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

Study Overview
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Brief Summary
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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
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Not required

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

Conditions
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Acne

Intervention / Treatment
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* Drug: Tretinoin microsphere 0.1%
* Drug: Brand Retin-A Micro tretinoin microsphere gel 0.1%
* Drug: placebo microsphere gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Generic<br>treatment of acne for 12 weeks | Drug: Tretinoin microsphere 0.1%<br>* Treatment of acne vulgaris<br>|
| Active Comparator: Brand<br>Treatment of acne for 12 weeks | Drug: Brand Retin-A Micro tretinoin microsphere gel 0.1%<br>* Treatment of acne vulgaris<br>* Other names: Retin-A Micro;|
| Placebo Comparator: Placebo<br>Treatment if acne for 12 weeks as placebo | Drug: placebo microsphere gel<br>* treatment of acne vulgaris<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Acne | Counting of acne lesions both inflammatory and non-inflammatory | 12 weeks |