Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris

Valeant Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Tazorac Cream, 0.1%,; Drug: Vehicle Lotion; Drug: Vehicle Cream; Drug: IDP-123 Lotion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02525822

V01-123A-201

Details and patient eligibility

About

The primary objective of this study is to compare the safety and efficacy of once daily application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne vulgaris.

Full description

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-123 Lotion in comparison with Tazorac Cream, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne. Treatment success will be evaluated by changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Score. IDP-123 is a lotion for the topical treatment of acne.

Enrollment: 210 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female at least 12 years of age and older
• Written and verbal informed consent must be obtained
• Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment
• Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits
• Subjects must be willing to comply with study instructions and return to the clinic for required visits

Exclusion criteria

• Any dermatological conditions on the face that could interfere with clinical evaluations
• Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
• Subjects with a facial beard or mustache that could interfere with the study assessments
• Subjects who are unable to communicate or cooperate with the Investigator
• Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 4 patient groups, including a placebo group

IDP-123 Lotion

Experimental group

Description:

IDP-123 Lotion, applied topically to the face, once daily for 12 weeks.

Treatment:

Drug: IDP-123 Lotion

Tazorac Cream, 0.1%

Active Comparator group

Description:

Tazorac Cream (tazarotene 0.1%), applied topically to the face, once daily for 12 weeks.

Treatment:

Drug: Tazorac Cream, 0.1%,

Vehicle Cream

Placebo Comparator group

Description:

Vehicle Cream, applied topically to the face, once daily for 12 weeks.

Treatment:

Drug: Vehicle Cream

Vehicle Lotion

Placebo Comparator group

Description:

Vehicle Lotion, applied topically to the face, once daily for 12 weeks.

Treatment:

Drug: Vehicle Lotion