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A Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea

NCT ID: NCT00621218

Last Updated: 2008-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-12-31

Brief Summary

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To compare the efficacy and safety of tretinoin gel 0.05% to its vehicle when dosed once or twice daily in female subjects with rosacea.

Detailed Description

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Conditions

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Rosacea

Keywords

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tretinoin, efficacy, safety, rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

tretinoin gel 0.05%

Intervention Type DRUG

Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea

2

Group Type PLACEBO_COMPARATOR

vehicle

Intervention Type DRUG

Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.

Interventions

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tretinoin gel 0.05%

Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea

Intervention Type DRUG

vehicle

Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female
* Age 18-65
* Diagnosed with classical, centrofacial, erythemato-telangiectatic rosacea

Exclusion Criteria

* Male, females less than 18 years
* Females over 65 years
* No diagnosed rosacea
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Coria Laboratories, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Coria Laboratories, Ltd.

Principal Investigators

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Morris V Shelanski, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Product Investigations, Inc.

Conshohocken, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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9320-010-002

Identifier Type: -

Identifier Source: org_study_id