Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Spear Pharmaceuticals
• Treatments: Tretinoin

Criteria

Inclusion Criteria:

• Normal, healthy male and female children and adult

• Written and verbal informed consent must be obtained. Patients age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent.

• Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study.

• Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.

• Considered reliable and capable of understanding their responsibility and role in the study.

Exclusion Criteria:

• Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.

• Abnormal pre-existing skin condition which might affect the normal course of acne vulgaris (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders).

• Use topical acne therapy during the two week period prior to study initiation.

• Use of systemic retinoid treatment within six months prior to study initiation.

• Pregnant or breast-feeding.

• Serious psychological illness.

• Participation in any clinical research study during the 30 day period preceding study initiation.