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A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT03170388
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Brief Summary:
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: IDP-126 Gel Drug: IDP-126 Component A Drug: IDP-126 Component B Drug: IDP-126 Component C Drug: IDP-126 Vehicle Gel Phase 2

Detailed Description:
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : October 18, 2018
Estimated Study Completion Date : December 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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

Active Comparator: IDP-126 Component A
Component A
Drug: IDP-126 Component A
Component A

Active Comparator: IDP-126 Component B
Component B
Drug: IDP-126 Component B
Component B

Active Comparator: IDP-126 Component C
Component C
Drug: IDP-126 Component C
Component C

Placebo Comparator: IDP-126 Vehicle Gel
Vehicle Gel
Drug: IDP-126 Vehicle Gel
Vehicle Gel




Primary Outcome Measures :
  1. Inflammatory lesion counts [ Time Frame: Baseline to Week 12 ]
    Absolute change from Baseline to Week 12 in mean inflammatory lesion counts



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 99 Years   (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 and older.
  2. 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 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 an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.
  4. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100.
  5. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.
  6. Subjects with 2 or fewer facial nodules

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, gram negative 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 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): NCT03170388


Contacts
Contact: Karen Villaluna (650) 808-0493 karen.villaluna@valeant.com
Contact: Zach Pfauth 9085413279

  Show 34 Study Locations
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Anya Loncaric Valeant Pharmaceuticals International, Inc.

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT03170388     History of Changes
Other Study ID Numbers: V01-126A-201
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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