Hide Arm/Group Description

Subjects were treated with once daily vehicle and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:

  1. Lesions were counted and right, left and forward facing photographs were taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects were instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should was not to be applied around the eyes or near the mucous membranes. No other acne treatments was applied to the face during study participation.

Subjects were treated with once daily vehicle and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:

  1. Lesions were counted and right, left and forward facing photographs were taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects were instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should was not to be applied around the eyes or near the mucous membranes. No other acne treatments was applied to the face during study participation.

Total of all reporting groups
Overall Number of Baseline Participants 33 35 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 35 participants 68 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
 100.0%
35
 100.0%
68
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 35 participants 68 participants
Female
19
  57.6%
21
  60.0%
40
  58.8%
Male
14
  42.4%
14
  40.0%
28
  41.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 33 participants 35 participants 68 participants
33
 100.0%
35
 100.0%
68
 100.0%
1.Primary Outcome
Title Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use.
Hide Description Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use.
Time Frame Baseline until 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completes all visits.
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:

Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits:

1. Lesions were counted and right, left and forward facing photographs were taken

Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits:

1. Lesions were counted and right, left and forward facing photographs were taken

Overall Number of Participants Analyzed 33 35
Mean (Standard Error)
Unit of Measure: % change of inflammatory lesions count
-27  (12.5) -44  (8.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, NAG (Next Science Acne Gel)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment.
Hide Description Percent Change in Number of Non-inflammatory lesions (open and closed comedones) were counted after 12 weeks of either Vehicle of NAG treatment
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:

Subjects will be treated with once daily vehicle and the following were assessed at baseline, 2,4,8 and 12 week visits:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Subjects will be treated with once daily NAG and and the following was assessed at baseline, 2,4,8 and 12 week visits:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: % Change Non-inflammatory lesion count
-6.5  (7.1) -34.1  (5.8)
3.Secondary Outcome
Title Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks.
Hide Description Change in Investigator Global Assessment (IGA) score (0-5) with daily use of NAG compared with vehicle after 12-weeks. IGA score is worse at 5, with improvement at lower scores (best at 0).
Time Frame Baseline until 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:
Subjects were treated with once daily vehicle and attended baseline, 2,4,8 and 12 week visits and the number of non-inflammatory lesions were counted.
Subjects were treated with once daily NAG and attended baseline, 2,4,8 and 12 week visits and the number of non-inflammatory lesions were counted.
Overall Number of Participants Analyzed 33 35
Mean (Standard Error)
Unit of Measure: Score on a scale
Mean at Baseline 2.8  (.08) 2.4  (.09)
Mean after 12 Weeks 2.3  (0.13) 2.0  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, NAG (Next Science Acne Gel)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks.
Hide Description Change in Erythema (measure of redness) scores with daily use of NAG compared with vehicle after 12-weeks.Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame Baseline until 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Next Science Acne Gel had average erythema score decreasing from 0.5 to 0.3 for the Acne Gel and to 0.5 to 0.4 for the Vehicle Control (not shown).
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:
Subjects were treated with once daily vehicle and attended baseline, 2,4,8 and 12 week visits and the number of non-inflammatory lesions were counted.
Subjects were treated with once daily NAG and attended baseline, 2,4,8 and 12 week visits and the number of non-inflammatory lesions were counted.
Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Average Score on a scale
Mean at Baseline .5  (.8) .5  (.7)
Mean after 12 weeks 0.4  (0.8) 0.3  (0.5)
5.Secondary Outcome
Title Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks.
Hide Description Change in Dryness score with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame Baseline until 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
NAG application yielded Dryness average scores decreasing from 0.3 to 0.1 over 12 weeks compared to no decrease in the Vehicle control (0.3 to 0.3).
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:

Subjects will be treated with once daily vehicle and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Subjects will be treated with once daily NAG and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Average score on a scale
Mean at Baseline .3  (.5) .3  (.5)
Mean after 12 Weeks 0.3  (0.5) 0.1  (0.5)
6.Secondary Outcome
Title Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks.
Hide Description Change in Burning/Stinging scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame Baseline until 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
NAG application resulted in average Burning or Stinging scores increasing from 0.0 to 0.1 over 12 weeks, compared to a decrease in Vehicle Control from 0.1 to 0.0.
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:

Subjects will be treated with once daily vehicle and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Subjects will be treated with once daily NAG and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Average score on a scale
Mean at Baseline .1  (.3) 0  (0)
Mean after 12 Weeks 0  (0.3) 0.1  (0.3)
7.Secondary Outcome
Title Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks.
Hide Description Change in Erosion scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame Baseline until 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
NAG application resulted in average scores remaining between 0.1 and 0.0 for all time points for both NAG and Vehicle groups.
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:

Subjects will be treated with once daily vehicle and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Subjects will be treated with once daily NAG and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Average score on a scale
Mean at Baseline 0  (0) 0  (0)
Mean after 12 Weeks 0  (0.1) 0  (0.1)
8.Secondary Outcome
Title Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks.
Hide Description Change in Edema scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame Baseline until 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
NAG application resulted in average scores decreasing from 0.1 to 0.0 for the Acne Gel, and from 0.2 to 0.1 for the Vehicle Control.
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:

Subjects will be treated with once daily vehicle and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Subjects will be treated with once daily NAG and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Average score on a scale
Mean at Baseline .2  (.4) 0.1  (.3)
Mean after 12 Weeks 0.1  (0.4) 0  (0.3)
9.Secondary Outcome
Title Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks.
Hide Description Change in Pain scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame Baseline until 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
NAG and vehicle application yielded average pain scores decreasing from 0.1 to 0.0.
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:

Subjects will be treated with once daily vehicle and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Subjects will be treated with once daily NAG and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Average score on a scale
Mean at Baseline .1  (.2) .1  (.4)
Mean at 12 Weeks 0  (0.3) 0  (0.3)
10.Secondary Outcome
Title Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks.
Hide Description Change in Itching scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame Baseline until 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
NAG application resulted in Itching scores of 0.1 to 0.0 for the Acne Gel and from 0.2 to 0.0 for the Vehicle Control.
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:

Subjects will be treated with once daily vehicle and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Subjects will be treated with once daily NAG and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Average score on a scale
Mean at Baseline .2  (.5) .1  (.3)
Mean at 12 Weeks 0  (0.3) 0  (0.3)
11.Other Pre-specified Outcome
Title Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks.
Hide Description Change in Self Perception scores with daily use of NAG compared with vehicle after 12-weeks. The Acne Quality of Life (QoL) Questionnaire Form was used to determine the practical improvements in quality of life. The Acne-QoL form is a validated measure that contains 19 questions referring to the past week, organized into four area: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives.
Time Frame Baseline until 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The average self-perception score for NAG users increased from 4.1 to 5.0.
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:

Subjects will be treated with once daily vehicle and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Subjects will be treated with once daily NAG and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Mean at Baseline 3.5  (2.1) 4.1  (1.9)
Mean at 12 Weeks 4.6  (1.5) 5.0  (1.5)
12.Other Pre-specified Outcome
Title Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks.
Hide Description Change in Role-Emotional scores with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives
Time Frame Baseline until 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:

Subjects will be treated with once daily vehicle and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Subjects will be treated with once daily NAG and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Mean at Baseline 3.9  (1.6) 3.9  (1.8)
Mean at 12 Weeks 4.6  (1.4) 4.8  (1.3)
13.Other Pre-specified Outcome
Title Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks.
Hide Description Change in the subjects perception of their acne symptoms with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives
Time Frame Baseline until 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:

Subjects will be treated with once daily vehicle and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Subjects will be treated with once daily NAG and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Mean at Baseline 3.4  (1.1) 3.4  (1.2)
Mean at 12 Weeks 4.4  (1.3) 4.5  (1.1)
14.Other Pre-specified Outcome
Title Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks.
Hide Description Change in subjects social response to their acne with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives
Time Frame Baseline until 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The average Role-Social score increased from 4.5 to 5.3.
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description:

Subjects will be treated with once daily vehicle and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Subjects will be treated with once daily NAG and will attend baseline, 2,4,8 and 12 week visits. The following will be assessed:

  1. Lesions will be counted and right, left and forward facing photographs will be taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Mean at Baseline 4.1  (2.0) 4.5  (2.0)
Mean at 12 Weeks 4.7  (1.7) 5.3  (1.6)
Time Frame 12 Weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vehicle NAG (Next Science Acne Gel)
Hide Arm/Group Description

Subjects were treated with once daily vehicle and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:

  1. Lesions were counted and right, left and forward facing photographs were taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Vehicle: Subjects were instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry.

Subjects were treated with once daily NAG and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:

  1. Lesions were counted and right, left and forward facing photographs were taken
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Next Science Acne Gel: Subjects were instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry.

All-Cause Mortality
Vehicle NAG (Next Science Acne Gel)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)      0/35 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Vehicle NAG (Next Science Acne Gel)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/33 (0.00%)      0/35 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vehicle NAG (Next Science Acne Gel)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/33 (21.21%)      9/35 (25.71%)    
General disorders     
Gastritis   1/33 (3.03%)  1 0/35 (0.00%)  0
Vomiting  [1]  1/33 (3.03%)  1 0/35 (0.00%)  0
Headache   0/33 (0.00%)  0 1/35 (2.86%)  1
General aches   0/33 (0.00%)  0 1/35 (2.86%)  1
Mild celiac disease   0/33 (0.00%)  0 1/35 (2.86%)  1
Abdominal cramps   0/33 (0.00%)  0 1/35 (2.86%)  1
Fatigue   1/33 (3.03%)  1 0/35 (0.00%)  0
Infections and infestations     
Bronchitis   1/33 (3.03%)  1 0/35 (0.00%)  0
Haemtoma  [2]  1/33 (3.03%)  1 0/35 (0.00%)  0
Rhinitis   2/33 (6.06%)  2 0/35 (0.00%)  0
Urinary Tract Infection   0/33 (0.00%)  0 1/35 (2.86%)  1
Laryngitis   0/33 (0.00%)  0 1/35 (2.86%)  1
Cough   0/33 (0.00%)  0 1/35 (2.86%)  1
Upper Respiratory Infection   0/33 (0.00%)  0 1/35 (2.86%)  1
Otitis Media   0/33 (0.00%)  0 1/35 (2.86%)  1
Indicates events were collected by systematic assessment
[1]
Vomiting
[2]
Left Thumbnail Haematoma
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Matt Myntti PHD, President
Organization: Next Science
Phone: 9046474161
Responsible Party: Next Science TM
ClinicalTrials.gov Identifier: NCT02404285     History of Changes
Other Study ID Numbers: CSP-003
First Submitted: March 13, 2015
First Posted: March 31, 2015
Results First Submitted: May 30, 2017
Results First Posted: March 29, 2019
Last Update Posted: March 29, 2019