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OpenTrials
Completed

NCT Number: NCT01326780

A Study of a New Drug Treatment for Acne

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Clinical Trials, Inc., San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1.2% JNJ 10229570-AAA

Drug

1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks

Other names: Not yet marketed

2.4% JNJ 10229570-AAA

Drug

2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks

Other names: Not yet marketed

3.6% JNJ 10229570-AAA

Drug

3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks

Other names: Not yet marketed

Vehicle Control

Other

Color matched cream vehicle, applied once daily to the face for 12 weeks

Other names: Not marketed

Primary outcomes

  1. Change in Total Acne Lesion Counts

    Time frame: Baseline to Week 12

    Change in lesion counts between baseline and end of study

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 31, 2011
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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