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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01494714
First received: December 13, 2011
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: JNJ 10229570-AAA 1.2% cream
Drug: JNJ 10229570-AAA 2.4% cream
Drug: JNJ 10229570-AAA 3.6% cream
Drug: Color-matched vehicle in a cream formulation containing 0 mg of JNJ 10229570-AAA
Drug: Petroleum jelly
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Skin irritation according to the Japanese evaluation criteria (scores on a scale) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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)

  • Skin photo irritation according to the Japanese evaluation criteria (scores on a scale) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Skin irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    The ICDRG scale measures the level of skin irritation from Negative (no reaction) to Extreme Positive Reaction (erythema, infiltration, confluent vesicles)

  • Skin photo irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    The ICDRG scale measures the level of skin irritation from Negative (no reaction) to Extreme Positive Reaction (erythema, infiltration, confluent vesicles)

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 32 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Closed-patch test 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.
Drug: 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.
Drug: 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.
Drug: 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.
Drug: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494714

Locations
Japan
Fukukoka, Japan
Hakata, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01494714     History of Changes
Other Study ID Numbers: CR018670, 10229570-JPN-01
Study First Received: December 13, 2011
Last Updated: October 30, 2012
Health Authority: Japan: Pharmaceuticals and Devices Agency

Keywords provided by Janssen Pharmaceutical K.K.:
Healthy volunteers
JNJ 10229570-AAA
Skin irritation
Skin photo irritation

Additional relevant MeSH terms:
Petrolatum
Dermatologic Agents
Emollients
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014