Acne VulgarisPhase 1NCT01492647
A Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Participants With Acne Vulgaris
A Phase 1 study testing JNJ 10229570-AAA 1.2% and JNJ 10229570-AAA 3.6% in people with Acne Vulgaris, run by Janssen Pharmaceutical K.K. at 2 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of JNJ 10229570-AAA after a single topical application of JNJ 10229570-AAA 1.2% and 3.6% cream in Japanese participants with acne. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- JNJ 10229570-AAA 1.2% and JNJ 10229570-AAA 3.6%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesJapan
- Study dates
- Aug 2011to Oct 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have Acne vulgaris, presenting at least inflammatory lesion on the face
- Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg (man) or 45 kg (woman)
- 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
- Adequate contraception method for both men and women. If a woman, must have a negative pregnancy test
- Signed an informed consent document
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 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
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- 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 Randomized, Double Blinded, Single Topical Dose Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Subjects With Acne Vulgaris
The purpose of this study is to evaluate the safety and tolerability of JNJ 10229570-AAA after a single topical application of JNJ 10229570-AAA 1.2% and 3.6% cream in Japanese participants with acne.
Read the detailed description
This is a randomized (drug assigned by chance like flipping a coin), double blinded (neither physician nor patient knows the name of the assigned drug), single dose ascending study of JNJ 10229570-AAA in Japanese participants with acne. The study will evaluate the safety and pharmacokinetics ([PK] how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) of M1 (active metabolite) in a total of eighteen (18) participants enrolled in the study, nine (9) in each group. Each participant will receive JNJ 10229570-AAA at 1.2%, 3.6% or vehicle in a cream formulation as a 2.5 mL application, to the face, neck, shoulders, chest and upper back areas. The investigational product will be washed off after the blood sampling at 24 hours after application. Safety and tolerability will be evaluated throughout the study and a topical dermatological assessment will be done by the dermatologists. The total duration of the study will be maximum 35 days.
- Conditions
- Acne Vulgaris
- Being tested
- JNJ 10229570-AAA 1.2%, JNJ 10229570-AAA 3.6%, Color-matched vehicle containing 0 mg of JNJ 10229570-AAA
- Keywords
- Acne vulgaris, JNJ 10229570-AAA, Japanese patients, Topical treatment
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ 10229570-AAA 1.2%Drug
One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas.
JNJ 10229570-AAA 3.6%Drug
One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas.
Color-matched vehicle containing 0 mg of JNJ 10229570-AAADrug
One single application of 2.5 mL of the color-matched vehicle will be applied to the face, neck, shoulders, chest and to the upper back areas.
| Study group | Role | What they receive |
|---|---|---|
| JNJ 10229570-AAA 1.2% | Experimental | Not described Receives: Drug: JNJ 10229570-AAA 1.2%; Drug: Color-matched vehicle containing 0 mg of JNJ 10229570-AAA |
| JNJ 10229570-AAA 3.6% | Experimental | Not described Receives: Drug: JNJ 10229570-AAA 3.6%; Drug: Color-matched vehicle containing 0 mg of JNJ 10229570-AAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Topical Dermatological Assessment (Scores on Scales)
The Topical Dermatological Assessment is based on the 3 to 4-point Cutaneous Irritation Grading Scales that assess the level of Erythema, Dryness, Peeling/Scaling, Burning/Stinging, and Itching from 0 (no reaction) to 3 or 4 (strong reaction). In addition, the assessment observes and records any pigmentation change that may occur on the skin after the intervention.
Measured: Days 1-7
Secondary outcomes (2)
Plasma M1 concentrations
Measured: 12 time points up to 72 hours
PK parameters
PK parameters of JNJ-10229570-AAA, as measured by AUC, Cmax and tmax
Measured: 12 time points up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 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
- NCT01492647
- Sponsor's protocol ID
- CR018673
- Other IDs
- 10229570-JPN-02
- Status last verified
- Feb 2013
- First submitted
- 13 Dec 2011
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded, Single Topical Dose Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01492647
- Acronym / sponsor ID
- CR018673
- Conditions
- Acne Vulgaris
- Keywords
- Acne vulgaris, JNJ 10229570-AAA, Japanese patients, Topical treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 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 the safety and tolerability of JNJ 10229570-AAA after a single topical application of JNJ 10229570-AAA 1.2% and 3.6% cream in Japanese participants with acne.
Detailed description
This is a randomized (drug assigned by chance like flipping a coin), double blinded (neither physician nor patient knows the name of the assigned drug), single dose ascending study of JNJ 10229570-AAA in Japanese participants with acne. The study will evaluate the safety and pharmacokinetics ([PK] how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) of M1 (active metabolite) in a total of eighteen (18) participants enrolled in the study, nine (9) in each group. Each participant will receive JNJ 10229570-AAA at 1.2%, 3.6% or vehicle in a cream formulation as a 2.5 mL application, to the face, neck, shoulders, chest and upper back areas. The investigational product will be washed off after the blood sampling at 24 hours after application. Safety and tolerability will be evaluated throughout the study and a topical dermatological assessment will be done by the dermatologists. The total duration of the study will be maximum 35 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNJ 10229570-AAA 1.2% | Experimental | Drug: JNJ 10229570-AAA 1.2%, Drug: Color-matched vehicle containing 0 mg of JNJ 10229570-AAA |
| JNJ 10229570-AAA 3.6% | Experimental | Drug: JNJ 10229570-AAA 3.6%, Drug: Color-matched vehicle containing 0 mg of JNJ 10229570-AAA |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Have Acne vulgaris, presenting at least inflammatory lesion on the face
- Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg (man) or 45 kg (woman)
- 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 (10 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 within 14 days before the study treatment
- History of drug or alcohol abuse within the past 5 years
- Drug allergy or drug hypersensitivity
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%One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas. | Drug | JNJ 10229570-AAA 1.2% |
| JNJ 10229570-AAA 3.6%One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas. | Drug | JNJ 10229570-AAA 3.6% |
| Color-matched vehicle containing 0 mg of JNJ 10229570-AAAOne single application of 2.5 mL of the color-matched vehicle will be applied to the face, neck, shoulders, chest and to the upper back areas. | Drug | JNJ 10229570-AAA 1.2%, JNJ 10229570-AAA 3.6% |
Primary outcome
Topical Dermatological Assessment (Scores on Scales)
Time frame: Days 1-7
The Topical Dermatological Assessment is based on the 3 to 4-point Cutaneous Irritation Grading Scales that assess the level of Erythema, Dryness, Peeling/Scaling, Burning/Stinging, and Itching from 0 (no reaction) to 3 or 4 (strong reaction). In addition, the assessment observes and records any pigmentation change that may occur on the skin after the intervention.
2 secondary outcomes
Plasma M1 concentrations
Time frame: 12 time points up to 72 hours
PK parameters
Time frame: 12 time points up to 72 hours
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 20 Feb 2013.
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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% and JNJ 10229570-AAA 3.6% in people with Acne Vulgaris, 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 7 inclusion and 10 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 20 Feb 2013. 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?
Topical Dermatological Assessment (Scores on Scales) (time frame: Days 1-7). 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 20 Feb 2013; AzTrials last refreshed its copy on 7 Nov 2026.