A 21 Day Pharmacokinetics Study in Papulopustular Rosacea
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | January 2014 |
A Phase 1, Open Label, Multiple Center Study to Evaluate the Pharmacokinetics of Once-Daily CLS001 Topical Gel Under Maximal Use Conditions Administered for 21 Days in Subjects With Papulopustular Rosacea
The purpose of this study is to characterize the pharmacokinetics of once daily topical gel
and confirm that steady state conditions are reached under maximal use conditions following
3 weeks of daily applications.
and confirm that steady state conditions are reached under maximal use conditions following
3 weeks of daily applications.
Inclusion Criteria:
- A diagnosis of papulopustular rosacea
- Grade 3 or 4 on the 5-point Investigator Global Assessment scale
- Presence of telangiectasia
Exclusion Criteria:
- steroid rosacea or subtype 3 (phymatous rosacea)
- clinically significant abnormal findings that would interfere with study objective or
risk to safety for the subject.
- nodular rosacea (lesions greater than 5mm with more than 2 modules)
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