Title
A Study of DER 45-EV Gel to Treat Rosacea
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Range Study of DER 45 EV Gel, 1% and 5%, and Vehicle Gel in the Treatment of Rosacea
Phase
Phase 2Lead Sponsor
Sol-Gel Technologies, Ltd.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
RosaceaIntervention/Treatment
benzoyl peroxide ...Study Participants
92To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.
Topical application to face for 12 weeks
Topical application to face for 12 weeks
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
| Event Type | Organ System | Event Term | DER 45 EV Gel, 1% | Vehicle | DER 45 EV Gel, 5% |
|---|
The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).
The LS mean changes from Baseline in inflammatory lesion count at Week 12.
