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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005379
Receipt No. R000006317
Scientific Title Evaluation of efficacy on pigmentation by R1110 using In vivo confocal laser microscopy.
Date of disclosure of the study information 2011/04/13
Last modified on 2012/04/19

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Basic information
Public title Evaluation of efficacy on pigmentation by R1110 using In vivo confocal laser microscopy.
Acronym Evaluation of efficacy on pigmentation by R1110.
Scientific Title Evaluation of efficacy on pigmentation by R1110 using In vivo confocal laser microscopy.
Scientific Title:Acronym Evaluation of efficacy on pigmentation by R1110.
Region
Japan

Condition
Condition solar lentigo or melasma
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of R1110 for pigmentation disorders.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -Melanin index
-Degree of skin tone color scale
-Observation of internal skin by in vivo confocal laser microscopy
-Skin symptom score (safety)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Melasma:After face washing, apply the cosmetics to the whole face by usual methods, and apply the test product to the study area (1), twice a day (morning and evening).Then, if necessary, other beauty essence or cream products are applied to the whole face without the study area.In the morning, the subjects must use the designated sunscreen products.Treatment period; 12 weeks.
Interventions/Control_2 Melasma:After face washing, apply the cosmetics to the whole face by usual methods, and apply the test product to the study area (2), twice a day (morning and evening).Then, if necessary, other beauty essence or cream products are applied to the whole face without the study area.In the morning, the subjects must use the designated sunscreen products.Treatment period; 12 weeks.
Interventions/Control_3 Solar lentigo:After face washing, apply the cosmetics to the whole face by usual methods, and apply the test product to the study area, twice a day (morning and evening).Then, if necessary, other beauty essence or cream products are applied to the whole face without the study area.In the morning, the subjects must use the designated sunscreen products.Treatment period; 12 weeks.
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 1) 20 years old or more than it at the date the informed consent was taken on.
2) Subjects with solar lentigo or melasma.
3) Subjects who have the compliance for study protocol.
4) Subjects who signed the informed consent forms approved by the ethical board of the study institution.
Key exclusion criteria 1) Subjects who used hydroquinone products or retinoic acid products (concentration: more than 0.1%) within the past 3 months.
2) Subjects who used the internal medicine containing tranexamic acid or L- cysteine or vitamin C or E within the past 3 months.
3) Subjects who underwent the plastic treatment or the beauty salon treatment within the past 2 months.
4) Subjects who used the quasi drugs or the cosmetic products (e.g. the products containing vitamin C or arbutin, etc. Except for hydroquinone) for whitening within the past 1 month from informed consent.
5) Subjects who underwent the hormone complement treatment within the past 1 month.
6) Subjects who are exposed to the severe ultraviolet rays of the sun.
7) Subjects with severe diseases, e.g. hepatic disease and renal disease.
8) Subjects with allergy or atopic dermatitis, and a history of contact dermatitis.
9) Females who are pregnant or breast feeding, and females of childbearing potential.
10) Subjects who are considered ineligible by the principal or other investigators.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kayoko Matsunaga
Organization Fujita Health University, School of Medicine
Division name Department of Dermatology
Zip code
Address 1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.470-1192.Japan
TEL 0562-93-9256
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Rohto Pharmaceutical Co., LTD
Division name Clinical Development Division, R&D
Zip code
Address 20F Shiodome Bldg., 1-2-20, Kaigan, Minato-ku, Tokyo, Japan
TEL
Homepage URL
Email

Sponsor
Institute Rohto Pharmaceutical Co., LTD
Institute
Department

Funding Source
Organization Rohto Pharmaceutical Co., LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2011 Year 04 Month 13 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
2011 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2011 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 05 Day
Last modified on
2012 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006317

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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