UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020494
Receipt number R000023639
Scientific Title Clinical trial on the usefulness and the safety of imidazole antifungal topical agent; ketoconazole cream for acne vulgaris
Date of disclosure of the study information 2016/03/01
Last modified on 2020/03/18 14:16:28

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Basic information

Public title

Clinical trial on the usefulness and the safety of imidazole antifungal topical agent; ketoconazole cream for acne vulgaris

Acronym

Clinical trial on the usefulness and the safety of imidazole antifungal topical agent; ketoconazole cream for acne vulgaris

Scientific Title

Clinical trial on the usefulness and the safety of imidazole antifungal topical agent; ketoconazole cream for acne vulgaris

Scientific Title:Acronym

Clinical trial on the usefulness and the safety of imidazole antifungal topical agent; ketoconazole cream for acne vulgaris

Region

Japan


Condition

Condition

acne vulgaris

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the effectiveness of ketoconazol cream for acne vulgaris

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

inflammatory acne and comedo)by ketoconazole cream and nadifloxacin cream

Key secondary outcomes

Change of visual analogue scale score by the subjects three months after the start of this study


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

apply to half side of the face
-A group
R;ketoconazole cream, L;nadifloxacin cream
0.5g twice a day, topical, administration period: 12weeks

Interventions/Control_2

apply to half side of the face
-B group
L;ketoconazole cream, R;nadifloxacin cream
0.5g twice a day, topical, administration period: 12weeks

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

bisymmetrically acne vulgaris on face

Key exclusion criteria

-Patient who takes steroid or antifungus.
-Patient who has history of contact dermatitis due to external medicine which contains antifungus or antibiotic.
-If the attending physician has determined ineligible as a subject of this study.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akiko Yagami

Organization

Fujita Health University

Division name

Department of dermatology

Zip code


Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref. 470-1192

TEL

0562-93-9256

Email

ayagami@fujita-hu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akiko Yagami

Organization

Fujita Health University

Division name

Department of dermatology

Zip code


Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref. 470-1192

TEL

0562-93-9256

Homepage URL


Email

ayagami@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

NONE

Organization

Division

Category of Funding Organization

Self funding

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

2016 Year 03 Month 01 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

2015 Year 09 Month 04 Day

Date of IRB

2016 Year 01 Month 14 Day

Anticipated trial start date

2016 Year 03 Month 01 Day

Last follow-up date

2019 Year 12 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

2016 Year 01 Month 08 Day

Last modified on

2020 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023639


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name