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

Primary Purpose

Rosacea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DER 45 EV
Vehicle
Sponsored by
Sol-Gel Technologies, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baumann Cosmetic & Research Institute
  • FXM Research Corp
  • Augusta Centre for Dermatology and Skin
  • Minnesota Clinical Study Center
  • Skin Search of Rochester, Inc
  • Tennessee Clinical Research Center
  • DermResearch, Inc
  • J & S Studies, Inc
  • Premier Clinical Research
  • Madison Skin and Research, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

DER 45 EV Gel, 1%

Vehicle

DER 45 EV Gel, 5%

Arm Description

DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks

Placebo Gel applied topically once a day for 12 weeks

DER 45 EV Gel, 5% applied topically once a day for 12 weeks

Outcomes

Primary Outcome Measures

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).
Change in Inflammatory Lesion Counts From Baseline
The LS mean changes from Baseline in inflammatory lesion count at Week 12.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2009
Last Updated
December 31, 2014
Sponsor
Sol-Gel Technologies, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00940992
Brief Title
A Study of DER 45-EV Gel to Treat Rosacea
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sol-Gel Technologies, Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DER 45 EV Gel, 1%
Arm Type
Experimental
Arm Description
DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Placebo Gel applied topically once a day for 12 weeks
Arm Title
DER 45 EV Gel, 5%
Arm Type
Experimental
Arm Description
DER 45 EV Gel, 5% applied topically once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
DER 45 EV
Intervention Description
Topical application to face for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Topical application to face for 12 weeks
Primary Outcome Measure Information:
Title
Investigator Global Assessment (IGA) Improvement From Baseline
Description
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).
Time Frame
Baseline to Week 12 / end of treatment
Title
Change in Inflammatory Lesion Counts From Baseline
Description
The LS mean changes from Baseline in inflammatory lesion count at Week 12.
Time Frame
Baseline to Week 12 / end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofra Levy-Hacham, PhD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Baumann Cosmetic & Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
FXM Research Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Augusta Centre for Dermatology and Skin
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Skin Search of Rochester, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
DermResearch, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J & S Studies, Inc
City
College Station
State/Province
Texas
ZIP/Postal Code
77840
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Madison Skin and Research, Inc
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of DER 45-EV Gel to Treat Rosacea

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