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

This study has been completed.
Sponsor:
Information provided by:
Spear Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01135069
First received: May 28, 2010
Last updated: May 14, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Acne
 Drug: Tretinoin microsphere 0.1%
Drug: tretinoin microsphere gel 0.1%
Drug: placebo microsphere gel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo

Resource links provided by NLM:

MedlinePlus related topics: Acne
Drug Information available for: Tretinoin
U.S. FDA Resources

Further study details as provided by Spear Pharmaceuticals:

Primary Outcome Measures:
  • Improvement in Acne [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 480
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Generic
Tretinoin Microsphere Gel 0.1%
 Drug: Tretinoin microsphere 0.1%
Tretinoin, topical, daily
Drug: tretinoin microsphere gel 0.1%
Tretinoin, topical, daily
Active Comparator: Brand
Retin-A Micro 0.1%
 Drug: Tretinoin microsphere 0.1%
Tretinoin, topical, daily
Drug: tretinoin microsphere gel 0.1%
Tretinoin, topical, daily
Placebo Comparator: Placebo
Microsphere Gel no active
 Drug: Tretinoin microsphere 0.1%
Tretinoin, topical, daily
Drug: placebo microsphere gel
placebo, topical. daily

  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Normal, healthy male and female children and adults.
  • Age 12 to 40 years.
  • 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:

  • More than 40 papules and/or pustules (inflammatory lesions)
  • More than 60 open and or closed comedones/milia (non-inflammatory lesions)
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01135069

Locations
United States, Florida
MOORE Clinical Research, Inc.
Land O Lakes, Florida, United States, 34638
Sponsors and Collaborators
Spear Pharmaceuticals
  More Information

No publications provided

Responsible Party: K.L. Spear M.D., Spear Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01135069     History of Changes
Other Study ID Numbers: RAM-01
Study First Received: May 28, 2010
Last Updated: May 14, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tretinoin
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 21, 2013