Outline: Clinical Evaluation To Determine the Comedogenic Potential of Skin Care Products
Objective: To determine the comedogenic potential of test materials.
Subjects: 15 qualified individuals prone to break-outs
Timing: 4 week test period
Start test within 10 days of receipt of test article
Report issued within 4 weeks after completion
Quantity: 8 oz. bulk

Follicular biopsies compared with positive and negative controls

Test materials, a positive control and a negative control are applied to occlusive patch units and placed on the back of each qualified subject. The patches are worn for 48 hours, when subjects return to the Testing Facility. The patches are removed, the sites are evaluated for irritation according to scale, and patches re-applied. This procedure takes place every Monday, Wednesday and Friday until 12 applications have taken place. After the 12th application patch is removed and the site scored, a follicular biopsy of each site is taken and evaluated for the presence of comedones. The biopsy scores are statistically analyzed (compared with the positive and negative controls).