Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 164 for:    acne AND Vehicle
Previous Study | Return to List | Next Study

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

Tracking Information
First Submitted Date  ICMJE March 13, 2015
First Posted Date  ICMJE March 31, 2015
Results First Submitted Date  ICMJE May 30, 2017
Results First Posted Date  ICMJE March 29, 2019
Last Update Posted Date March 29, 2019
Study Start Date  ICMJE March 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use. [ Time Frame: Baseline until 12 weeks ]
Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use.
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2015)
Inflammatory lesions [ Time Frame: 12 weeks ]
Number of inflammatory lesions (papules and pustules) with daily use of NAG compared with vehicle over 12-weeks of use.
Change History Complete list of historical versions of study NCT02404285 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
  • Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment. [ Time Frame: 12 weeks ]
    Percent Change in Number of Non-inflammatory lesions (open and closed comedones) were counted after 12 weeks of either Vehicle of NAG treatment
  • Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks. [ Time Frame: Baseline until 12 weeks ]
    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).
  • Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks. [ Time Frame: Baseline until 12 weeks ]
    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).
  • Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks. [ Time Frame: Baseline until 12 weeks ]
    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).
  • Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks. [ Time Frame: Baseline until 12 weeks ]
    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).
  • Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks. [ Time Frame: Baseline until 12 weeks ]
    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).
  • Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks. [ Time Frame: Baseline until 12 weeks ]
    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).
  • Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks. [ Time Frame: Baseline until 12 weeks ]
    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).
  • Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks. [ Time Frame: Baseline until 12 weeks ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2015)
  • Non-inflammatory lesions [ Time Frame: 12 weeks ]
    Number of non-inflammatory lesions with daily use of NAG compared with vehicle over 12-weeks of use.
  • Investigator Global Assessment [ Time Frame: 12 weeks ]
    IGA grade (0-5) with daily use of NAG compared with vehicle over 12-weeks of use.
  • Treatment Areas [ Time Frame: 12 weeks ]
    Erythema will be scored per below: Score Assessment Description 0 Absent None
    1. Mild Slight, barely perceptible
    2. Moderate Notable, distinct presence
    3. Severe Intense, marked presence
  • Treatment Areas [ Time Frame: 12 weeks ]
    Dryness will be scored per below: Score Assessment Description 0 Absent None
    1. Mild Slight, barely perceptible
    2. Moderate Notable, distinct presence
    3. Severe Intense, marked presence
  • Treatment Areas [ Time Frame: 12 weeks ]
    Burning or Stinging will be scored per below: Score Assessment Description 0 Absent None
    1. Mild Slight, barely perceptible
    2. Moderate Notable, distinct presence
    3. Severe Intense, marked presence
  • Treatment Areas [ Time Frame: 12 weeks ]
    Erosion will be scored per below: Score Assessment Description 0 Absent None
    1. Mild Slight, barely perceptible
    2. Moderate Notable, distinct presence
    3. Severe Intense, marked presence
  • Treatment Areas [ Time Frame: 12 weeks ]
    Edema will be scored per below: Score Assessment Description 0 Absent None
    1. Mild Slight, barely perceptible
    2. Moderate Notable, distinct presence
    3. Severe Intense, marked presence
  • Treatment Areas [ Time Frame: 12 weeks ]
    Pain will be scored per below: Score Assessment Description 0 Absent None
    1. Mild Slight, barely perceptible
    2. Moderate Notable, distinct presence
    3. Severe Intense, marked presence
  • Treatment Areas [ Time Frame: 12 weeks ]
    Itching will be scored per below: Score Assessment Description 0 Absent None
    1. Mild Slight, barely perceptible
    2. Moderate Notable, distinct presence
    3. Severe Intense, marked presence
  • Quality of Life assessed by patient-reported Acne Quality of Life questionnaires [ Time Frame: 12 weeks ]
    Subjects will complete the Acne-QoL form at each visit. 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. Domain scores are calculated by adding the item scores within each domain, with higher scores reflecting better QoL determination.
Current Other Pre-specified Outcome Measures
 (submitted: March 7, 2019)
  • Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks. [ Time Frame: Baseline until 12 weeks ]
    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.
  • Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks. [ Time Frame: Baseline until 12 weeks ]
    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
  • Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks. [ Time Frame: Baseline until 12 weeks ]
    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
  • Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks. [ Time Frame: Baseline until 12 weeks ]
    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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne
Official Title  ICMJE A Multi-center, Double-blind, Vehicle-controlled Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne
Brief Summary This is a 12 week, multi-site, double-blind, vehicle-controlled study in subjects with mild to moderate facial acne. Subjects will be randomized 1:1 to apply either topical NAG or vehicle gel daily. Subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.
Detailed Description

