A Study of DER 45-EV Gel to Treat Rosacea

Phase 2

Completed

• Conditions: Rosacea
• Interventions: Drug: Vehicle; Drug: DER 45 EV

• Registration Number: NCT00940992
• Lead Sponsor: Sol-Gel Technologies, Ltd.

Brief Summary

To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Study Start: 2012-01
• Primary Completion: 2012-09
• Study Completion: 2013-01
• Status Verified: 2014-12
• Results First Submitted: 2014-12-18
• Results First Submitted QC: 2014-12-31
• Last Update Submitted: 2014-12-31
• Results First Posted: 2015-01-09
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Placebo Gel applied topically once a day for 12 weeks
DER 45 EV Gel, 1%	DER 45 EV	DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
DER 45 EV Gel, 5%	DER 45 EV	DER 45 EV Gel, 5% applied topically once a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in Inflammatory Lesion Counts From Baseline	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	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).

Trial Locations

Locations (10)

Baumann Cosmetic & Research Institute; 🇺🇸 Miami, Florida, United States

Augusta Centre for Dermatology and Skin; 🇺🇸 Augusta, Georgia, United States

FXM Research Corp; 🇺🇸 Miami, Florida, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

Skin Search of Rochester, Inc; 🇺🇸 Rochester, New York, United States

DermResearch, Inc; 🇺🇸 Austin, Texas, United States

J & S Studies, Inc; 🇺🇸 College Station, Texas, United States

Premier Clinical Research; 🇺🇸 Spokane, Washington, United States

Madison Skin and Research, Inc; 🇺🇸 Madison, Wisconsin, United States

Tennessee Clinical Research Center; 🇺🇸 Nashville, Tennessee, United States