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

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.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Drug: Tretinoin; Drug: placebo

Detailed Description

Acne study

• Study Type: Interventional
• Enrollment (Actual): 958
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Mountain Lakes, New Jersey, United States, 07046
      • Cu-Tech, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active generic; Treatment of acne for 12 weeks with generic tretinoin	Drug: Tretinoin; Treatment of acne; Other Names: active medication
Placebo Comparator: Placebo; Treatment of acne for 12 weeks with Placebo	Drug: placebo; treatment of acne; Other Names: inactive medication
Active Comparator: Brand; Treatment of acne over 12 weeks with tretinoin Brand	Drug: Tretinoin; Treatment of acne; Other Names: active medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acne Lesion Percent Reduction	Reduction in number of Acne lesions by counting over 12 weeks	12 week

Collaborators and Investigators

• Sponsor: Spear Pharmaceuticals
• Investigators: Study Director: William Cunningham, MD, Cu-Tech

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: November 16, 2010
• First Submitted That Met QC Criteria: November 17, 2010
• First Posted (Estimate): November 18, 2010

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2019
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Dermatologic Agents; Keratolytic Agents; Tretinoin
• Other Study ID Numbers: RAM-04