UMIN-CTR Clinical Trial

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
Last 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
Email	dermatol@med.kobe-u.ac.jp

Public contact
1st 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
Email	atsushi@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine(Kobe University Hospital)
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018191