A Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Valeant Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: IDP-120 Vehicle Gel; Drug: IDP-120 Gel; Drug: IDP-120 Component A; Drug: IDP-120 Component B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02537483

V01-120A-201

Details and patient eligibility

About

The primary objective of this study is to compare the efficacy, safety, and tolerability of IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel 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-120 Gel in comparison with IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12 in subjects with moderate to severe acne. IDP-120 is a gel for the topical treatment of acne.

Enrollment: 350 estimated patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female at least 9 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 at the screening and baseline visit
• Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at 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 subject's safety while participating in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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350 participants in 4 patient groups, including a placebo group

IDP-120 Gel

Experimental group

Description:

IDP-120 Gel, applied topically to the face once daily for 12 weeks.

Treatment:

Drug: IDP-120 Gel

IDP-120 Component A

Active Comparator group

Description:

IDP-120 Component A, applied topically to the face once daily for 12 weeks

Treatment:

Drug: IDP-120 Component A

IDP-120 Component B

Active Comparator group

Description:

IDP-120 Component B, applied topically to the face once daily for 12 weeks

Treatment:

Drug: IDP-120 Component B

IDP-120 Vehicle Gel

Placebo Comparator group

Description:

IDP-120 Vehicle Gel, applied topically to the face once daily for 12 weeks

Treatment:

Drug: IDP-120 Vehicle Gel