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

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ClinicalTrials.gov Identifier: NCT01243450
Recruitment Status : Completed
First Posted : November 18, 2010
Results First Posted : November 18, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Spear Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Acne Drug: Tretinoin Drug: placebo Phase 3

Detailed Description:
Acne study

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 958 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Acne Lesion Percent Reduction [ Time Frame: 12 week ]
    Reduction in number of Acne lesions by counting over 12 weeks



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

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.

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): 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

Responsible Party: Spear Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01243450     History of Changes
Other Study ID Numbers: RAM-04
First Posted: November 18, 2010    Key Record Dates
Results First Posted: November 18, 2014
Last Update Posted: November 18, 2014
Last Verified: November 2014

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