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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012841
Receipt No. R000015000
Scientific Title The safety and usability assessment of sunscreen agents (cosmetics) for light-sensitive patients
Date of disclosure of the study information 2014/03/01
Last modified on 2016/07/13

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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 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Miyachi
Organization Kyoto University Hospital
Division name Department of Dermatology
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-ku,Kyoto, 6068507, Japan
TEL 075-751-3111
Email hifuka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Fujisawa
Organization Kyoto University Hospital
Division name Department of Dermatology
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-ku,Kyoto, 6068507, Japan
TEL 075-751-3111
Homepage URL
Email fujiaki@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Dermatology, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization TOKIWA Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 03 Month 01 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
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 01 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 13 Day
Last modified on
2016 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015000

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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