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Trial record 93 of 346 for:    acne AND facial

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.

Tracking Information
First Submitted Date  ICMJE March 30, 2011
First Posted Date  ICMJE March 31, 2011
Results First Submitted Date  ICMJE May 22, 2017
Results First Posted Date  ICMJE December 11, 2018
Last Update Posted Date October 16, 2019
Actual Study Start Date  ICMJE March 31, 2011
Actual Primary Completion Date March 31, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2011)
Change in Total Acne Lesion Counts [ Time Frame: Baseline to Week 12 ]
Change in lesion counts between baseline and end of study
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01326780 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
  • Change From Baseline in the Non-inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ]
    Change in sum of open and closed comedones.
  • Change From Baseline in the Inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ]
    Change in sum of papules and pustules
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2011)
  • Change From Baseline in the Non-inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ]
    Change in sum of open and closed comedones.
  • Change From Baseline in the Inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ]
    Change in sum of papules and pustules
  • Change from Baseline in Intermediate Total Acne Lesion Count [ Time Frame: Baseline through Week 10 ]
    Change in sum of inflammatory and non-inflammatory lesions throughout the study.
  • Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ]
    Percent Change in sum of open and closed comedones.
  • Percent Change From Baseline in the Inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ]
    Percent Change in sum of of papules and pustules.
  • Percent Change From Baseline in Total Acne Lesion Counts [ Time Frame: Baseline through Week 12. ]
    Percent change in inflammatory lesions and non-inflammatory lesions
  • Dichotomized Assessment of Improvement of Two Grades from Baseline Score [ Time Frame: Baseline through Week 12 ]
    Change from baseline in weekly Investigator's Global Assessment (IGA) scores, proportion of success according to Improvement of two grades from the baseline score
  • Dichotomized Assessment of Changes from Baseline in Clear or Almost Clear Grades [ Time Frame: Baseline through Week 12 ]
    Change from baseline in weekly IGA scores, proportion of success according to Clear or almost clear (Grades 0 or 1)
  • Changes in Combined Investigator's Global Assessment of Acne Severity (IGA) Score [ Time Frame: Baseline through Week 12 ]
    Change from baseline in weekly IGA scores, proportion of success according to dichotomized IGA using a combination of the following criteria: a) Improvement of two grades from the baseline score, b) Clear or almost clear (Grades 0 or 1)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of a New Drug Treatment for Acne
Official Title  ICMJE A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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
  • 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
  • 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
  • Other: Vehicle control
    Color matched cream vehicle, applied once daily to the face for 12 weeks
    Other Name: Not marketed
Study Arms  ICMJE
  • Experimental: 1.2% Facial Cream
    1.2% JNJ 10229570-AAA
    Intervention: Drug: 1.2% JNJ 10229570-AAA
  • Experimental: 2.4% Facial Cream
    2.4% JNJ 10229570-AAA
    Intervention: Drug: 2.4% JNJ 10229570-AAA
  • Experimental: 3.6% Facial Cream
    3.6% JNJ 10229570-AAA
    Intervention: Drug: 3.6% JNJ 10229570-AAA
  • Placebo Comparator: 0% Facial Cream
    Vehicle control
    Intervention: Other: Vehicle control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2012)
431
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2011)
400
Actual Study Completion Date  ICMJE March 31, 2012
Actual Primary Completion Date March 31, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01326780
Other Study ID Numbers  ICMJE CA-P-8023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson Varughese Bausch Health Americas, Inc.
PRS Account Bausch Health Americas, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP