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

Sponsor

Bausch Health Americas, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03653403

Collaborator

(none)

Enrollment

Location

Arms

10.3

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: IDP-126 Gel Drug: Control Gel	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Approximately 48 subjects who meet the study criteria will be enrolled and will receive treatment with one of the 2 study drugs. Approximately 20 subjects will be enrolled in the Control Gel treatment arm and approximately 28 subjects in the IDP-126 Gel treatment arm will be enrolledApproximately 48 subjects who meet the study criteria will be enrolled and will receive treatment with one of the 2 study drugs. Approximately 20 subjects will be enrolled in the Control Gel treatment arm and approximately 28 subjects in the IDP-126 Gel treatment arm will be enrolled

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-126 Gel in Comparison With Control Gel in Subjects With Acne Vulgaris Under Maximal Use Conditions

Actual Study Start Date :

Aug 8, 2018

Actual Primary Completion Date :

Jun 19, 2019

Actual Study Completion Date :

Jun 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDP-126 Gel Component A	Drug: IDP-126 Gel Component A
Active Comparator: Control Gel Gel	Drug: Control Gel gel

Arm

Intervention/Treatment

Experimental: IDP-126 Gel

Component A

Drug: IDP-126 Gel

Component A

Active Comparator: Control Gel

Gel

Drug: Control Gel

gel

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female, at least 9 years of age (at least 12 years of age for Control Gel);
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);
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:

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 conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis, dermatitis, eczema;
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;
Subjects with a facial beard or mustache that could interfere with the study assessments;
Subjects with more than two (2) facial nodules;
Evidence or history of cosmetic-related acne

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valeant Site 01	Austin	Texas	United States	78759

Sponsors and Collaborators

Bausch Health Americas, Inc.

Investigators

Study Director: Anya Loncaric, Bausch Health Companies

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bausch Health Americas, Inc.

ClinicalTrials.gov Identifier:

NCT03653403

Other Study ID Numbers:

V01-126A-501

First Posted:

Aug 31, 2018

Last Update Posted:

Oct 21, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acne Vulgaris

Study Results

No Results Posted as of Oct 21, 2019