Conditions: Acne Vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 68
Healthy volunteers: no

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.

Arms:
arm 1: 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 arm 2: 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

Interventions: intervention 1: Next Science Acne Gel intervention 2: Vehicle
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: