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