UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study on the safety and usefulness of Cyclodextrin inclusion welding Tretinoin for wrinkles and pigmentation of the skin
Title of the study (Brief title)	Clinical study on the safety and usefulness of Cyclodextrin inclusion welding Tretinoin for wrinkles and pigmentation of the skin
Region	Japan

Condition
Condition	Peoples who has wrinkles in an eye area or pigmentation.
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The tretinoin and the Cyclodextrin complex (CD Tretinoin Tretinoin) use test for 12 weeks. Comparative effects of skin irritation and pigmentation and wrinkles.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	<pigmentation> Degree of the pigmentation judged difference of the L * level of a pigmentation part and the normal part. <wrinkle> Degree of the right and left wrinkles judged in eight phases of wrinkle grade using an evaluation judgment table of the cosmetics industry society in Japan.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	I randomly assigned 0.025% tretinoin cream and 0.025% CD tretinoin cream to the half face of right and left. Once a day (at night:) I apply), 2 mg/cm2 (with a single face for none of the pearl grain sizes) to an aim after bathing.
Interventions/Control_2
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The person who is not treated for pigmentation and the wrinkle. Or the person whom there is more than 1 year after completion of treatment. The person that a symptom is stable by treatment as for the patient having a disease to become the factor of pigmentation or the wrinkle and complications. The person who has pigmentation or wrinkle on face among the staffs of the Tohoku University Hospital. Men and women over the age of 40 In the case of women, and people who can agree on contraception The person that I can judge participation in final examination or the nonparticipation, and a written agreement is provided in own
Key exclusion criteria	The person who has had a contact dermatitis by this study product ingredient and similar ingredient Person with exanthem unsuitable for the application part The person that the symptom of a disease and complications is not stable The person who is treated for pigmentation or the wrinkle.Or the person who does not pass more than one year. Younger than 40 years The person who cannot have an examination 2,4 and12 weeks later Women who do not agree with contraception. Women pregnant or nursing.
Target sample size	60

Research contact person
Name of lead principal investigator	Katsuko Kikuchi
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Dermatology
Address	Seiryo-machi 2-1, Aoba-ku, Sendai 980-8575, Japan
TEL
Email

Public contact
Name of contact person
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Dermatology
Address	Seiryo-machi 2-1, Aoba-ku, Sendai 980-8575, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	TOKIWA pharmaceutical Co.,Ltd.
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

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 27 Day
Anticipated trial start date	2013 Year 06 Month 01 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	2013 Year 04 Month 26 Day
Last modified on	2016 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012386