UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018677 |
|---|---|
| Receipt number | R000021599 |
| Scientific Title | Investigation of the efficacy of read-through therapy for Nagashima-type palmoplantar keratosis using topical aminoglycoside |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2018/02/14 14:08:06 |
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Basic information
Public title
Investigation of the efficacy of read-through therapy for Nagashima-type palmoplantar keratosis using topical aminoglycoside
Acronym
Read-through therapy for Nagashima-type palmoplantar keratosis
Scientific Title
Investigation of the efficacy of read-through therapy for Nagashima-type palmoplantar keratosis using topical aminoglycoside
Scientific Title:Acronym
Read-through therapy for Nagashima-type palmoplantar keratosis
Region
| Japan |
Condition
Condition
Nagashima-type palmoplantar keratosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We investigate the efficacy of read-through therapy using 0.1% gentamicin ointment in patients with NPPK.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Improvement of skin symptoms such as erythema and hyperkeratosis.
2.Participants' self-assessment of improvement by VAS (Visual Analogue Scale).
We evaluate skin symptoms 4 weeks after the treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients apply vaseline or 0.1% gentamicin topically to one of the hands with erythema and hyperkeratosis twice a day for 4 weeks.
Interventions/Control_2
The patients apply vaseline or 0.1% gentamicin topically to one of the hands with erythema and hyperkeratosis twice a day for 4 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
NPPK patients at the Hokkaido University hospital who fulfill the following criteria:
1.Patients aged 1 or older at the time of informed consent.
2.Patients who are homozygous or heterozygous for the mutation c.796C>T in SERPINB7.
3.Patients showing erythema and hyperkeratosis on both hands.
4.Patients giving written informed consent.
Key exclusion criteria
1.Patients who meet exclusion criteria of the drug.
2.Patients with severe complications who need hospitalization.
3.Patients who is considered to be inappropriate for this study.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshifumi Nomura |
Organization
Hokkaido University Hospital
Division name
Department of Dermatology
Zip code
Address
North 14 West 5, Kita-ku, Sapporo 060-8648, Japan
TEL
011-716-1161
nomura@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Ohguchi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
North 15 West 7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-706-7387
Homepage URL
yu-ohguchi@keb.biglobe.ne.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2015 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | 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
| 2015 | Year | 08 | Month | 14 | Day |
Last modified on
| 2018 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021599
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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