A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

Valeant Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: IDP-121 Lotion; Drug: IDP-121 Vehicle Lotion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02535871

V01-121A-302

Details and patient eligibility

About

The primary objective of this study is to compare the efficacy, safety and tolerability of IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.

Full description

This is a multicenter, randomized, double-blind, parallel group, vehicle-controlled, 12-week study to evaluate relative changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Scale (EGSS) in subjects with moderate to severe acne. IDP-121 is a lotion for the topical treatment of acne.

Enrollment: 800 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 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 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
• Concomitant use of potentially irritating over-the-counter products

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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800 participants in 2 patient groups, including a placebo group

IDP-121 Lotion

Experimental group

Description:

IDP-121 Lotion, applied topically to the face, once daily for 12 weeks.

Treatment:

Drug: IDP-121 Lotion

IDP-121 Lotion Vehicle

Placebo Comparator group

Description:

IDP-121 Vehicle Lotion, applied topically to the face, once daily for 12 weeks

Treatment:

Drug: IDP-121 Vehicle Lotion