A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Participants

Healthy Volunteers Clinical Trial

Official title:

A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494714
• Other study ID #: CR018670
• Secondary ID: 10229570-JPN-01
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2011
• Last updated: October 30, 2012
• Start date: August 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2012
• 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 skin irritation and photo irritation of JNJ 10229570-AAA on intact skin of Japanese healthy male participants.

Description:

This is a single center, interpreter-blinded (the person interpreting the results does not know the name of the assigned drug), randomized (drug is assigned by chance like flipping a coin), vehicle-controlled, closed-patch test study. Thirty (30) Japanese participants will be enrolled in the study. Each treatment (JNJ 10229570-AAA at 1.2%, 2.4%, 3.6%, vehicle in a cream formulation, and petroleum jelly) will be randomly applied in vertical position on the back of each participant, with a corresponding strength applied at the same vertical position (left vs. right). The study drugs applied on the left side will be washed off at 48 hours after application. The dermatological evaluation and photo shoots will be done at 1 (T49) and 24 (T72) hours after washing off the drugs. All participants who completed the dermatological evaluation will be included in the evaluation of skin irritation and skin photo irritation. The study drugs applied on the right side will be washed off at 24 hours after application. The dermatological evaluation and photo shoots will be done at 1 hour after washing off. Ultraviolet A (UVA) will be irradiated to the application site. One hour after irradiation start (T26), the dermatological evaluation and photo shoots will be done. Afterwards the application site will be covered for the protection against UV. Twenty-four hours after washing off (T48), the cover will be taken off, and then the dermatological evaluation and photo shoots will be done at 1 (T49) and 24 (T72) hours. Additionally, the safety profile of JNJ 10229570-AAA will be assessed during the study. The study has a total duration of maximum 32 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Signed an informed consent document

• Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg

• 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

• Agree to use an adequate contraception method

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 (including vitamins and herbal supplements) 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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• JNJ 10229570-AAA 1.2% cream
A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
• JNJ 10229570-AAA 2.4% cream
A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
• JNJ 10229570-AAA 3.6% cream
A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
• Color-matched vehicle in a cream formulation containing 0 mg of JNJ 10229570-AAA
A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
• Petroleum jelly
A patch containing the petroleum jelly will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.

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	Skin irritation according to the Japanese evaluation criteria (scores on a scale)	The Japanese skin irritation evaluation criteria is a 6-point scale specifying the irritation level of the skin, from 0 (no response) to 4 (blister)	72 hours	No
Primary	Skin photo irritation according to the Japanese evaluation criteria (scores on a scale)	The Japanese skin photo irritation evaluation criteria is a 6-point scale specifying the level of skin photo irritation from 0 (lack of reaction or reaction comparable to non-irradiated site) to 4 (reaction four ranks more pronouced using domestic criteria compared with non-irradiated site)	72 hours	No
Secondary	Skin irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale)	The ICDRG scale measures the level of skin irritation from Negative (no reaction) to Extreme Positive Reaction (erythema, infiltration, confluent vesicles)	72 hours	No
Secondary	Skin photo irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale)	The ICDRG scale measures the level of skin irritation from Negative (no reaction) to Extreme Positive Reaction (erythema, infiltration, confluent vesicles)	72 hours	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability		32 days	No