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

NCT01135069 | Completed Phase 3 Results

• 1 other identifier: RAM-01
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• Improvement in Acne

  Counting of acne lesions both inflammatory and non-inflammatory

  12 weeks

Study Arms (3)

Generic

ACTIVE COMPARATOR

treatment of acne for 12 weeks

Drug: Tretinoin microsphere 0.1%

Brand

ACTIVE COMPARATOR

Treatment of acne for 12 weeks

Drug: Brand Retin-A Micro tretinoin microsphere gel 0.1%

Placebo

PLACEBO COMPARATOR

Treatment if acne for 12 weeks as placebo

Drug: placebo microsphere gel

Interventions

Tretinoin microsphere 0.1% DRUG

Treatment of acne vulgaris

Generic

Brand Retin-A Micro tretinoin microsphere gel 0.1% DRUG

Treatment of acne vulgaris

Also known as: Retin-A Micro

Brand

placebo microsphere gel DRUG

treatment of acne vulgaris

Placebo

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spear Pharmaceuticals: lead

Study Sites (1)

Moore Clinical Research

Land O' Lakes, Florida, 34628, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Limitations and Caveats

No unexpected problems.

Results Point of Contact

• Title: K.L. Spear M.D.
• Organization: Spear Pharma

spear@spearpharma.com

239-433-3442

Study Officials

• Krunal Patel, MD

  Moore Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 2, 2010
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 27, 2014
• Results First Posted: October 16, 2014

Record last verified: 2014-10

Locations

US (1)