A Study of a New Drug Treatment for Acne

• 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: Bausch Health Americas, Inc.
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Tracking Information

• First Submitted Date: March 30, 2011
• First Posted Date: March 31, 2011
• Results First Submitted Date: May 22, 2017
• Results First Posted Date: December 11, 2018
• Last Update Posted Date: October 16, 2019
• Actual Study Start Date: March 31, 2011
• Actual Primary Completion Date: March 31, 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Acne Vulgaris

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 21, 2012): 431
• Original Estimated Enrollment (submitted: March 30, 2011): 400
• Actual Study Completion Date: March 31, 2012
• Actual Primary Completion Date: March 31, 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01326780
• Other Study ID Numbers: CA-P-8023
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bausch Health Americas, Inc.
• Original Responsible Party: Joyce Hauze, RPS Sr Specialist, Clinical Research Operations, Johnson & Johnson Consumer and Personal Products Worldwide
• Current Study Sponsor: Bausch Health Americas, Inc.
• Original Study Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Collaborators: Not Provided

Investigators

• Study Director: Johnson Varughese; Bausch Health Americas, Inc.

• PRS Account: Bausch Health Americas, Inc.
• Verification Date: October 2019