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

Study Overview
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Brief Summary
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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
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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: Lesion counts with photography Investigator Global Assessment Acne Quality of Life Questionnaire 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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Next Science Acne Gel
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ages 12 and above Has 10 or more inflammatory lesions on the face (papules and pustules) as determined by qualified examiner at Start of Treatment. 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 Is willing and able to discontinue use of all baseline acne treatments for the duration of their trial participation Agrees to refrain from professional facial treatments during their trial participation. Agrees to avoid tanning booth use and minimize sun exposure during their trial participation. Is willing and able to follow instructions and procedures including attending scheduled study visits, which will require adequate transportation to the study site 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: Has more than 2 nodules/cystic acne lesions on the face Has a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients Has any history of skin malignancy Has significant facial hair that would interfere with evaluation of acne lesions or global assessment. Has used any systemic medications (including antibiotics, estrogens, retinoids) primarily for treatment of acne in the 21 days prior to randomization. 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). Has had any professional facial treatments in the 14 days prior to randomization. Has received any investigational treatment in the 30 days prior to randomization. Have any significant medical problems or other issues that would, in the investigator's judgment, affect their suitability for participation in this trial.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>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: Lesions will be counted and right, left and forward facing photographs will be taken Investigator Global Assessment Acne Quality of Life Questionnaire Treatment Area Assessment by Investigator | Drug: Vehicle<br>* 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.<br>|
| Active Comparator: NAG (Next Science Acne Gel)<br>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: Lesions will be counted and right, left and forward facing photographs will be taken Investigator Global Assessment Acne Quality of Life Questionnaire Treatment Area Assessment by Investigator | Drug: Next Science Acne Gel<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use. | Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use. | Baseline until 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment. | Percent Change in Number of Non-inflammatory lesions (open and closed comedones) were counted after 12 weeks of either Vehicle of NAG treatment | 12 weeks | 
| Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 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). | Baseline until 12 weeks | 
| Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 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). | Baseline until 12 weeks | 
| Change in Dryness With Daily Use of NAG Compared With Vehicle After 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). | Baseline until 12 weeks | 
| Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 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). | Baseline until 12 weeks | 
| Change in Erosion With Daily Use of NAG Compared With Vehicle After 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). | Baseline until 12 weeks | 
| Change in Edema With Daily Use of NAG Compared With Vehicle After 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). | Baseline until 12 weeks | 
| Change in Pain With Daily Use of NAG Compared With Vehicle After 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). | Baseline until 12 weeks | 
| Change in Itching With Daily Use of NAG Compared With Vehicle After 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). | Baseline until 12 weeks |