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

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.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Drug: Tretinoin microsphere 0.1%; Drug: Brand Retin-A Micro tretinoin microsphere gel 0.1%; Drug: placebo microsphere gel

Detailed Description

Not required

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Generic; treatment of acne for 12 weeks	Drug: Tretinoin microsphere 0.1%; Treatment of acne vulgaris
Active Comparator: Brand; Treatment of acne for 12 weeks	Drug: Brand Retin-A Micro tretinoin microsphere gel 0.1%; Treatment of acne vulgaris; Other Names: Retin-A Micro
Placebo Comparator: Placebo; Treatment if acne for 12 weeks as placebo	Drug: placebo microsphere gel; treatment of acne vulgaris

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Acne	Counting of acne lesions both inflammatory and non-inflammatory	12 weeks

Collaborators and Investigators

• Sponsor: Spear Pharmaceuticals
• Investigators: Principal Investigator: Krunal Patel, MD, Moore Clinical Research

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: June 1, 2010
• First Posted (Estimate): June 2, 2010

Study Record Updates

• Last Update Posted (Estimate): October 27, 2014
• Last Update Submitted That Met QC Criteria: October 15, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Dermatologic Agents; Keratolytic Agents; Tretinoin
• Other Study ID Numbers: RAM-01