A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Participants
30. oktober 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Fukukoka, Japan
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Hakata, Japan
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 40 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Closed-patch test
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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.
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.
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.
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.
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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)
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72 hours
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Skin photo irritation according to the Japanese evaluation criteria (scores on a scale)
Tidsramme: 72 hours
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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)
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72 hours
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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)
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72 hours
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Skin photo irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale)
Tidsramme: 72 hours
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The ICDRG scale measures the level of skin irritation from Negative (no reaction) to Extreme Positive Reaction (erythema, infiltration, confluent vesicles)
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72 hours
|
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Number of participants with adverse events as a measure of safety and tolerability
Tidsramme: 32 days
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32 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2011
Primær fullføring (Faktiske)
1. september 2011
Studiet fullført (Faktiske)
1. september 2011
Datoer for studieregistrering
Først innsendt
13. desember 2011
Først innsendt som oppfylte QC-kriteriene
15. desember 2011
Først lagt ut (Anslag)
19. desember 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
31. oktober 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. oktober 2012
Sist bekreftet
1. oktober 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR018670
- 10229570-JPN-01 (Annen identifikator: Janssen Pharmaceutical K.K., Japan)
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