A Study of DER 45-EV Gel to Treat Rosacea

NCT ID: NCT00940992

Last Updated: 2015-01-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-01-31

Brief Summary

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

Detailed Description

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Conditions

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Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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DER 45 EV Gel, 1%

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

Group Type EXPERIMENTAL

DER 45 EV

Intervention Type DRUG

Topical application to face for 12 weeks

Vehicle

Placebo Gel applied topically once a day for 12 weeks

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Topical application to face for 12 weeks

DER 45 EV Gel, 5%

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

Group Type EXPERIMENTAL

DER 45 EV

Intervention Type DRUG

Topical application to face for 12 weeks

Interventions

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DER 45 EV

Topical application to face for 12 weeks

Intervention Type DRUG

Vehicle

Topical application to face for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sol-Gel Technologies, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ofra Levy-Hacham, PhD

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

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Baumann Cosmetic & Research Institute

Miami, Florida, United States

Site Status

FXM Research Corp

Miami, Florida, United States

Site Status

Augusta Centre for Dermatology and Skin

Augusta, Georgia, United States

Site Status

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Site Status

Skin Search of Rochester, Inc

Rochester, New York, United States

Site Status

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Site Status

DermResearch, Inc

Austin, Texas, United States

Site Status

J & S Studies, Inc

College Station, Texas, United States

Site Status

Premier Clinical Research

Spokane, Washington, United States

Site Status

Madison Skin and Research, Inc

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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SGT DER 45 EV 09

Identifier Type: -

Identifier Source: org_study_id

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