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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sol-Gel Technologies, Ltd.
ClinicalTrials.gov Identifier:
NCT00940992
First received: July 14, 2009
Last updated: February 14, 2013
Last verified: February 2013
  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 2

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:


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 ]

Enrollment: 92
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: September 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Locations
United States, Florida
Baumann Cosmetic & Research Institute
Miami, Florida, United States, 33140
FXM Research Corp
Miami, Florida, United States, 33175
United States, Georgia
Augusta Centre for Dermatology and Skin
Augusta, Georgia, United States, 30909
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New York
Skin Search of Rochester, Inc
Rochester, New York, United States, 14623
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
DermResearch, Inc
Austin, Texas, United States, 78759
J & S Studies, Inc
College Station, Texas, United States, 77840
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99204
United States, Wisconsin
Madison Skin and Research, Inc
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
Sol-Gel Technologies, Ltd.
Investigators
Study Director: Ofra Levy-Hacham, PhD Sponsor GmbH
  More Information

No publications provided

Responsible Party: 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: February 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014