Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% 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
- NCT01135069
- Run by
- Spear Pharmaceuticals
- People needed
- 480
- Starts
- 2009-10-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2014-10-27
Who can join
Age: 12 and older, up to 40. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Moore Clinical Research — Land O' Lakes, Florida, United States
Full record on ClinicalTrials.gov
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