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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023904
Receipt No. 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

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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
Email 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
Email m_kaneko@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027529

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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