Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison With Tazorac Cream

Bausch Health

Status and phase

Completed

Phase 1

Conditions

Acne

Treatments

Drug: IDP-123 Lotion

Drug: Tazorac Cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT02849873

V01-123A-501

Details and patient eligibility

About

The Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison with Tazorac Cream.

Full description

Randomized study evaluating the absorption and systematic pharmacokinetics of IDP-123 lotion in comparison with Tazorac Cream in subjects with moderate to severe acne vulgaris under maximal use conditions.

Enrollment

48 patients

Sex

All

Ages

9+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Male or female, at least 9 years of age (at least 12 years of age for Tazorac Cream).
Verbal and written 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 the subject reaches age of consent during the study they should be re-consented at the next study visit).
Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the screening and baseline visit.
Subjects with facial acne inflammatory lesion count no less than 20 but no more than 40.
Subjects with facial acne non-inflammatory lesions 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 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, dermatitis, eczema.
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 count inconclusive.
Subjects with a facial beard or mustache that could interfere with the study assessments.
Subjects with more than 2 facial nodules.