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

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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

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Next Science Acne Gel Drug: Vehicle Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
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
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.

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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).


Other Outcome Measures:
  1. 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.

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404285


Locations
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United States, Florida
Fleming Island Center for Clinical Research
Jacksonville, Florida, United States, 32203
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
St. Johns Center for Clinical Research
Ponte Vedra, Florida, United States, 32081
Sponsors and Collaborators
Next Science TM
Jacksonville Center For Clinical Research
St. Johns Center for Clinical Research
Fleming Island Center for Clinical Research
Investigators
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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

Publications of Results:
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Responsible Party: Next Science TM
ClinicalTrials.gov Identifier: NCT02404285     History of Changes
Other Study ID Numbers: CSP-003
First Posted: March 31, 2015    Key Record Dates
Results First Posted: March 29, 2019
Last Update Posted: March 29, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases