Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Acne

Treatments: Drug: ACYC vehicle; Drug: ACYC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01701024

V01-ACYC-301

Details and patient eligibility

About

The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.

Full description

The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris

Enrollment: 498 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female between the ages of 12 and 40 (inclusive)
• Written and verbal informed consent must be obtained.
• Subjects less than 18 years of age must sign an assent for the study and a parent or a legal guardian must sign the informed consent
• Subject must have moderate to severe acne at the baseline visit
• Women of childbearing potential must be willing to practice effective contraception for the duration of the study

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
• Dermatological conditions on the face that could interfere with clinical evaluations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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498 participants in 2 patient groups, including a placebo group

ACYC

Active Comparator group

Description:

ACYC active, topically applied to the face for 12 weeks

Treatment:

Drug: ACYC

ACYC vehicle

Placebo Comparator group

Description:

ACYC vehicle (placebo), topically applied to the face for 12 weeks

Treatment:

Drug: ACYC vehicle