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

NCT03653403 | Completed Phase 1 FDA Drug

• 1 other identifier: V01-126A-501
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

  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.

  All AEs will be followed from onset of the adverse event through the end of Study Day 28 visit

Study Arms (2)

IDP-126 Gel

EXPERIMENTAL

Component A

Drug: IDP-126 Gel

Control Gel

ACTIVE COMPARATOR

Gel

Drug: Control Gel

Interventions

IDP-126 Gel DRUG

Component A

IDP-126 Gel

Control Gel DRUG

gel

Control Gel

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Valeant Site 01

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Anya Loncaric

  Bausch Health Companies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 enrolled

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 31, 2018
• Study Start: August 8, 2018
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: October 21, 2019

Record last verified: 2019-10

Locations

US (1)