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Trial record 4 of 164 for:    acne AND Vehicle

Efficacy and Safety of IDP-121 Lotion and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02965456
Recruitment Status : Completed
First Posted : November 16, 2016
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
Efficacy and Safety of IDP-121 Lotion and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

Condition or disease Intervention/treatment Phase
Acne Drug: IDP 121 Lotion Drug: IDP-121 Vehicle Lotion Phase 3

Detailed Description:
A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 Lotion and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 Lotion and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Actual Study Start Date : October 30, 2015
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : April 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: IDP-121 Lotion
Lotion
Drug: IDP 121 Lotion
Lotion
Other Name: Lotion

Placebo Comparator: IDP-121 Vehicle Lotion
Vehicle
Drug: IDP-121 Vehicle Lotion
Lotion
Other Name: Vehicle




Primary Outcome Measures :
  1. Percent of Subjects who achieve at least a two grade reduction from baseline and are Clear -or almost clear at week 12 in the evaluators Global Severity Score [ Time Frame: 12 weeks ]
    The Global Severity Score ranged from 1 (clear) to 5 (Severe)



Information from the National Library of Medicine

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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 and older.
  • 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)
  • Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
  • If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup.

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 conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative 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 a facial beard or mustache that could interfere with the study assessments.
  • History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of tretinoin.
  • Subjects who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
  • Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating in the study.

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): NCT02965456


  Show 34 Study Locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Chair: Tim Theisen TKL Research, Inc.

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02965456     History of Changes
Other Study ID Numbers: V01-121A-302
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases