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A Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Participants With Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
JNJ 10229570-AAA 1.2%
JNJ 10229570-AAA 3.6%
Color-matched vehicle containing 0 mg of JNJ 10229570-AAA
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne vulgaris, JNJ 10229570-AAA, Japanese patients, Topical treatment

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

JNJ 10229570-AAA 1.2%

JNJ 10229570-AAA 3.6%

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Plasma M1 concentrations
PK parameters
PK parameters of JNJ-10229570-AAA, as measured by AUC, Cmax and tmax

Full Information

First Posted
December 13, 2011
Last Updated
February 18, 2013
Sponsor
Janssen Pharmaceutical K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT01492647
Brief Title
A Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Participants With Acne Vulgaris
Official Title
A Randomized, Double Blinded, Single Topical Dose Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Subjects With Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a randomized (drug assigned by chance like flipping a coin), double blinded (neither physician nor patient knows the name of the assigned drug), single dose ascending study of JNJ 10229570-AAA in Japanese participants with acne. The study will evaluate the safety and pharmacokinetics ([PK] how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) of M1 (active metabolite) in a total of eighteen (18) participants enrolled in the study, nine (9) in each group. Each participant will receive JNJ 10229570-AAA at 1.2%, 3.6% or vehicle in a cream formulation as a 2.5 mL application, to the face, neck, shoulders, chest and upper back areas. The investigational product will be washed off after the blood sampling at 24 hours after application. Safety and tolerability will be evaluated throughout the study and a topical dermatological assessment will be done by the dermatologists. The total duration of the study will be maximum 35 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne vulgaris, JNJ 10229570-AAA, Japanese patients, Topical treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JNJ 10229570-AAA 1.2%
Arm Type
Experimental
Arm Title
JNJ 10229570-AAA 3.6%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
JNJ 10229570-AAA 1.2%
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
JNJ 10229570-AAA 3.6%
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Color-matched vehicle containing 0 mg of JNJ 10229570-AAA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Topical Dermatological Assessment (Scores on Scales)
Description
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.
Time Frame
Days 1-7
Secondary Outcome Measure Information:
Title
Plasma M1 concentrations
Time Frame
12 time points up to 72 hours
Title
PK parameters
Description
PK parameters of JNJ-10229570-AAA, as measured by AUC, Cmax and tmax
Time Frame
12 time points up to 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Fukukoka
Country
Japan
City
Hakata
Country
Japan

12. IPD Sharing Statement

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A Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Participants With Acne Vulgaris

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