UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety and usability assessment of sunscreen agents (cosmetics) for light-sensitive patients
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yoshiki Miyachi
Organization	Kyoto University Hospital
Division name	Department of Dermatology
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	Akihiro Fujisawa
Organization	Kyoto University Hospital
Division name	Department of Dermatology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015000