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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003875
Receipt No. R000004665
Scientific Title Clinical effect of R610 for retinoic acid induced dermatitis.
Date of disclosure of the study information 2010/07/08
Last modified on 2010/10/20

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Basic information
Public title Clinical effect of R610 for retinoic acid induced dermatitis.
Acronym Clinical effect of R610 for retinoic acid induced dermatitis.
Scientific Title Clinical effect of R610 for retinoic acid induced dermatitis.
Scientific Title:Acronym Clinical effect of R610 for retinoic acid induced dermatitis.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate of R610 anti-inflammatory effect on retinoic acid induced dermatitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Degrees of dermatitis (erythema, edema, crust, drying, desquamation, feeling of stimulation, burning sensation, itching, irritation)
Key secondary outcomes Efficacy
-Skin symptom score
-Hemoglobin index
-Subject impression
Other
-Melanin index
-Degree of skin tone color scale

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Twice a day (morning and evening).
After face washing, apply the DRxHQ Brightning to the whole face, apply the retinoic acid preparation to pigmented area, and, apply the R610 to the same pigmented area.
Treatment period;
Retinoic acid preparation for 4 weeks, DRxHQ Brightning and R610 for 8 weeks.
Interventions/Control_2 Twice a day (morning and evening).
After face washing, apply the DRxHQ Brightning to the whole face, apply the retinoic acid preparation to pigmented area, and, apply the vehicle only to the same pigmented area.
Treatment period;
Retinoic acid preparation for 4 weeks, DRxHQ Brightning and vehicle 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Subjects who have more than 2 counts of solar lentigo (each is over 5 mm in diameter) on the face, which are separated more than 1 cm from each other.
2. Subjects who understood the requirements of the study and signed the informed consent forms.
Key exclusion criteria 1. Subjects with rash, contact dermatitis, skin inflammation e.g. sunburn, and other skin abnormality.
2. Subjects with the following treatment history at baseline.
2.1 Treatment region
1)Topical preparations
i)Within the past 12 weeks
-Retinoic acid, adapalene
ii)Within the past 2 weeks
-Anti-inflammatory drugs (corticosteroid, nonsteroidal anti-inflammatory drug)
2)Other therapy
i)Within the past 4 weeks
-Chemical peelings, laser treatment, photo-therapy, plastic surgery treatment.
2.2 Systemic drugs, supplements
i)Within the past 12 weeks
-Retinoic acid
ii)Within the past 4 weeks
-Corticosteroid
3. Subjects with skin viral infection e.g. flat wart, herpes simplex.
4. Subjects who changed face cleanser or skin care products for the test regions within the past 2 weeks.
5. Subjects who exposed to the ultraviolet rays of the sun.
6. Subjects with systemic diseases, e.g. severe heart disease, renal disease, hepatic disease, respiratory disease, cardiovascular disease, and immune disease.
7. Subjects with atopic dermatitis or have a history of atopic dermatitis.
8. Subjects who had experience the contact dermatitis caused by the use of hydroquinone.
9. Females who are pregnant, trying to become pregnant (self-declared), during this study period, or breast feeding.
10. Participants of another clinical study within 4 months of study initiation.
11. Subjects who are improper as a participant in this study in judgement by the principal or other investigators.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kotaro Yoshimura
Organization University of Tokyo, School of Medicine
Division name Plastic Surgery
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
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

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
2010 Year 07 Month 08 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
2010 Year 06 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 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
2010 Year 07 Month 06 Day
Last modified on
2010 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004665

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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