Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo

This study has been completed.
Sponsor:
Information provided by:
Spear Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01243450
First received: November 16, 2010
Last updated: November 17, 2010
Last verified: November 2010
  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
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo

Resource links provided by NLM:


Further study details as provided by Spear Pharmaceuticals:

Primary Outcome Measures:
  • Acne lesion improvement [ Time Frame: 12 week ] [ Designated as safety issue: No ]

Enrollment: 955
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active generic Drug: Tretinoin
Topical skin
Placebo Comparator: Placebo Drug: Tretinoin
Topical skin
Drug: placebo
Active Comparator: Brand Drug: Tretinoin
Topical skin

  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion 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: NCT01243450

Locations
United States, New Jersey
Cu-Tech, LLC
Mountain Lakes, New Jersey, United States, 07046
Sponsors and Collaborators
Spear Pharmaceuticals
  More Information

No publications provided

Responsible Party: K.L. Spear, Spear Pharmaceuiticals
ClinicalTrials.gov Identifier: NCT01243450     History of Changes
Other Study ID Numbers: RAM-04
Study First Received: November 16, 2010
Last Updated: November 17, 2010
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 April 16, 2014