Status:
COMPLETED
A Study of DER 45-EV Gel to Treat Rosacea
Lead Sponsor:
Sol-Gel Technologies, Ltd.
Conditions:
Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00940992
Start Date
January 1 2012
End Date
January 1 2013
Last Update
January 9 2015
Active Locations (10)
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1
Baumann Cosmetic & Research Institute
Miami, Florida, United States, 33140
2
FXM Research Corp
Miami, Florida, United States, 33175
3
Augusta Centre for Dermatology and Skin
Augusta, Georgia, United States, 30909
4
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432