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Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-126 Gel in Comparison With Control Gel

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ClinicalTrials.gov Identifier: NCT03653403
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Brief Summary:
This will be an open-label study designed to assess the safety and plasma PK of topically applied IDP-126 Gel compared to Control Gel.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: IDP-126 Gel Drug: Control Gel Phase 1

Detailed Description:
To evaluate the safety and plasma pharmacokinetics (PK) of clindamycin and adapalene in IDP-126 Gel compared with that from Control Gel in subjects with moderate to severe acne vulgaris (acne) during once daily topical application of IDP-126 Gel for 28 days.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Approximately 48 subjects who meet the study criteria will be enrolled and will receive treatment with one of the 2 study drugs. Approximately 20 subjects will be enrolled in the Control Gel treatment arm and approximately 28 subjects in the IDP-126 Gel treatment arm will be enrolled
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-126 Gel in Comparison With Control Gel in Subjects With Acne Vulgaris Under Maximal Use Conditions
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: IDP-126 Gel
Component A
Drug: IDP-126 Gel
Component A

Active Comparator: Control Gel
Gel
Drug: Control Gel
gel




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). [ Time Frame: All AEs will be followed from onset of the adverse event through the end of Study Day 28 visit ]
    During the study, subjects will be assessed for the occurrence of new and ongoing AEs. Descriptions of AEs will include the dates of onset and resolution, maximum severity, seriousness, action taken regarding study drug, corrective treatment, outcome, and investigator's assessment of causality. Worsening of disease will not be considered an AE unless it results in discontinuation of the subject from the study or requires medical intervention prohibited by the protocol.



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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

Inclusion Criteria:

  1. Male or female, at least 9 years of age (at least 12 years of age for Control Gel);
  2. Verbal and signed 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 subject reaches age of consent during the study they should be re-consented at the next study visit);
  3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the screening and baseline visit

Exclusion Criteria:

  1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
  2. Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis, dermatitis, eczema;
  3. 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;
  4. Subjects with a facial beard or mustache that could interfere with the study assessments;
  5. Subjects with more than two (2) facial nodules;
  6. Evidence or history of cosmetic-related acne

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): NCT03653403


Contacts
Contact: Steve Rodgers, PhD 9085413279 stephen.rodgers@bauschhealth.com
Contact: Zach Pfauth 9085413279 zachary.pfauth@bauschhealth.com

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

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT03653403     History of Changes
Other Study ID Numbers: V01-126A-501
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases