UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010597
Receipt No. R000012386
Scientific Title Clinical study on the safety and usefulness of Cyclodextrin inclusion welding Tretinoin for wrinkles and pigmentation of the skin
Date of disclosure of the study information 2013/04/27
Last modified on 2016/10/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical study on the safety and usefulness of Cyclodextrin inclusion welding Tretinoin for wrinkles and pigmentation of the skin
Acronym Clinical study on the safety and usefulness of Cyclodextrin inclusion welding Tretinoin for wrinkles and pigmentation of the skin
Scientific Title Clinical study on the safety and usefulness of Cyclodextrin inclusion welding Tretinoin for wrinkles and pigmentation of the skin
Scientific Title:Acronym 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
1st name
Middle name
Last name Katsuko Kikuchi
Organization Tohoku University Graduate School of Medicine
Division name Department of Dermatology
Zip code
Address Seiryo-machi 2-1, Aoba-ku, Sendai 980-8575, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tohoku University Graduate School of Medicine
Division name Department of Dermatology
Zip code
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)

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

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

Other
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/ctr_e/ctr_view.cgi?recptno=R000012386

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.