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

NCT ID: NCT03653403

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2019-06-19

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.

Conditions

Acne Vulgaris

Study Design

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

Study Groups

IDP-126 Gel

Component A

Group Type: EXPERIMENTAL

IDP-126 Gel

Intervention Type: DRUG

Component A

Control Gel

Gel

Group Type: ACTIVE_COMPARATOR

Control Gel

Intervention Type: DRUG

gel

Interventions

IDP-126 Gel

Component A

Intervention Type: DRUG

Control Gel

gel

Intervention Type: DRUG

Eligibility Criteria

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

• 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

Bausch Health Companies

Locations

Valeant Site 01

Austin, Texas, United States

Countries

United States

Other Identifiers

V01-126A-501

Identifier Type: -

Identifier Source: org_study_id