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

NCT ID: NCT02849873

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-01-31

Brief Summary

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

Detailed 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.

Conditions

Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IDp-123 Lotion

Lotion

Group Type: EXPERIMENTAL

IDP-123 Lotion

Intervention Type: DRUG

Lotion

Tazorac Cream

Cream

Group Type: ACTIVE_COMPARATOR

Tazorac Cream

Intervention Type: DRUG

Cream

Interventions

IDP-123 Lotion

Lotion

Intervention Type: DRUG

Tazorac Cream

Cream

Intervention Type: DRUG

Other Intervention Names

IDP-123; Tazorac

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anya Loncaric

Role: STUDY_DIRECTOR

Valeant Pharmaceuticals

Locations

Valeant Site 01

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

V01-123A-501

Identifier Type: -

Identifier Source: org_study_id