Overview

A Study of DER 45-EV Gel to Treat Rosacea

Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
0
Participant gender:
All
Summary
To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sol-Gel Technologies, Ltd.
Criteria
Inclusion Criteria:

- Males and females, 18 years of age or older

- Facial rosacea, with 12 or more inflammatory lesions (with no more than 2 nodules)

- Mild, Moderate or Severe (2, 3 or 4) rating of rosacea on the IGA

- Females of child-bearing potential must have negative urine pregnancy test result at
baseline and must be willing to use an effective form of contraception throughout the
study

Exclusion Criteria:

- Subjects who are pregnant, breast feeding, or planning a pregnancy during the study

- Allergy or sensitivity to ingredients in test product

- Any dermatological conditions of the face that may interfere with study evaluations

- Subjects unable to avoid or minimize exposure to factors that may exacerbate or
trigger rosacea