Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel

Bausch Health

Status and phase

Completed

Phase 1

Conditions

Acne

Treatments

Drug: IDP-120 Gel

Study type

Interventional

Funder types

Industry

Identifiers

V01-120A-501

Details and patient eligibility

About

Study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.

Full description

An Open-label study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.

Enrollment

20 patients

Sex

All

Ages

9 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Male or female between the ages of 9 and <17 (16 years 11 months)
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 legal guardian must sign the informed consent.
Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment.
Subject with facial acne inflammatory lesion count no less than 20 but no more than 40.
Subject with facial acne non-inflammatory lesion count no less than 20 but no more than 100.

Key Exclusion Criteria:

Use of an investigational drug or device within 30 days of enrollment, previous participation in a research study with IDP-120 Gel, 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 conglobate, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis.
Any underlying disease or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion counts inconclusive.
Subjects with a facial beard or mustache that could interfere with the study assessments
Subjects with more than 2 facial nodules.