A Study of DER 45-EV Gel to Treat Rosacea

Rosacea Clinical Trial

— SGTDER45EV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940992
• Other study ID #: SGT DER 45 EV 09
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2009
• Last updated: December 31, 2014
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: December 2014
• Source: Sol-Gel Technologies, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• DER 45 EV
Topical application to face for 12 weeks
• Vehicle
Topical application to face for 12 weeks

Locations

Country	Name	City	State
United States	Augusta Centre for Dermatology and Skin	Augusta	Georgia
United States	DermResearch, Inc	Austin	Texas
United States	J & S Studies, Inc	College Station	Texas
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Madison Skin and Research, Inc	Madison	Wisconsin
United States	Baumann Cosmetic & Research Institute	Miami	Florida
United States	FXM Research Corp	Miami	Florida
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Skin Search of Rochester, Inc	Rochester	New York
United States	Premier Clinical Research	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Sol-Gel Technologies, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator Global Assessment (IGA) Improvement From Baseline	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).	Baseline to Week 12 / end of treatment	No
Primary	Change in Inflammatory Lesion Counts From Baseline	The LS mean changes from Baseline in inflammatory lesion count at Week 12.	Baseline to Week 12 / end of treatment	No