Outline: A Double-Blind, Placebo-Controlled Clinical Efficacy Evaluation and of a Anti-Dandruff Shampoo
Objective: To determine if the use of a test material treats dandruff.
Subjects: 50: 2 cells of 25 qualified subjects
Timing: 1-week washout period
8-week test
Start test within 10 days of receipt of samples
Draft report submitted within 4 weeks after study completion
Quantity: 55 individual containers with enough products to last for 8 weeks of use, under instructions provided by the Sponsor
Methodology: Clinical assessment by a Board-Certified Dermatologist

A Board-Certified Dermatologist qualifies each subject according to a dandruff identification scale after a 1-week washout period during which only the use of baby shampoo was permitted. Those qualified are enrolled.

Subjects are randomly assigned into one of 2 groups: Treatment or Placebo. Subjects are given the product to use at home, instructions for use and a daily diary to record application times and any other safety-related comments.

After 2, 4, and 8 weeks of use, subjects return for follow-up evaluations by the Dermatologist. Results are statistically analyzed to determine if there are significant differences at each time interval compared with baseline and treatment groups.