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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Sol-Gel Technologies, Ltd.
- Enrollment
- 92
- Locations
- 10
- Primary Endpoint
- Change in Inflammatory Lesion Counts From Baseline
Study Overview
Brief Summary
To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
DER 45 EV Gel, 1%
DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
Intervention: DER 45 EV (Drug)
Vehicle
Placebo Gel applied topically once a day for 12 weeks
Intervention: Vehicle (Drug)
DER 45 EV Gel, 5%
DER 45 EV Gel, 5% applied topically once a day for 12 weeks
Intervention: DER 45 EV (Drug)
Outcomes
Primary Outcomes
Change in Inflammatory Lesion Counts From Baseline
Time Frame: Baseline to Week 12 / end of treatment
The LS mean changes from Baseline in inflammatory lesion count at Week 12.
Investigator Global Assessment (IGA) Improvement From Baseline
Time Frame: Baseline to Week 12 / end of treatment
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).
Secondary Outcomes
No secondary outcomes reported