UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003617 |
|---|---|
| Receipt number | R000004385 |
| Scientific Title | A study of safety and efficacy of R410 for acne vulgaris. |
| Date of disclosure of the study information | 2010/05/17 |
| Last modified on | 2010/10/20 13:44:23 |
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Basic information
Public title
A study of safety and efficacy of R410 for acne vulgaris.
Acronym
A study of safety and efficacy of R410 for acne vulgaris.
Scientific Title
A study of safety and efficacy of R410 for acne vulgaris.
Scientific Title:Acronym
A study of safety and efficacy of R410 for acne vulgaris.
Region
| Japan |
Condition
Condition
acne vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the safety and efficacy of the two preparations with a different pH of R410 for acne vulgaris.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent reduction of the total acne lesion counts
Key secondary outcomes
-Percent reduction of the non-inflammatory lesion counts
-Decrease percentage of the inflammatory lesion counts
-Improvement level in the lesion counts
-Safety: Adverse event
-Assessment by subject
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A preparation of R410 will be applied to the specified one-side face, in the morning and night after washing for 12 weeks.
Interventions/Control_2
Another preparation with a different pH of R410 will be applied to the other specified one-side face, in the morning and night after washing for 12 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
| 12 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Subjects with total acne (non-inflammatory and inflammatory) lesion more than 30 counts on the face (forehead, cheek, and jaw).
- 10 to 40 inflammatory lesions
- 20 non-inflammatory lesions or more
- 2 nodules/cysts or less
2)Subjects with acne lesions on both sides of face which are almost the same severity.
3)Subjects who understood the requirements of the study and signed the informed consent forms.
Key exclusion criteria
1.Subjects with clinically-significant disorder that might influence the outcome of this study.
2.Acne conglobata, acne fulminans, or secondary acne (e.g. chloracne, drug-induced acne).
3.Subjects for whom the systemic treatment of acne vulgaris is necessary.
4.Underlying diseases or skin symptoms (e.g. atopic dermatitis, perioral dermatitis, rosacea), with topical or systemic treatment which could interfere with the study assesment.
5.History of hypersensitivity to any components of the study preparations.
6.Change in the use of facial cleanser or skin care products for acne within the past 1 month.
7.Use of the following items within the specified washout period or during the study.
7.1 Topical preparations and therapy applied to the sites to be studied
1)Topical preparations
i)Use of the following preparations within the past 4 weeks.
-Retinoids
ii)Use of the following preparations within the past 2 weeks.
-Benzoyl Peroxide
-Corticosteroids
-Exfoliating products including hydroxy acids, except facial cleanser
2)Therapy etc.
i)Chemical peels, laser treatment, photo therapy, esthetic treatment, surgery of face.
7.2 Systemic drugs
1)Use of the following preparations within the past 12 weeks.
-Retinoids
2)Use of the following preparations within the past 4 weeks.
-Other acne treatments including antimicrobials etc. (except vitamin and cystein preparations)
-Corticosteroids
-Hormone preparations
-Kampo preparations likely to be effective for acne
8.Subjects who are improper to entry this study, with some complications, e.g. severe heart disease, renal disorder, hepatic disorder, respiratory disease, cardiovascular disease, immune disorder.
9.Female who is pregnant, trying to become pregnant (self- declared), during this study period, or breast feeding.
10.Participation in another clinical study within the past 3 months.
11.Subjects who are improper as the participant in the study in judgement of the principal or the other investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Kawashima/Nobukazu Hayashi |
Organization
Tokyo Woman's Medical University
Division name
Dermatology
Zip code
Address
8-1 Kawada-cho Shinjuku-ku, Tokyo 162-8666, Japan
TEL
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 Shiomome Bldg., 1-2-20, Kaigan, Minato-ku, Tokyo 105-0222, 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
| 2010 | Year | 05 | Month | 17 | 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 | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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 | 05 | Month | 14 | Day |
Last modified on
| 2010 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004385
