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Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel

NCT ID: NCT02850003

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-11-30

Brief Summary

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

Detailed Description

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

Conditions

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Acne

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IDP-120 Gel

Gel

Group Type EXPERIMENTAL

IDP-120 Gel

Intervention Type DRUG

Gel

Interventions

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IDP-120 Gel

Gel

Intervention Type DRUG

Other Intervention Names

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Gel

Eligibility Criteria

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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.

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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anya Loncaric

Role: STUDY_DIRECTOR

Valeant Pharmaceuticals

Locations

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Valeant Site 01

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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V01-120A-501

Identifier Type: -

Identifier Source: org_study_id