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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00940992
Recruitment Status : Completed
First Posted : July 17, 2009
Results First Posted : January 9, 2015
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Rosacea Drug: DER 45 EV Drug: Vehicle Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : January 2012
Primary Completion Date : September 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Investigator Global Assessment (IGA) Improvement From Baseline [ Time Frame: 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).

  2. Change in Inflammatory Lesion Counts From Baseline [ Time Frame: Baseline to Week 12 / end of treatment ]
    The LS mean changes from Baseline in inflammatory lesion count at Week 12.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sol-Gel Technologies, Ltd.
ClinicalTrials.gov Identifier: NCT00940992     History of Changes
Other Study ID Numbers: SGT DER 45 EV 09
First Posted: July 17, 2009    Key Record Dates
Results First Posted: January 9, 2015
Last Update Posted: January 9, 2015
Last Verified: December 2014

Additional relevant MeSH terms:
Rosacea
Skin Diseases