UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023904 |
|---|---|
| Receipt number | R000027529 |
| Scientific Title | A clinical trial of the external preparations on the keratosis patients. |
| Date of disclosure of the study information | 2016/09/27 |
| Last modified on | 2017/03/06 11:27:36 |
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Basic information
Public title
A clinical trial of the external preparations on the keratosis patients.
Acronym
A clinical trial of the external preparations on the keratosis patients.
Scientific Title
A clinical trial of the external preparations on the keratosis patients.
Scientific Title:Acronym
A clinical trial of the external preparations on the keratosis patients.
Region
| Japan |
Condition
Condition
Keratosis
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the clinical efficacy and safety of topical external preparations in the treatment of keratosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy (keratosis and wrinkle grade) and safety assessment of the test samples by the principal investigator or the sub-investigator before and after the four- and the eight-week application.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Apply topical prescribed drug for keratosis twice a day for 8 weeks.
Interventions/Control_2
Apply topical comparator product twice a day for 8 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
| 50 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Japanese.
2) The persons who have dry and/or stiff feeling in the facial skin.
3) The persons who can peel off the goods for double eyelid at the time.
4) The persons who do not mind the base material and/or solvents adhere to the eyelashes at the time of the replica picking (, if the patients with eyelash extensions).
5) The persons with tending to stay indoors and who have no plans to go out (travel, business trip, etc) during the test period.
6) The persons who agree with the joining this study based on the consent by the document.
7) Patients with some keratosis on the test site (Corner of the eye and lower eyelid) that was diagnosed by the principal investigator or the sub-investigator.
8) Patients who do not have scratches, warts, pimples or burns on the test site, which might have negative impact in the evaluation and measurement.
9) Patients who have wrinkles on the test site, which belongs to the grade 3 to 6 ("Evaluation guidelines for the new efficacy acquisition of Anti-wrinkle product" published by Japanese cosmetic science society).
10) Patients who have the wrinkles belonging to similar grade in the left and right on the test site.
Key exclusion criteria
1) Patients with history of allergy to cosmetics.
2) Patients who are receiving hormone replacement therapy.
3) Patients with experience of cosmetic medicine that might have negative impact on the test site.
4) Patients who are being treated with dermatology.
5) Pregnant or lactating patients. Patients with suspicion of pregnancy.
6) Patients who are participating in other clinical trials
7) Patients deemed inappropriate to participate in this study by the principal investigator or the sub-investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Koikeda |
Organization
Shiba Palace Clinic
Division name
Chief of Clinic
Zip code
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1599
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miwa Kaneko |
Organization
SOUKEN CO., LTD
Division name
Secretariat
Zip code
Address
DaiwaA Hamamatsucho Bldg. 5F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1557
Homepage URL
m_kaneko@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
芝パレスクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 27 | 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
| 2016 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 28 | 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
| 2016 | Year | 09 | Month | 02 | Day |
Last modified on
| 2017 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027529
