UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005379 |
|---|---|
| Receipt number | 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 10:37:02 |
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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
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
Sponsor or person
Institute
Rohto Pharmaceutical Co., LTD
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006317
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| Registered date | File name |
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