UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058202
Receipt number R000066540
Scientific Title Clinical trial to evaluate the effect of a new skincare formulation (FQWO71W1) on rough skin recovery
Date of disclosure of the study information 2025/06/20
Last modified on 2025/06/17 12:03:34

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Basic information

Public title

Clinical trial to evaluate the effect of a new skincare formulation (FQWO71W1) on rough skin recovery

Acronym

Clinical trial to evaluate the effect of a new skincare formulation (FQWO71W1) on rough skin recovery

Scientific Title

Clinical trial to evaluate the effect of a new skincare formulation (FQWO71W1) on rough skin recovery

Scientific Title:Acronym

Clinical trial to evaluate the effect of a new skincare formulation (FQWO71W1) on rough skin recovery

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Confirmation of the effect of a new skincare formulation (FQWO71W1) on rough skin recovery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Observation of skin condition after repeated use of a new skincare formulation (FQWO71W1)

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

The new skincare formulation (FQWO71W1) and placebo will be applied repeatedly to areas of rough skin

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

20 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Men and women aged 20 to 60 years at the time of informed consent.
2)Able to visit the testing site and undergo the required examinations on the designated dates.
3)Deemed eligible for participation in this study by the principal investigator.

Key exclusion criteria

1)Individuals with severe atopic dermatitis.
2)Individuals receiving hormone replacement therapy.
3)Individuals with a history of allergy to cosmetics or drugs, or those with sensitive skin.
4)Individuals who are pregnant, possibly pregnant, or breastfeeding.
5)Individuals with or suspected of having severe cardiac, renal, or hepatic impairment, or circulatory diseases.
6)Individuals who are currently undergoing or have undergone within the past 3 months treatments that may affect skin function, such as chemical peels, laser treatments, or the use of physician-prescribed medications including hydroquinone, high-concentration vitamin C, and retinoic acid on the forearm.
7)Individuals currently participating in other clinical trials.
8)Individuals with large scars, warts, or rashes on the medial aspect of the forearm.
9)Individuals deemed ineligible by the study investigator.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Riichi
Middle name
Last name Takahashi

Organization

FANCL Corporation

Division name

Research Institute

Zip code

2440806

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa

TEL

045-820-3612

Email

takahashi_riichi@fancl.co.jp


Public contact

Name of contact person

1st name Yoko
Middle name
Last name Imai

Organization

FANCL Corporation

Division name

Research Institute

Zip code

244-0806

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa

TEL

045-820-3539

Homepage URL


Email

yoko1607@fancl.co.jp


Sponsor or person

Institute

FANCL Corporation

Institute

Department

Personal name



Funding Source

Organization

FANCL Corporation

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

FANCL Corporation Ethics Committee

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa

Tel

045-820-3565

Email

hisaitou@fancl.co.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



Other administrative information

Date of disclosure of the study information

2025 Year 06 Month 20 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

Preinitiation

Date of protocol fixation

2025 Year 05 Month 23 Day

Date of IRB


Anticipated trial start date

2025 Year 06 Month 23 Day

Last follow-up date

2025 Year 07 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 06 Month 17 Day

Last modified on

2025 Year 06 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066540