Healthy VolunteerPhase 1NCT05245578
Safety Evaluation of KX01 Ointment 1% in Japanese Healthy Male Subjects
A Phase 1 study testing KX01 ointment 1% in people with Healthy Volunteer, run by PharmaEssentia at 1 site in Japan.
Trial summary
Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese healthy male subjects Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- KX01 ointment 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- 16 Nov 2021to 12 Jan 2022
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Japanese male adult, whose age 20-65 years old
Who cannot join
- History of photosensitivity or photoallergy
Trial locations and contacts
1 site in 1 country.
Japan1 site
Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic
Toshima-ku, Tokyo, 171-0014
About this study
Official title: Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese Healthy Male Subjects
Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese healthy male subjects
Read the detailed description
A baseline evaluation of the patch sites will be performed immediately prior to application of the patches to ensure that no conditions, markings, or coloration of the skin will interfere with interpretation of the study results.
A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01KX2-391 ointment 1% and 2 sites for Placebo vehicle ointment. One set (KX01 ointment 1% IP and Placebo ointment vehicle patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions. The distance between the patches will be no less than one centimeter.
The numbering of the test sites will remain the same throughout the study. The sites will be marked with an indelible, surgical marker.
- Conditions
- Healthy Volunteer
- Being tested
- KX01 ointment 1%, Placebo ointment
- Keywords
- Skin Irritation, Phototoxicity
- Medical subject headings
- Dermatitis, Phototoxic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KX01 ointment 1%Drug
A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01 ointment 1% and 2 sites for Placebo ointment. One set (KX01 ointment 1% and Placebo ointment patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions.
Placebo ointmentDrug
A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01 ointment 1% and 2 sites for Placebo ointment. One set (KX01 ointment 1% and Placebo ointment patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions.
| Study group | Role | What they receive |
|---|---|---|
| KX01 ointment and Placebo ointment | Experimental | Not described Receives: Drug: KX01 ointment 1%; Drug: Placebo ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of skin irritation at application site
Degree of skin irritation will be evaluated according to the criteria (response scores and response notations). The same evaluator, if possible, should perform the assessment throughout the study.
Measured: 9 days
Phototoxic potential at application site
Phototoxic potential will be evaluated according to the criteria (response scores and response notations). The same evaluator, if possible, should perform the assessment throughout the study.
Measured: 9 days
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start16 Nov 2021
- Primary completion22 Nov 2021
- Study completion12 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaEssentia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaEssentia Japan K.K.
- Responsible party
- Sponsor
- Investigators
- Hisakuni Sekino, Principal investigator, Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245578
- Sponsor's protocol ID
- B21-101
- Status last verified
- Feb 2022
- First submitted
- 30 Dec 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05245578
- Acronym / sponsor ID
- B21-101
- Conditions
- Healthy Volunteer
- Keywords
- Skin Irritation, Phototoxicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PharmaEssentiaIndustry (pharma, biotech, devices)
- Collaborators
- PharmaEssentia Japan K.K.
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 18 Feb 2022 (actual)
- 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.
Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese healthy male subjects
Detailed description
A baseline evaluation of the patch sites will be performed immediately prior to application of the patches to ensure that no conditions, markings, or coloration of the skin will interfere with interpretation of the study results.
A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01KX2-391 ointment 1% and 2 sites for Placebo vehicle ointment. One set (KX01 ointment 1% IP and Placebo ointment vehicle patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions. The distance between the patches will be no less than one centimeter.
The numbering of the test sites will remain the same throughout the study. The sites will be marked with an indelible, surgical marker.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KX01 ointment and Placebo ointment | Experimental | Drug: KX01 ointment 1%, Drug: Placebo ointment |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Japanese male adult, whose age 20-65 years old
Key exclusion criteria (1 listed)
- History of photosensitivity or photoallergy
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 |
|---|---|---|
| KX01 ointment 1%A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01 ointment 1% and 2 sites for Placebo ointment. One set (KX01 ointment 1% and Placebo ointment patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions. | Drug | KX01 ointment and Placebo ointment |
| Placebo ointmentA total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01 ointment 1% and 2 sites for Placebo ointment. One set (KX01 ointment 1% and Placebo ointment patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions. | Drug | KX01 ointment and Placebo ointment |
Primary outcome
Degree of skin irritation at application site
Time frame: 9 days
Degree of skin irritation will be evaluated according to the criteria (response scores and response notations). The same evaluator, if possible, should perform the assessment throughout the study.
Phototoxic potential at application site
Time frame: 9 days
Phototoxic potential will be evaluated according to the criteria (response scores and response notations). The same evaluator, if possible, should perform the assessment throughout the study.
1 secondary outcome
Number of participants with adverse events as a measure of safety
Time frame: 9 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 18 Feb 2022.
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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.
Hisakuni Sekino principal investigator
Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KX01 ointment 1% in people with Healthy Volunteer, run by PharmaEssentia at 1 site 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 1 inclusion and 1 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 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Degree of skin irritation at application site (time frame: 9 days). 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 18 Feb 2022.