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

Phase 1

Completed

• Conditions: Acne
• Interventions: Drug: Tazorac Cream; Drug: IDP-123 Lotion

• Registration Number: NCT02849873
• Lead Sponsor: Bausch Health Americas, Inc.

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-29
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tazorac Cream	Tazorac Cream	Cream
IDp-123 Lotion	IDP-123 Lotion	Lotion

Primary Outcome Measures

Name	Time	Method
Evaluator's Global Severity Score: At Day 15 (or ET), acne severity will be determined by the investigator/evaluator based on a global assessment of the inflammatory and non-inflammatory lesions of facial acne.	15 Days	Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe)

Trial Locations

Locations (1)

Valeant Site 01; 🇺🇸 Birmingham, Alabama, United States