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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:
ClinicalTrials.gov Identifier:
NCT01135069
First Posted: June 2, 2010
Last Update Posted: October 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Spear Pharmaceuticals
  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: Brand Retin-A Micro tretinoin microsphere gel 0.1% Drug: placebo microsphere gel Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]
    Counting of acne lesions both inflammatory and non-inflammatory


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
treatment of acne for 12 weeks
Drug: Tretinoin microsphere 0.1%
Treatment of acne vulgaris
Active Comparator: Brand
Treatment of acne for 12 weeks
Drug: Brand Retin-A Micro tretinoin microsphere gel 0.1%
Treatment of acne vulgaris
Other Name: Retin-A Micro
Placebo Comparator: Placebo
Treatment if acne for 12 weeks as placebo
Drug: placebo microsphere gel
treatment of acne vulgaris

Detailed Description:
Not required
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135069


Locations
United States, Florida
Moore Clinical Research
Land O Lakes, Florida, United States, 34628
Sponsors and Collaborators
Spear Pharmaceuticals
Investigators
Principal Investigator: Krunal Patel, MD Moore Clinical Research
  More Information

Responsible Party: Spear Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01135069     History of Changes
Other Study ID Numbers: RAM-01
First Submitted: May 28, 2010
First Posted: June 2, 2010
Results First Submitted: May 28, 2013
Results First Posted: October 16, 2014
Last Update Posted: October 27, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents