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

Condition(s) targeted: Acne

Intervention: Tretinoin microsphere 0.1% (Drug); Brand Retin-A Micro tretinoin microsphere gel 0.1% (Drug); placebo microsphere gel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Spear Pharmaceuticals

Official(s) and/or principal investigator(s):
Krunal Patel, MD, Principal Investigator, Affiliation: Moore Clinical Research

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Improvement in Acne

Detailed description: Not required

Minimum age: 12 Years. Maximum age: 40 Years. Gender(s): Both.

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.

Moore Clinical Research, Land O Lakes, Florida 34628, United States

Starting date: October 2009
Last updated: October 15, 2014