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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014