A Study of a New Drug Treatment for Acne

Bausch Health Americas, Inc.431 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

431

Conditions

Acne Vulgaris

Interventions

1.2% JNJ 10229570-AAADRUG

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

2.4% JNJ 10229570-AAADRUG

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

3.6% JNJ 10229570-AAADRUG

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

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (18)

University of California, San Diego

San Diego, California, United States

University Clinical Trials, Inc.

San Diego, California, United States

Outcomes

Primary Outcomes

Change in Total Acne Lesion Counts

Change in lesion counts between baseline and end of study

Time frame: Baseline to Week 12

Secondary Outcomes

Change From Baseline in the Non-inflammatory Acne Lesion Counts

Change in sum of open and closed comedones.

Time frame: Baseline through Week 12

Change From Baseline in the Inflammatory Acne Lesion Counts

Change in sum of papules and pustules

Time frame: Baseline through Week 12

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)

Time frame: Baseline through Week 12

Percent Change From Baseline in the Inflammatory Acne Lesion Counts

Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules)

Time frame: Baseline through Week 12

Percent Change From Baseline in Total Acne Lesion Counts

Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions)

Time frame: Baseline through Week 12.

Data from ClinicalTrials.gov

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