Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel

A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel in Subjects With Acne Vulgaris Under Maximal Use Conditions

Study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Drug: IDP-120 Gel

Detailed Description

An Open-label study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78759
      • Valeant Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Male or female between the ages of 9 and <17 (16 years 11 months)
• Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or legal guardian must sign the informed consent.
• Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment.
• Subject with facial acne inflammatory lesion count no less than 20 but no more than 40.
• Subject with facial acne non-inflammatory lesion 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, previous participation in a research study with IDP-120 Gel, 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.
• 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 counts inconclusive.
• Subjects with a facial beard or mustache that could interfere with the study assessments
• Subjects with more than 2 facial nodules.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDP-120 Gel; Gel	Drug: IDP-120 Gel; Gel; Other Names: Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluators Global Severity Score At Day 15	Acne severity will be determined by the investigator/evaluator based on the global assessment of the inflammatory and non-inflammatory lesions of facial acne. Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe).	15 Days

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 20, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: V01-120A-501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO