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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492647
• Other study ID #: CR018673
• Secondary ID: 10229570-JPN-02
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2011
• Last updated: February 18, 2013
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: February 2013
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Plasma M1 concentrations		12 time points up to 72 hours	No
Secondary	PK parameters	PK parameters of JNJ-10229570-AAA, as measured by AUC, Cmax and tmax	12 time points up to 72 hours	No