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

Spear Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Acne

Treatments: Drug: placebo; Drug: Tretinoin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01243450

RAM-04

Details and patient eligibility

About

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.

Full description

Acne study

Enrollment: 958 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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958 participants in 3 patient groups, including a placebo group

Active generic

Active Comparator group

Description:

Treatment of acne for 12 weeks with generic tretinoin

Treatment:

Drug: Tretinoin

Placebo

Placebo Comparator group

Description:

Treatment of acne for 12 weeks with Placebo

Treatment:

Drug: placebo

Brand

Active Comparator group

Description:

Treatment of acne over 12 weeks with tretinoin Brand

Treatment:

Drug: Tretinoin