UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015646 |
|---|---|
| Receipt number | R000018191 |
| Scientific Title | The safety and usability assessment of sunscreen agents (cosmetics) for light-sensitive patients |
| Date of disclosure of the study information | 2014/11/10 |
| Last modified on | 2019/03/31 12:00:55 |
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Basic information
Public title
The safety and usability assessment of sunscreen agents (cosmetics) for light-sensitive patients
Acronym
The safety and usability assessment of sunscreen agents
Scientific Title
The safety and usability assessment of sunscreen agents (cosmetics) for light-sensitive patients
Scientific Title:Acronym
The safety and usability assessment of sunscreen agents
Region
| Japan |
Condition
Condition
Light-sensitive patients including such as xeroderma pigmentosum, chronic actinic dermatitis, photosensitivity dermatitis, drug-induced photosensitivity
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Veridation of the safety(10% or less rate of adverse effect) and usability in light-sensitive patients by applying sunscreen agents to sun-exposure area of the light-sensitive patients for 4 weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the safety(10% or less rate of adverse effect
Key secondary outcomes
the usability(the changes of skin findings and cytokines in the stratum corneum)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Applying sunscreen agents to sun-exposure area of light-sensitive patients for 4 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients diagnosed with photosensitivity, who is determined that the use of this reserch article is useful therapeutically
2.Regardless of age or sex
3.Patients (whose legal representative in the case of minors) are in agreement
In addition, we define photosensitivity as follows in this study.
1.photosensitivity disease including such as xeroderma pigmentosum, chronic actinic dermatitis, photosensitivity dermatitis,drug-induced photosensitivity
2.the diseases exacerbated by sun exposure including such as systemic lupus erythematosus, discoid lupus erythematosus, subacute cutaneous lupus erythematosus, dermatomyositis, rosacea-like dermatitis, Sjogren's syndrome
3.the diseases which is desirable to avoid sun exposure therapeutically for in improving disease, including atopic dermatitis, pigment spots (such as after laser treatment).
Key exclusion criteria
1.Those who have experience with the use of sunscreen agents, resulted in a skin severe symptoms in the past.
2.Those who have skin eruption on the application area of this research article.
3.The case that the interference of this reserch article and other topical product
is expected.
4.Pregnant or nursing women
5.Those who can not (in principle) be examined after 4 weeks
6.Those who are deemed inappropriate to participate in this study by doctor.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Nishigori |
| Middle name | |
| Last name | Chikako |
Organization
Kobe University Graduate School of Medicine(Kobe University Hospital)
Division name
Department of Dermatology,
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku,
TEL
078-382-6134
dermatol@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Fukunaga |
| Middle name | |
| Last name | Atsushi |
Organization
Kobe University Graduate School of Medicine(Kobe University Hospital)
Division name
Department of Dermatology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6134
Homepage URL
atsushi@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine(Kobe University Hospital)
Institute
Department
Personal name
Funding Source
Organization
TOKIWA Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe University Graduate School of Medicine(Kobe University Hospital)
Department of Dermatology, Hokkaido University Graduate School of Medicine(Hokkaido University Hospital)
Graduate School of Medicine, Kyoto University(Kyoto University Hospital)
Kyushu University, Graduate School of Medical Sciences(Kyushu University Hospital)
Faculty of life science, Kumamoto University(Kumamoto University Hospital)
Kanagawa Chirdren's Medicalcenter
Rikako's Clinic of Dermatology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KOBE Univ. Hosp. CRB
Address
7-5-2 kusunoki-cho chuo-ku Kobe Japan
Tel
078-382-6669
cerb@med.kobe-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
31
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 10 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018191
