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

Bausch Health

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03003247

V01-120A-201

Details and patient eligibility

About

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

Full description

A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Enrollment: 364 patients

Sex: All

Ages: 9+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female at least 9 years of age and older;
• Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit)
• Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening visit, and a negative urine pregnancy test at baseline visit.
• Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
• If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup.

Key Exclusion Criteria:

• Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
• Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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364 participants in 4 patient groups, including a placebo group

IDP-120 Gel

Experimental group

Description:

IDP-120 Gel is a combination treatment

Treatment:

Drug: IDP-120 Gel

IDP-120 Component A Gel

Active Comparator group

Description:

IDP-120 Monad Gel of Component A

Treatment:

Drug: IDP 120 Component A Gel

IDP-120 Component B Gel

Active Comparator group

Description:

IDP-120 Monad Gel of Component B

Treatment:

Drug: IDP 120 Component B Gel

IDP-120 Vehicle Gel

Placebo Comparator group

Description:

IDP-120 Vehicle Gel

Treatment:

Drug: IDP 120 Vehicle Gel