UMIN-CTR Clinical Trial

Public title

Evaluation of the dry skin and mild acne vulgaris subjects with repeated use of clear facial lotion and milky facial lotion for 8 weeks

Acronym

Safety and efficacy evaluation of repeated use of clear facial lotion and milky facial lotion for dry skin and mild acne vulgaris

Scientific Title

Evaluation of the dry skin and mild acne vulgaris subjects with repeated use of clear facial lotion and milky facial lotion for 8 weeks

Scientific Title:Acronym

Safety and efficacy evaluation of repeated use of clear facial lotion and milky facial lotion for dry skin and mild acne vulgaris

Region

Japan

Condition

Acne vulgaris

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Safety and efficacy evaluation of the dry skin and mild acne vulgaris subjects with repeated use of clear facial lotion and milky facial lotion for 8 weeks

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Evaluation of dermatological assessment and questionnaire before and after the repeated use of clear facial lotion and milky facial lotion for 1, 4, 6, and 8 weeks

Key secondary outcomes

Measurement of transepidermal water loss (TEWL) and skin moisture

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Repeated use of clear facial lotion R and milky facial lotion R for 8 weeks

Interventions/Control_2

Repeated use of clear facial lotion S and milky facial lotion S for 8 weeks

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

20

years-old

<=

Age-upper limit

45

years-old

>

Gender

Female

Key inclusion criteria

･Japanese females aged from 20 to less than 45 years old at the time informed consent was provided
･Subjects with mild acne vulgaris of the same degree on both the left and right of the face, and with low skin moisture as measured by a screening test
･Voluntary study participants who provided written informed consent

Key exclusion criteria

･Subjects with moderate or greater acne vulgaris
･Subjects using oral contraceptives or oral anti-androgen drugs that affects their acne vulgaris
･Subjects receiving systemic administration of a steroid or immunosuppressive agent
･Subjects using a medical-use topical moisturizer on the face
･Subjects with allergies to cosmetics or foods
･Pregnant women, those who may be pregnant, lactating women, or women who hope to become pregnant during the study period
･Subjects who has participated in other human studies within the past four weeks, or subjects who plan to participate in other human studies during the planned period of the study
･Subjects who were considered inappropriate for the study by an investigator

Target sample size

24

Name of lead principal investigator

1st name
Middle name
Last name	Sumio Kondo

Organization

Medecal Corporation Kensho-kai, Fukushima Healthcare Center

Division name

Department of Internal Medicine, Neurosurgery

Zip code

Address

2-12-16, Tamagawa, Fukushima-ku, Osaka

TEL

06-6441-6848

Email

ko293434@ares.eonet.ne.jp

Name of contact person

1st name
Middle name
Last name	Masafumi Takano

Organization

DRC Co., Ltd.

Division name

Product Testing Department

Zip code

Address

Tabuchi Bldg. No.9 5F, 2-10-31, Higashi-Temma, Kita-ku, Osaka

TEL

06-6882-1130

Homepage URL

Email

m.takano@drc-web.co.jp

Institute

DRC Co., Ltd.

Institute

Department

Personal name

Organization

Maruho 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

DRC株式会社評価センター（大阪府）

Date of disclosure of the study information

2016

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

2016

Year

04

Month

08

Day

Date of IRB

Anticipated trial start date

2016

Year

05

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

04

Month

27

Day

Last modified on

2016

Year

07

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025452