UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018986 |
|---|---|
| Receipt number | R000021959 |
| Scientific Title | Examination of usefulness and safety of heparinoid agent based external medicine (over counter drug) for facial dryness symptom. |
| Date of disclosure of the study information | 2015/09/30 |
| Last modified on | 2018/10/04 19:45:37 |
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Basic information
Public title
Examination of usefulness and safety of heparinoid agent based external medicine (over counter drug) for facial dryness symptom.
Acronym
Usefulness of heparinoid agent based external medicine for facial dryness symptom.
Scientific Title
Examination of usefulness and safety of heparinoid agent based external medicine (over counter drug) for facial dryness symptom.
Scientific Title:Acronym
Usefulness of heparinoid agent based external medicine for facial dryness symptom.
Region
| Japan |
Condition
Condition
facial dryness symptom
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of usefulness and safety of heparinoid agent based external medicine (over counter drug) for facial dryness symptom.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
At the time of strating, 2 weeks later and 4 weeks later.
The measurement of
a. Wrinkle and pigmented spot.
b. Moisture content of the stratum corneum.
c. Transepidermal water loss.
d. Skin elasticity.
e. Tape stripping of corneocyte.
Key secondary outcomes
Change of the subjective symptoms of the subject.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Test medicine is used for right face, and placebo medicine is used for left face, for 4 weeks twice a day.
Interventions/Control_2
Placebo medicine is used for right face, and test medicine is used for left face, for 4 weeks twice a day.
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
The person who fells facail dryness symptom.
Key exclusion criteria
The person
1. Who takes in an oral pharmaceutical product or a supplement which may affect the skin condition habitually.
2. Who had the anamnestic history of surgical operation on the testing area.
3. Who is infected with hemorrhagic disease.
4. Who has skin rash of atopic dermatitis on face.
5. Who uses regularly an external medicine.
6. Who had the anamnesis of heparinoid allergy.
7. Who has allergy or sensitivity to drug and cosmetics.
8. Who can not agree that using same cosmetics all over the study time.
9. Who has skin disease on the testing area.
10. Who has the factor on the testing area which may affect the result.
11. Who has critical illness of glucose metabolism, lipid metabolism, liver function, renal function, cardiovascular system, respiratory tract, endocrine system, immune system and nervous system, or had the anamnestic history of psychiatric disorder.
12. Who can not understand about examination contents.
13. Who is pregnant or lactating.
14. Who is impossible to come to the testing institution on an examination day.
15. Who participates in other examinations.
16. Who is recognized to be inappropriate as a subject by attending physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Tsuruta |
Organization
Osaka city university graduate school of medicine
Division name
department of dermatology
Zip code
Address
1-4-3 Asahimachi Abeno-ku Osaka
TEL
06-6645-3826
dtsuruta@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Tsuruta |
Organization
Osaka city university graduate school of medicine
Division name
department of dermatology
Zip code
Address
1-4-3 Asahimachi Abeno-ku Osaka
TEL
06-6645-3826
Homepage URL
dtsuruta@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka city university graduate school of medicine, department of dermatology
Institute
Department
Personal name
Funding Source
Organization
Kobayashi pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nikoderm research Inc., CIEL Co., Ltd.
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
株式会社ニコダームリサーチ(大阪府）Nikoderm research Inc. (Osaka-fu)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 30 | 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
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 | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 24 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 11 | Day |
Last modified on
| 2018 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021959
| Research Plan | |
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| Registered date | File name |
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