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

30. oktober 2012 opdateret af: Janssen Pharmaceutical K.K.

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
      • Fukukoka, Japan
      • Hakata, Japan

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Closed-patch test
Medicin: 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.
Medicin: 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.
Medicin: 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.
Medicin: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Skin irritation according to the Japanese evaluation criteria (scores on a scale)
Tidsramme: 72 hours
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
Skin photo irritation according to the Japanese evaluation criteria (scores on a scale)
Tidsramme: 72 hours
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Skin irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale)
Tidsramme: 72 hours
The ICDRG scale measures the level of skin irritation from Negative (no reaction) to Extreme Positive Reaction (erythema, infiltration, confluent vesicles)
72 hours
Skin photo irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale)
Tidsramme: 72 hours
The ICDRG scale measures the level of skin irritation from Negative (no reaction) to Extreme Positive Reaction (erythema, infiltration, confluent vesicles)
72 hours
Number of participants with adverse events as a measure of safety and tolerability
Tidsramme: 32 days
32 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Pharmaceutical K.K.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2011

Primær færdiggørelse (Faktiske)

1. september 2011

Studieafslutning (Faktiske)

1. september 2011

Datoer for studieregistrering

Først indsendt

13. december 2011

Først indsendt, der opfyldte QC-kriterier

15. december 2011

Først opslået (Skøn)

19. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR018670
  • 10229570-JPN-01 (Anden identifikator: Janssen Pharmaceutical K.K., Japan)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med JNJ 10229570-AAA 1.2% cream

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Dominican Republic

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner