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

Spear Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Acne

Treatments: Drug: Brand Retin-A Micro tretinoin microsphere gel 0.1%; Drug: Tretinoin microsphere 0.1%; Drug: placebo microsphere gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01135069

RAM-01

Details and patient eligibility

About

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.

Full description

Not required

Enrollment: 480 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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480 participants in 3 patient groups, including a placebo group

Generic

Active Comparator group

Description:

treatment of acne for 12 weeks

Treatment:

Drug: Tretinoin microsphere 0.1%

Brand

Active Comparator group

Description:

Treatment of acne for 12 weeks

Treatment:

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

Placebo

Placebo Comparator group

Description:

Treatment if acne for 12 weeks as placebo

Treatment:

Drug: placebo microsphere gel