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A Study of a New Drug Treatment for Acne

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
1.2% JNJ 10229570-AAA
2.4% JNJ 10229570-AAA
3.6% JNJ 10229570-AAA
Vehicle control
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, Irritation, Safety, Sebum

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Diego
  • University Clinical Trials, Inc.
  • Thomas J. Stephens & Associates, Inc.
  • Horizons Clinical Research Ctr., LLC
  • North Florida Dermatology
  • Hilltop Research
  • Gwinnett Clinical Research
  • Northwestern University
  • Dermatology Specialists Research, Inc
  • Minnesota Clinical Study Center
  • TKL Research
  • Academic Dermatology Associates
  • Wake Research Associates
  • Hilltop Research
  • Penn State Medical Center
  • Yardley Dermatology Associates
  • Research Across America
  • Reliance Clinical Testing Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1.2% Facial Cream

2.4% Facial Cream

3.6% Facial Cream

0% Facial Cream

Arm Description

1.2% JNJ 10229570-AAA

2.4% JNJ 10229570-AAA

3.6% JNJ 10229570-AAA

Vehicle control

Outcomes

Primary Outcome Measures

Change in Total Acne Lesion Counts
Change in lesion counts between baseline and end of study

Secondary Outcome Measures

Change From Baseline in the Non-inflammatory Acne Lesion Counts
Change in sum of open and closed comedones.
Change From Baseline in the Inflammatory Acne Lesion Counts
Change in sum of papules and pustules
Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts
Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones)
Percent Change From Baseline in the Inflammatory Acne Lesion Counts
Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules)
Percent Change From Baseline in Total Acne Lesion Counts
Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions)

Full Information

First Posted
March 30, 2011
Last Updated
October 2, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01326780
Brief Title
A Study of a New Drug Treatment for Acne
Official Title
A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 31, 2011 (Actual)
Primary Completion Date
March 31, 2012 (Actual)
Study Completion Date
March 31, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne, Irritation, Safety, Sebum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
431 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.2% Facial Cream
Arm Type
Experimental
Arm Description
1.2% JNJ 10229570-AAA
Arm Title
2.4% Facial Cream
Arm Type
Experimental
Arm Description
2.4% JNJ 10229570-AAA
Arm Title
3.6% Facial Cream
Arm Type
Experimental
Arm Description
3.6% JNJ 10229570-AAA
Arm Title
0% Facial Cream
Arm Type
Placebo Comparator
Arm Description
Vehicle control
Intervention Type
Drug
Intervention Name(s)
1.2% JNJ 10229570-AAA
Other Intervention Name(s)
Not yet marketed
Intervention Description
1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
Intervention Type
Drug
Intervention Name(s)
2.4% JNJ 10229570-AAA
Other Intervention Name(s)
Not yet marketed
Intervention Description
2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
Intervention Type
Drug
Intervention Name(s)
3.6% JNJ 10229570-AAA
Other Intervention Name(s)
Not yet marketed
Intervention Description
3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
Intervention Type
Other
Intervention Name(s)
Vehicle control
Other Intervention Name(s)
Not marketed
Intervention Description
Color matched cream vehicle, applied once daily to the face for 12 weeks
Primary Outcome Measure Information:
Title
Change in Total Acne Lesion Counts
Description
Change in lesion counts between baseline and end of study
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in the Non-inflammatory Acne Lesion Counts
Description
Change in sum of open and closed comedones.
Time Frame
Baseline through Week 12
Title
Change From Baseline in the Inflammatory Acne Lesion Counts
Description
Change in sum of papules and pustules
Time Frame
Baseline through Week 12
Title
Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts
Description
Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones)
Time Frame
Baseline through Week 12
Title
Percent Change From Baseline in the Inflammatory Acne Lesion Counts
Description
Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules)
Time Frame
Baseline through Week 12
Title
Percent Change From Baseline in Total Acne Lesion Counts
Description
Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions)
Time Frame
Baseline through Week 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson Varughese
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University Clinical Trials, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Thomas J. Stephens & Associates, Inc.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80915
Country
United States
Facility Name
Horizons Clinical Research Ctr., LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
North Florida Dermatology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Hilltop Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Gwinnett Clinical Research
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dermatology Specialists Research, Inc
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
TKL Research
City
Rochelle Park
State/Province
New Jersey
ZIP/Postal Code
07662
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Hilltop Research
City
Miamiville
State/Province
Ohio
ZIP/Postal Code
45147
Country
United States
Facility Name
Penn State Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Yardley Dermatology Associates
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Reliance Clinical Testing Services
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Description
FDA's Drug Finder

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A Study of a New Drug Treatment for Acne

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