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

Coria Laboratories

Status and phase: Completed; Phase 2

Conditions: Rosacea

Treatments: Drug: vehicle; Drug: tretinoin gel 0.05%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621218

9320-010-002

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: tretinoin gel 0.05%

2

Placebo Comparator group

Treatment:

Drug: vehicle