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A Study of a New Drug Treatment for Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01326780
Recruitment Status : Completed
First Posted : March 31, 2011
Results First Posted : December 11, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Description
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Brief Summary:
A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: 1.2% JNJ 10229570-AAA Drug: 2.4% JNJ 10229570-AAA Drug: 3.6% JNJ 10229570-AAA Other: Vehicle control Phase 2

Detailed Description:
Approximately 400 male and female subjects with moderate facial acne vulgaris will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, subjects will be randomized to either 1.2%, 2.4%, or 3.6% facial cream (JNJ 10229570-AAA) or color-matched vehicle. Subjects will apply the study medication once daily on the face for 12 weeks. Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at Baseline and at Weeks 2, 4, 6, 8, 10, and 12. Approximately 50 subjects from one investigational site also will have serums collected at Weeks 6 and 12 for evaluation of the multiple dose pharmacokinetics of JNJ 10229570-AAA cream.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 431 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris
Actual Study Start Date : March 31, 2011
Actual Primary Completion Date : March 31, 2012
Actual Study Completion Date : March 31, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1.2% Facial Cream
1.2% JNJ 10229570-AAA
 Drug: 1.2% JNJ 10229570-AAA
1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
Other Name: Not yet marketed
Experimental: 2.4% Facial Cream
2.4% JNJ 10229570-AAA
 Drug: 2.4% JNJ 10229570-AAA
2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
Other Name: Not yet marketed
Experimental: 3.6% Facial Cream
3.6% JNJ 10229570-AAA
 Drug: 3.6% JNJ 10229570-AAA
3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
Other Name: Not yet marketed
Placebo Comparator: 0% Facial Cream
Vehicle control
 Other: Vehicle control
Color matched cream vehicle, applied once daily to the face for 12 weeks
Other Name: Not marketed


Outcome Measures
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Primary Outcome Measures :
  1. Change in Total Acne Lesion Counts [ Time Frame: Baseline to Week 12 ]
    Change in lesion counts between baseline and end of study


Secondary Outcome Measures :
  1. Change From Baseline in the Non-inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ]
    Change in sum of open and closed comedones.

  2. Change From Baseline in the Inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ]
    Change in sum of papules and pustules

  3. Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ]
    Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones)

  4. Percent Change From Baseline in the Inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ]
    Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules)

  5. Percent Change From Baseline in Total Acne Lesion Counts [ Time Frame: Baseline through Week 12. ]
    Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions)


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12 years of age or older, with moderate facial acne vulgaris as defined in the protocol
  • If female of childbearing potential, must take a pregnancy test and have a negative result

  • Females of childbearing potential must also agree to use an adequate method of birth control, which would include:

    • systemic birth control (Subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change type of birth control during the study)
    • Condom with spermicide
    • IUD. Females who have had a hysterectomy, bilateral oophorectomy or bilateral tubal ligation are not required to use additional birth control methods

Exclusion Criteria:

  • Known sensitivity to any of the ingredients in the study medication
  • More than 3 nodulocystic acne lesions
  • Use of acne treatments, therapies or medications within protocol-specified timeframes
  • Presence of other skin conditions, diseases, or medical conditions that (per protocol or in the opinion of the investigator) may require concurrent therapy, interfere with the evaluation of the study medication, or compromise subject safety
  • Excessive facial hair that may interfere with application of the medication and/or evaluations
Contacts and Locations
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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): NCT01326780


Locations
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Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Johnson Varughese Bausch Health Americas, Inc.
More Information
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Additional Information:

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01326780    
Other Study ID Numbers: CA-P-8023
First Posted: March 31, 2011    Key Record Dates
Results First Posted: December 11, 2018
Last Update Posted: October 16, 2019
Last Verified: October 2019
Keywords provided by Bausch Health Americas, Inc.:
Acne
Irritation
Safety
Sebum
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases