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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012355
Receipt No. R000014445
Scientific Title Treatment of the genetic defect of cholesterol biosynthetic pathway by the topical application of statin and cholesterol
Date of disclosure of the study information 2013/11/19
Last modified on 2020/11/24

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Basic information
Public title Treatment of the genetic defect of cholesterol biosynthetic pathway by the topical application of statin and cholesterol
Acronym Treatment of the genetic defect of cholesterol biosynthetic pathway
Scientific Title Treatment of the genetic defect of cholesterol biosynthetic pathway by the topical application of statin and cholesterol
Scientific Title:Acronym Treatment of the genetic defect of cholesterol biosynthetic pathway
Region
Japan

Condition
Condition CHILD syndrome
Conradi-Hunermann-Happle syndrome
Atopic dermatitis
Psoriasis vulgaris
Seborrheic dermatitis
Porokeratosis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Treatment of skin manifestations
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of skin erythema and scales
Key secondary outcomes

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% atorvastatin/ 2% cholesterol
Topical application of oxiconazole cream
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
1 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria Patients of CHILD syndrome or Conradi syndrome confirmed by genetic diagnosis
Patients of atopic dermatitis, psoriasis vulgaris, seborrheic dermatitis, and porokeratosis diagnosed clinically.
Key exclusion criteria Patients without skin manifestations
Target sample size 148

Research contact person
Name of lead principal investigator
1st name Akiharu
Middle name
Last name Kubo
Organization Keio University School of Medicine
Division name Department of Dermatology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku
TEL 03-3353-1211
Email akiharu@a5.keio.jp

Public contact
Name of contact person
1st name Akiharu
Middle name
Last name Kubo
Organization Keio University School of Medicine
Division name Department of Dermatology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku
TEL 03-3353-1211
Homepage URL
Email akiharu@a5.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 Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Keio University Hospital CRB
Address 35 Shinanomachi Shinjuku, Tokyo
Tel 03-5363-3503
Email akihiro.mitsunaga@adst.keio.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 慶應義塾大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 19 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 21
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 No longer recruiting
Date of protocol fixation
2013 Year 03 Month 25 Day
Date of IRB
2013 Year 03 Month 25 Day
Anticipated trial start date
2013 Year 11 Month 20 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 19 Day
Last modified on
2020 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014445

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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