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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 (Responsible Party):
Spear Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01243450
First received: November 16, 2010
Last updated: November 17, 2014
Last verified: November 2014
  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 Percent Reduction [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    Reduction in number of Acne lesions by counting over 12 weeks


Enrollment: 958
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
Treatment of acne for 12 weeks with generic tretinoin
Drug: Tretinoin
Treatment of acne
Other Name: active medication
Placebo Comparator: Placebo
Treatment of acne for 12 weeks with Placebo
Drug: placebo
treatment of acne
Other Name: inactive medication
Active Comparator: Brand
Treatment of acne over 12 weeks with tretinoin Brand
Drug: Tretinoin
Treatment of acne
Other Name: active medication

Detailed Description:

Acne study

  Eligibility

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

A subject will be eligible to participate if they meet all of the following inclusion criteria:

  • Normal, healthy male and female children and adults.
  • Age 12 to 40 years.
  • Written and verbal informed consent must be obtained. Subjects age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent (per FDA letter 8.21.07).
  • 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, adequate contraception is defined as regular use of any two of the following: oral, injectable contraceptives, condoms, spermicides, diaphragm, IUD, implantable and contraceptive patches. (oral contraceptives if used for at least three months and injectable contraceptives if used for at least 6 months)- prior to enrollment in the study, or abstinence.
  • Have at least 20 inflammatory (papules and pustules) and 25 non-inflammatory (open and closed comedones) lesions with a maximum of 2 nodulocystic lesions on the face (per FDA letter 8.21.07).
  • Global severity score from 2-4
  • 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

A subject will be eligible to participate if they meet none of the following exclusion criteria:

  • Subjects with active cystic acne as evidenced by more than 2 facial nodules.
  • More than 40 papules and/or pustules (inflammatory lesions)
  • More than 60 open and or closed comedones/milia (non-inflammatory lesions)
  • Overall severity grade of less than 2 or greater than 4,
  • History of allergy or hypersensitivity to tretinoin.
  • Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease
  • Use of systemic retinoid treatment within six months prior to study initiation.
  • Oral contraceptives should not be started or changed within 3 months prior to study initiation or planned to change during the study.
  • Pregnant or breast-feeding.
  • Participation in a clinical study for acne within 4 months 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: NCT01243450

Locations
United States, New Jersey
Cu-Tech, LLC
Mountain Lakes, New Jersey, United States, 07046
Sponsors and Collaborators
Spear Pharmaceuticals
Investigators
Study Director: William Cunningham, MD Cu-Tech
  More Information

No publications provided

Responsible Party: Spear Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01243450     History of Changes
Other Study ID Numbers: RAM-04
Study First Received: November 16, 2010
Results First Received: September 7, 2014
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014