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Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel

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ClinicalTrials.gov Identifier: NCT02850003
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

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

Condition or disease Intervention/treatment Phase
Acne Drug: IDP-120 Gel Phase 1

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  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : June 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: IDP-120 Gel
Gel
Drug: IDP-120 Gel
Gel
Other Name: Gel




Primary Outcome Measures :
  1. Evaluators Global Severity Score At Day 15 [ Time Frame: 15 Days ]
    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).



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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850003


Locations
United States, Texas
Valeant Site 01
Austin, Texas, United States, 78759
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Anya Loncaric Valeant Pharmaceuticals

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT02850003     History of Changes
Other Study ID Numbers: V01-120A-501
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No