A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Bausch Health

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: IDP-126 Gel; Drug: IDP-126 Component A; Drug: IDP-126 Component C; Drug: IDP-126 Component B; Drug: IDP-126 Vehicle Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03170388

V01-126A-201

Details and patient eligibility

About

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Full description

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Enrollment: 741 patients

Sex: All

Ages: 9 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female at least 9 years of age and older.
2. 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).
3. Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.
4. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100.
5. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.
6. Subjects with 2 or fewer facial nodules

Exclusion criteria

1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
2. 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, gram negative folliculitis, dermatitis, eczema.
3. 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.
4. Subjects with a facial beard or mustache that could interfere with the study assessments.
5. Subjects with more than 2 facial nodules.
6. Evidence or history of cosmetic-related acne.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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741 participants in 5 patient groups, including a placebo group

IDP-126 Gel

Experimental group

Description:

Gel

Treatment:

Drug: IDP-126 Gel

IDP-126 Component A

Active Comparator group

Description:

Component A

Treatment:

Drug: IDP-126 Component A

IDP-126 Component B

Active Comparator group

Description:

Component B

Treatment:

Drug: IDP-126 Component B

IDP-126 Component C

Active Comparator group

Description:

Component C

Treatment:

Drug: IDP-126 Component C

IDP-126 Vehicle Gel

Placebo Comparator group

Description:

Vehicle Gel

Treatment:

Drug: IDP-126 Vehicle Gel