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Absorption and Systematic Pharmacokinetics of IDP-121 Lotion in Subjects With Acne Vulgaris

NCT ID: NCT02849860

Last Updated: 2017-12-14

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

2014-02-28

Study Completion Date

2016-10-31

Brief Summary

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Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant metabolites after topical dermal application of IDP-121 lotion.

Detailed Description

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Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant metabolites after topical dermal application of IDP-121 lotion in subjects with moderate to severe acne vulgaris under maximal use conditions.

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-121 Lotion

Lotion

Group Type EXPERIMENTAL

IDP-121 Lotion

Intervention Type DRUG

Lotion

Interventions

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IDP-121 Lotion

Lotion

Intervention Type DRUG

Other Intervention Names

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Lotion

Eligibility Criteria

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Inclusion Criteria

* Male or female, between the ages of 9 and \<17 years (16 years 11 months inclusive).
* Written and oral 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) to 4 (severe) on the Evaluator's Global Severity Assessment at the screening and baseline visit in the facial area.
* Subjects with facial acne inflammatory lesions count no less than 20 but no more than 40.
* Subjects with facial acne non-inflammatory lesions count no less than 20 but no more than 100.

Exclusion Criteria

* Use of investigational drug or device within 30 days of enrollment or participation in research study or concurrent study with this study.
* Any dermatological conditions on the face that could interfere with clinical evaluations acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinical significant rosacea, gram negative folliculitis.
* 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 facial beard or mustache that could interfere with any study assessments.
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 Pharmaceutical

Locations

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Valeant Site 02

Austin, Texas, United States

Site Status

Valeant Site 01

College Station, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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V01-121A-501

Identifier Type: -

Identifier Source: org_study_id