Healthy VolunteersPhase 1NCT01494714
A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Participants
A Phase 1 study testing JNJ 10229570-AAA 1.2% cream, JNJ 10229570-AAA 2.4% cream and JNJ 10229570-AAA 3.6% cream in people with Healthy Volunteers, run by Janssen Pharmaceutical K.K. at 2 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- JNJ 10229570-AAA 1.2% cream, JNJ 10229570-AAA 2.4% cream and JNJ 10229570-AAA 3.6% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesJapan
- Study dates
- Aug 2011to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- JNJ 10229570-AAA 1.2% cream, JNJ 10229570-AAA 2.4% cream, JNJ 10229570-AAA 3.6% cream, Color-matched vehicle in a cream formulation containing 0 mg of JNJ 10229570-AAA, Petroleum jelly
- Keywords
- Healthy volunteers, JNJ 10229570-AAA, Skin irritation, Skin photo irritation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ 10229570-AAA 1.2% creamDrug
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% creamDrug
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% creamDrug
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-AAADrug
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 jellyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Closed-patch test | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 72 hours
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)
Measured: 72 hours
Secondary outcomes (3)
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)
Measured: 72 hours
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)
Measured: 72 hours
Number of participants with adverse events as a measure of safety and tolerability
Measured: 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494714
- Sponsor's protocol ID
- CR018670
- Other IDs
- 10229570-JPN-01
- Status last verified
- Oct 2012
- First submitted
- 13 Dec 2011
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01494714
- Acronym / sponsor ID
- CR018670
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, JNJ 10229570-AAA, Skin irritation, Skin photo irritation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed-patch test | Experimental | 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ 10229570-AAA 1.2% creamA 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 | Closed-patch test |
| JNJ 10229570-AAA 2.4% creamA 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 | Closed-patch test |
| JNJ 10229570-AAA 3.6% creamA 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 | Closed-patch test |
| Color-matched vehicle in a cream formulation containing 0 mg of JNJ 10229570-AAAA 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 | Closed-patch test |
| Petroleum jellyA 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. | Drug | Closed-patch test |
Primary outcome
Skin irritation according to the Japanese evaluation criteria (scores on a scale)
Time frame: 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)
Skin photo irritation according to the Japanese evaluation criteria (scores on a scale)
Time frame: 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)
3 secondary outcomes
Skin irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale)
Time frame: 72 hours
Skin photo irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale)
Time frame: 72 hours
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 32 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutical K.K., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ 10229570-AAA 1.2% cream, JNJ 10229570-AAA 2.4% cream and JNJ 10229570-AAA 3.6% cream in people with Healthy Volunteers, run by Janssen Pharmaceutical K.K. at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin irritation according to the Japanese evaluation criteria (scores on a scale) (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.