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

A Pilot Study to Compare Tretinoin Gel, 0.05% to Tretinoin Gel Vehicle When Dosed Once or Twice Daily in Female Subjects With Classical Rosacea

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00621218

Enrollment

Registered

2008-02-22

Start date

2008-02-29

Completion date

2008-12-31

Last updated

2008-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea

Keywords

tretinoin, efficacy, safety, rosacea

Brief summary

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.

Interventions

DRUGtretinoin gel 0.05%

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

DRUGvehicle

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improvement in signs and symptoms of rosacea	16 weeks

Secondary

Measure	Time frame
Changes in various skin parameters	16 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026