A Study of DER 45-EV Gel to Treat Rosacea - Full Text View

A Study of DER 45-EV Gel to Treat Rosacea (SGTDER45EV)

This study is not yet open for participant recruitment.

Verified June 2011 by Sol-Gel Technologies, Ltd.

First Received on July 14, 2009. Last Updated on June 9, 2011 History of Changes

Sponsor:	Sol-Gel Technologies, Ltd.
Information provided by:	Sol-Gel Technologies, Ltd.
ClinicalTrials.gov Identifier:	NCT00940992

Purpose

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

Condition	Intervention	Phase
Rosacea	Drug: DER 45 EV Drug: Vehicle	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

U.S. FDA Resources

Further study details as provided by Sol-Gel Technologies, Ltd.:

Primary Outcome Measures:

Investigator Global Assessment improvement from baseline [ Time Frame: 12 weeks / end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in inflammatory lesion counts from baseline [ Time Frame: 12 weeks / end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	September 2011
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: DER 45 EV Gel, 1% DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks	Drug: DER 45 EV Topical application to face for 12 weeks
Placebo Comparator: Vehicle Placebo Gel applied topically once a day for 12 weeks	Drug: Vehicle Topical application to face for 12 weeks
Experimental: DER 45 EV Gel, 5% DER 45 EV Gel, 5% applied topically once a day for 12 weeks	Drug: DER 45 EV Topical application to face for 12 weeks

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940992

Contacts

Contact: Ofra Levy-Hacham, PhD

+972-8-9313433

Sponsors and Collaborators

Sol-Gel Technologies, Ltd.

More Information

No publications provided

Responsible Party:	Ofra Levy-Hacham, Ph.D., Sol-Gel Technologies, Ltd.
ClinicalTrials.gov Identifier:	NCT00940992 History of Changes
Other Study ID Numbers:	SGT DER 45 EV 09
Study First Received:	July 14, 2009
Last Updated:	June 9, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012