Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-126 Gel in Comparison With Control Gel

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Control Gel; Drug: IDP-126 Gel

• Registration Number: NCT03653403
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

This will be an open-label study designed to assess the safety and plasma PK of topically applied IDP-126 Gel compared to Control Gel.

Detailed Description

To evaluate the safety and plasma pharmacokinetics (PK) of clindamycin and adapalene in IDP-126 Gel compared with that from Control Gel in subjects with moderate to severe acne vulgaris (acne) during once daily topical application of IDP-126 Gel for 28 days.

Study Timeline

• Study Start: 2018-08-08
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Primary Completion: 2019-06-19
• Study Completion: 2019-06-19
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

1. Male or female, at least 9 years of age (at least 12 years of age for Control Gel);
2. Verbal and signed 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 subject reaches age of consent during the study they should be re-consented at the next study visit);
3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the screening and baseline visit

Exclusion Criteria

1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
2. Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis, dermatitis, eczema;
3. Any underlying disease(s) 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;
4. Subjects with a facial beard or mustache that could interfere with the study assessments;
5. Subjects with more than two (2) facial nodules;
6. Evidence or history of cosmetic-related acne

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Gel	Control Gel	Gel
IDP-126 Gel	IDP-126 Gel	Component A

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).	All AEs will be followed from onset of the adverse event through the end of Study Day 28 visit	During the study, subjects will be assessed for the occurrence of new and ongoing AEs. Descriptions of AEs will include the dates of onset and resolution, maximum severity, seriousness, action taken regarding study drug, corrective treatment, outcome, and investigator's assessment of causality. Worsening of disease will not be considered an AE unless it results in discontinuation of the subject from the study or requires medical intervention prohibited by the protocol.

Trial Locations

Locations (1)

Valeant Site 01; 🇺🇸 Austin, Texas, United States