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

Phase 3

Completed

• Conditions: Acne
• Interventions: Drug: placebo microsphere gel; Drug: Brand Retin-A Micro tretinoin microsphere gel 0.1%; Drug: Tretinoin microsphere 0.1%

• Registration Number: NCT01135069
• Lead Sponsor: Spear Pharmaceuticals

Brief 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.

Detailed Description

Not required

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Results First Submitted: 2013-05-28
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-09
• Last Update Submitted: 2014-10-15
• Results First Posted: 2014-10-16
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo microsphere gel	Treatment if acne for 12 weeks as placebo
Brand	Brand Retin-A Micro tretinoin microsphere gel 0.1%	Treatment of acne for 12 weeks
Generic	Tretinoin microsphere 0.1%	treatment of acne for 12 weeks

Primary Outcome Measures

Name	Time	Method
Improvement in Acne	12 weeks	Counting of acne lesions both inflammatory and non-inflammatory

Trial Locations

Locations (1)

Moore Clinical Research; 🇺🇸 Land O Lakes, Florida, United States