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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135069
• Other study ID #: RAM-01
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2010
• Last updated: October 15, 2014
• Start date: October 2009
• Est. completion date: April 2010

Study information

• Verified date: October 2014
• Source: Spear Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Not required

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 40 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Acne

Intervention

Drug:
• Tretinoin microsphere 0.1%
Treatment of acne vulgaris
• Brand Retin-A Micro tretinoin microsphere gel 0.1%
Treatment of acne vulgaris
• placebo microsphere gel
treatment of acne vulgaris

Locations

Country	Name	City	State
United States	Moore Clinical Research	Land O Lakes	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Spear Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Acne	Counting of acne lesions both inflammatory and non-inflammatory	12 weeks	Yes