A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Participants
30 oktober 2012 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
30
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Fukukoka, Japan
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Hakata, Japan
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 40 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Skin irritation according to the Japanese evaluation criteria (scores on a scale)
Tidsram: 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)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Skin irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale)
Tidsram: 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)
Tidsram: 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)
|
72 hours
|
|
Number of participants with adverse events as a measure of safety and tolerability
Tidsram: 32 days
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32 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2011
Primärt slutförande (Faktisk)
1 september 2011
Avslutad studie (Faktisk)
1 september 2011
Studieregistreringsdatum
Först inskickad
13 december 2011
Först inskickad som uppfyllde QC-kriterierna
15 december 2011
Första postat (Uppskatta)
19 december 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
31 oktober 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 oktober 2012
Senast verifierad
1 oktober 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR018670
- 10229570-JPN-01 (Annan identifierare: Janssen Pharmaceutical K.K., Japan)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .