UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment of the skin manifestations of Darier's disease by the topical application of COX-2 inhibitors
Title of the study (Brief title)	Treatment of Darier's disease by the topical application of COX-2 inhibitors
Region	Japan

Condition
Condition	Darier's disease
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Therapy and safety evaluation of the topical COX-2 inhibitor treatment on the skin manifestations of Darier's disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of skin manifestations which are evaluated by Psoriasis Area and Severity Index score after 3-month treatment
Key secondary outcomes	Safety evaluation: Common terminology criteria for adverse events v4.0 grade 3-5 Therapy evaluation: Pathological findings and level of expression of ATP2A2 after 3-month treatment

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Topical application of 1% diclofenac sodium gel
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients of Darier's disease diagnosed by clinical manifestation and pathological finding
Key exclusion criteria	1) Patients without disease notification 2) Patients who do not join "Development of the genetic diagnosis system of congenital and Inherited skin disorders (UMIN000009851)" 3) Aspirin-induced asthma patients 4) Patients with diclofenac sodium allergy 5) Pregnant women
Target sample size	10

Research contact person
Name of lead principal investigator	Akiharu Kubo
Organization	Keio University School of Medicine
Division name	Department of Dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	akiharu@keio.jp

Public contact
Name of contact person	Akiharu Kubo
Organization	Keio University School of Medicine
Division name	Department of Dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	akiharu@keio.jp

Sponsor
Institute	Department of Dermatology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Department of Dermatology, Keio University School of Medicine
Organization
Division
Category of Funding Organization	Other
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	慶應義塾大学医学部（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 25 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 11 Month 28 Day
Anticipated trial start date	2014 Year 12 Month 25 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 12 Month 10 Day
Last modified on	2018 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018482