Sample Size: N= 60 completed subjects Male and female subjects 12 years or older diagnosed with mild to moderate inflammatory facial acne vulgaris.

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

  1. Lesion counts with photography
  2. Investigator Global Assessment
  3. Acne Quality of Life Questionnaire
  4. Treatment Area Assessment by Investigator

Subjects will discontinue all baseline topical acne treatments with a 2 week washout and/or all systemic acne treatments with a 3 week washout. All subjects will be provided open label Cetaphil facial cleanser and double-blind NAG or vehicle product.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: 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.
    Other Name: NAG
  • Drug: 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.
Study Arms  ICMJE
  • Placebo Comparator: Vehicle

    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
    Intervention: Drug: Vehicle
  • Active Comparator: NAG (Next Science Acne 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
    Intervention: Drug: Next Science Acne Gel
Publications * Bernhardt MJ, Myntti MF. Topical Treatment With an Agent Disruptive to <em>P. acnes</em> Biofilm Provides Positive Therapeutic Response: Results of a Randomized Clinical Trial. J Drugs Dermatol. 2016 Jun 1;15(6):677-83.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2015)
68
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2015)
72
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female ages 12 and above
  2. Has 10 or more inflammatory lesions on the face (papules and pustules) as determined by qualified examiner at Start of Treatment.
  3. In the area to be treated, has no significant facial dermatological conditions other than acne (as determined by the investigator) that would interfere with any study treatment or procedure
  4. Is willing and able to discontinue use of all baseline acne treatments for the duration of their trial participation
  5. Agrees to refrain from professional facial treatments during their trial participation.
  6. Agrees to avoid tanning booth use and minimize sun exposure during their trial participation.
  7. Is willing and able to follow instructions and procedures including attending scheduled study visits, which will require adequate transportation to the study site
  8. Is able to read, understand and sign the informed consent document and communicate with study staff and investigator. If the subject is a minor, the parent or documented legal guardian must meet these consent requirements and the subject must be able to understand, agree to, and sign the assent form.

Exclusion Criteria:

  1. Has more than 2 nodules/cystic acne lesions on the face
  2. Has a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients
  3. Has any history of skin malignancy
  4. Has significant facial hair that would interfere with evaluation of acne lesions or global assessment.
  5. Has used any systemic medications (including antibiotics, estrogens, retinoids) primarily for treatment of acne in the 21 days prior to randomization.
  6. Has used estrogens primarily as treatment for acne in the 21 days prior to randomization (estrogens prescribed for other reasons will be allowed if stable for at least 30 days prior to randomization).
  7. Has had any professional facial treatments in the 14 days prior to randomization.
  8. Has received any investigational treatment in the 30 days prior to randomization.
  9. Have any significant medical problems or other issues that would, in the investigator's judgment, affect their suitability for participation in this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02404285
Other Study ID Numbers  ICMJE CSP-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Next Science TM
Study Sponsor  ICMJE Next Science TM
Collaborators  ICMJE
  • Jacksonville Center For Clinical Research
  • St. Johns Center for Clinical Research
  • Fleming Island Center for Clinical Research
Investigators  ICMJE
Study Director: Susan Greco, MD Jacksonville Center For Clinical Research
Principal Investigator: Annabelle Matias, MD Fleming Island Center for Clinical Research
Principal Investigator: Lara Church, MD St John's Center for Clinical Research
PRS Account Next Science TM
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP