A Study of a New Drug Treatment for Acne

Bausch Health

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: 1.2% JNJ 10229570-AAA; Drug: 3.6% JNJ 10229570-AAA; Other: Vehicle control; Drug: 2.4% JNJ 10229570-AAA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01326780

CA-P-8023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 431 patients

Sex: All

Ages: 12+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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431 participants in 4 patient groups, including a placebo group

1.2% Facial Cream

Experimental group

Description:

1.2% JNJ 10229570-AAA

Treatment:

Drug: 1.2% JNJ 10229570-AAA

2.4% Facial Cream

Experimental group

Description:

2.4% JNJ 10229570-AAA

Treatment:

Drug: 2.4% JNJ 10229570-AAA

3.6% Facial Cream

Experimental group

Description:

3.6% JNJ 10229570-AAA

Treatment:

Drug: 3.6% JNJ 10229570-AAA

0% Facial Cream

Placebo Comparator group

Description:

Vehicle control

Treatment:

Other: Vehicle control