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

Primary Purpose

Acne

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IDP-121 Lotion
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Key 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.

Key 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.

Sites / Locations

  • Valeant Site 02
  • Valeant Site 01

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IDP-121 Lotion

Arm Description

Lotion

Outcomes

Primary Outcome Measures

Evaluators Global Severity Score at Day 15
Acne severity will be determined by the investigator/evaluator based on a 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).

Secondary Outcome Measures

Full Information

First Posted
July 6, 2016
Last Updated
December 12, 2017
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02849860
Brief Title
Absorption and Systematic Pharmacokinetics of IDP-121 Lotion in Subjects With Acne Vulgaris
Official Title
A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-121 Lotion in Subjects With Acne Vulgaris Under Maximal Use Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDP-121 Lotion
Arm Type
Experimental
Arm Description
Lotion
Intervention Type
Drug
Intervention Name(s)
IDP-121 Lotion
Other Intervention Name(s)
Lotion
Intervention Description
Lotion
Primary Outcome Measure Information:
Title
Evaluators Global Severity Score at Day 15
Description
Acne severity will be determined by the investigator/evaluator based on a 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).
Time Frame
15 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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. Key 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anya Loncaric
Organizational Affiliation
Valeant Pharmaceutical
Official's Role
Study Director
Facility Information:
Facility Name
Valeant Site 02
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Valeant Site 01
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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