Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo

Completed · Phase 3 · Has a placebo group

Conditions studied: Acne

In brief

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.

Key facts

Study ID

NCT01243450

Run by

Spear Pharmaceuticals

People needed

958

Starts

2009-10-01

Expected to finish

2010-10-01

Last updated by the study team

2020-01-03

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• A subject will be eligible to participate if they meet none of the following exclusion criteria:
• Subjects with active cystic acne as evidenced by more than 2 facial nodules.
• More than 40 papules and/or pustules (inflammatory lesions)
• More than 60 open and or closed comedones/milia (non-inflammatory lesions)
• Overall severity grade of less than 2 or greater than 4,
• History of allergy or hypersensitivity to tretinoin.
• Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease
• Use of systemic retinoid treatment within six months prior to study initiation.
• Oral contraceptives should not be started or changed within 3 months prior to study initiation or planned to change during the study.
• Pregnant or breast-feeding.
• Participation in a clinical study for acne within 4 months preceding study initiation.

Where it is running

• Cu-Tech, LLC — Mountain Lakes, New Jersey, United States

Full record on ClinicalTrials.gov

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