| Anti-Dandruff |
| 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 |
|
Procedures: |
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.
|