UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031488
Receipt number R000035944
Scientific Title The evaluation of skin care agents in Japanese patients with acne vulgaris
Date of disclosure of the study information 2018/02/26
Last modified on 2020/05/26 15:55:50

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Basic information

Public title

The evaluation of skin care agents in Japanese patients with acne vulgaris

Acronym

The evaluation of skin care agents in Japanese patients with acne vulgaris

Scientific Title

The evaluation of skin care agents in Japanese patients with acne vulgaris

Scientific Title:Acronym

The evaluation of skin care agents in Japanese patients with acne vulgaris

Region

Japan


Condition

Condition

acne vulgaris

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

we evaluated the safety and efficacy of skin care agents for acne vulgaris patients with conventional treatment

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

clinical findings
grade of severity

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

interval: 4-8 weeks
after washing face

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

10 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

the patients with acne vulgaris

Key exclusion criteria

the patients with other skin diseases

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Yamamoto
Middle name
Last name Yuki

Organization

Wakayama Medical University

Division name

Dermatology

Zip code

6410021

Address

811-1 Kimiidera, Wakayama, Japan

TEL

073-441-0661

Email

yukiy@wakayama-med.ac.jp


Public contact

Name of contact person

1st name Kaminaka
Middle name
Last name Chikako

Organization

Wakayama Medical University

Division name

Dermatology

Zip code

6410021

Address

811-1 Kimiidera, Wakayama, Japan

TEL

073-441-0661

Homepage URL


Email

kamikami@wakayama-med.acj.jp


Sponsor or person

Institute

Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Wakayama Medical University

Address

811-1 Kimiidera, Wakayama, Japan

Tel

073-441-0661

Email

yukiy@wakayama-med.ac.jp


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

和歌山県立医科大学付属病院


Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 26 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

2018 Year 03 Month 01 Day

Date of IRB

2018 Year 03 Month 02 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 26 Day

Last modified on

2020 Year 05 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035944


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name