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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022092
Receipt No. R000025449
Scientific Title Evaluation of subjects with dry skin and desquamation with repeated use of clear facial lotion and milky facial lotion for 8 weeks
Date of disclosure of the study information 2016/04/27
Last modified on 2016/07/28

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Basic information
Public title Evaluation of subjects with dry skin and desquamation 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 desquamation
Scientific Title Evaluation of subjects with dry skin and desquamation 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 desquamation
Region
Japan

Condition
Condition Atopic dermatitis
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Safety and efficacy evaluation of the dry skin and desquamation 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

Assessment
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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Repeated use of clear facial lotion P and milky facial lotion P for 8 weeks
Interventions/Control_2 Repeated use of clear facial lotion Q and milky facial lotion Q 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

Eligibility
Age-lower limit
25 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria ・Japanese females aged from 25 to less than 50 years old at the time informed consent was provided
・Subjects with very mild or mild dry skin and desquamation, 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 atopic dermatitis, sebum deficiency, or xeroderma on the face
・Subjects with mild or greater redness/erythema on the face
・Subjects using a topical steroid or a tacrolimus ointment on the face
・Subjects using a medical-use topical moisturizer on the face
・Subjects receiving systemic administration of steroids or immunosuppressive agents
・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

Research contact person
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

Public contact
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

Sponsor
Institute DRC Co., Ltd.
Institute
Department

Funding Source
Organization Maruho Co., Ltd.
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
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 DRC株式会社評価センター(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 27 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
2016 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 27 Day
Last modified on
2016 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025449

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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