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

NCT ID: NCT01135069

Last Updated: 2014-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-04-30

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

Conditions

Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Generic

treatment of acne for 12 weeks

Group Type: ACTIVE_COMPARATOR

Tretinoin microsphere 0.1%

Intervention Type: DRUG

Treatment of acne vulgaris

Brand

Treatment of acne for 12 weeks

Group Type: ACTIVE_COMPARATOR

Brand Retin-A Micro tretinoin microsphere gel 0.1%

Intervention Type: DRUG

Treatment of acne vulgaris

Placebo

Treatment if acne for 12 weeks as placebo

Group Type: PLACEBO_COMPARATOR

placebo microsphere gel

Intervention Type: DRUG

treatment of acne vulgaris

Interventions

Tretinoin microsphere 0.1%

Treatment of acne vulgaris

Intervention Type: DRUG

Brand Retin-A Micro tretinoin microsphere gel 0.1%

Treatment of acne vulgaris

Intervention Type: DRUG

placebo microsphere gel

treatment of acne vulgaris

Intervention Type: DRUG

Other Intervention Names

Retin-A Micro

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spear Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Krunal Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Moore Clinical Research

Locations

Moore Clinical Research

Land O' Lakes, Florida, United States

Countries

United States

Other Identifiers

RAM-01

Identifier Type: -

Identifier Source: org_study_id