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Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison With Tazorac Cream

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ClinicalTrials.gov Identifier: NCT02849873
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
The Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison with Tazorac Cream.

Condition or disease Intervention/treatment Phase
Acne Drug: IDP-123 Lotion Drug: Tazorac Cream Phase 1

Detailed Description:
Randomized study evaluating the absorption and systematic pharmacokinetics of IDP-123 lotion in comparison with Tazorac Cream in subjects with moderate to severe acne vulgaris under maximal use conditions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-123 Lotion in Comparison With Tazorac Cream in Subjects With Moderate to Severe Acne Vulgaris Under Maximal Use Conditions
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Tazarotene

Arm Intervention/treatment
Experimental: IDp-123 Lotion
Lotion
Drug: IDP-123 Lotion
Lotion
Other Name: IDP-123

Active Comparator: Tazorac Cream
Cream
Drug: Tazorac Cream
Cream
Other Name: Tazorac




Primary Outcome Measures :
  1. Evaluator's Global Severity Score: At Day 15 (or ET), acne severity will be determined by the investigator/evaluator based on a global assessment of the inflammatory and non-inflammatory lesions of facial acne. [ Time Frame: 15 Days ]
    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 and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male or female, at least 9 years of age (at least 12 years of age for Tazorac Cream).
  • Verbal and written informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if the subject reaches age of consent during the study they should be re-consented at the next study visit).
  • Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the screening and baseline visit.
  • Subjects with facial acne inflammatory lesion 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 an investigational drug or device within 30 days of enrollment 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, dermatitis, eczema.
  • 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 count 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): NCT02849873


Locations
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United States, Alabama
Valeant Site 01
Birmingham, Alabama, United States, 35201
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Anya Loncaric Valeant Pharmaceuticals

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02849873     History of Changes
Other Study ID Numbers: V01-123A-501
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nicotinic Acids
Tazarotene
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs