NCT01492647

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of JNJ 10229570-AAA after a single topical application of JNJ 10229570-AAA 1.2% and 3.6% cream in Japanese participants with acne.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

2 months

First QC Date

December 13, 2011

Last Update Submit

February 18, 2013

Conditions

Acne Vulgaris

Keywords

Acne vulgarisJNJ 10229570-AAAJapanese patientsTopical treatment

Outcome Measures

Primary Outcomes (1)

  • Topical Dermatological Assessment (Scores on Scales)

    The Topical Dermatological Assessment is based on the 3 to 4-point Cutaneous Irritation Grading Scales that assess the level of Erythema, Dryness, Peeling/Scaling, Burning/Stinging, and Itching from 0 (no reaction) to 3 or 4 (strong reaction). In addition, the assessment observes and records any pigmentation change that may occur on the skin after the intervention.

    Days 1-7

Secondary Outcomes (2)

  • Plasma M1 concentrations

    12 time points up to 72 hours

  • PK parameters

    12 time points up to 72 hours

Study Arms (2)

JNJ 10229570-AAA 1.2%

EXPERIMENTAL
Drug: JNJ 10229570-AAA 1.2%Drug: Color-matched vehicle containing 0 mg of JNJ 10229570-AAA

JNJ 10229570-AAA 3.6%

EXPERIMENTAL
Drug: JNJ 10229570-AAA 3.6%Drug: Color-matched vehicle containing 0 mg of JNJ 10229570-AAA

Interventions

JNJ 10229570-AAA 1.2%DRUG

One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas.

JNJ 10229570-AAA 1.2%
JNJ 10229570-AAA 3.6%DRUG

One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas.

JNJ 10229570-AAA 3.6%
Color-matched vehicle containing 0 mg of JNJ 10229570-AAADRUG

One single application of 2.5 mL of the color-matched vehicle will be applied to the face, neck, shoulders, chest and to the upper back areas.

JNJ 10229570-AAA 1.2%JNJ 10229570-AAA 3.6%

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Have Acne vulgaris, presenting at least inflammatory lesion on the face
  • Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg (man) or 45 kg (woman)
  • Blood pressure between 90 and 140 mmHg systolic (inclusive), and no higher than 90 mmHg diastolic
  • Electrocardiogram (ECG) consistent with normal cardiac conduction and function
  • Non-smoker
  • Adequate contraception method for both men and women. If a woman, must have a negative pregnancy test
  • Signed an informed consent document

You may not qualify if:

  • History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for hematology, biochemistry or urinalysis
  • Clinically significant abnormal physical examination, vital signs or ECG - Use of any prescription or nonprescription medication within 14 days before the study treatment
  • History of drug or alcohol abuse within the past 5 years
  • Drug allergy or drug hypersensitivity
  • Blood donation, depending on the volume of blood collection
  • Positive test for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis
  • Dermatological disease at application site
  • Photosensitivity
  • Exposure to excessive or chronic ultraviolet (UV) radiation (i.e., sunbathing, tanning salon use, phototherapy) within 4 weeks prior to study treatment or planned during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Fukukoka, Japan

Location

Unknown Facility

Hakata, Japan

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Janssen Pharmaceutical K.K., Japan Clinical Trial

    Janssen Pharmaceutical K.K.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 15, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

JP(2)