UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical trial of the external preparations on the keratosis patients.
Title of the study (Brief title)	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	Takashi Koikeda
Organization	Shiba Palace Clinic
Division name	Chief of Clinic
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	Miwa Kaneko
Organization	SOUKEN CO., LTD
Division name	Secretariat
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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