UMIN-CTR Clinical Trial

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

Peoples who has wrinkles in an eye area
or pigmentation.

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Organization

TOKIWA pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

04

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

04

Month

26

Day

Last modified on

2016

Year

10

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012386