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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005305
Receipt No. R000006301
Scientific Title A placebo-controlled study of R410 in subjects with acne vulgaris.
Date of disclosure of the study information 2011/03/27
Last modified on 2012/04/19

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Basic information
Public title A placebo-controlled study of R410 in subjects with acne vulgaris.
Acronym A placebo-controlled study of R410 in subjects with acne vulgaris.
Scientific Title A placebo-controlled study of R410 in subjects with acne vulgaris.
Scientific Title:Acronym A placebo-controlled study of R410 in subjects with acne vulgaris.
Region
Japan

Condition
Condition acne vulgaris
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of R410 compared with placebo in subjects of 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

Additionally, the following items are also evaluated in subjects with post-inflammatory pigmentation induced by acne vulgaris.
-visual evaluation of post-inflammatory pigmentation
-Improvement level in the post-inflammatory pigmentation

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
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 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 A preparation of placebo 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 on the face.
2.Acne conglobata, acne fulminans, or secondary acne.
3.Underlying diseases or skin symptoms, with topical or systemic treatment which could interfere with the study assesment.
4.History of hypersensitivity to any components of the study preparations.
5.Change in the use of facial cleanser or skin care products for acne within the past 1 month.
6.Subjects who administering or receiving therapy of the following items within the specified washout period or during the study.
6.1 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 (inclued adapalene, Vitamin A) containing products
ii)Use of the following preparations within the past 2 weeks.
-Benzoyl Peroxide
-Corticosteroids
-Exfoliating products
2)Receiving the following therapies within the past 4 weeks.
i)Surgery of face, chemical peels, laser treatment, photo therapy, esthetic treatment.
6.2 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 (excepting topical dose such as nosal drop or eye drop)
-Hormone preparations
-Kampo preparations likely to be effective for acne
7.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.
8.Female who is pregnant, trying to become pregnant (self- declared), during this study period, or breast feeding.
9.Participation in another clinical study within the past 3 months.
10.Subjects who are improper as the participant in the study in judgement of the principal or the other investigators.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Kawashima
Organization Tokyo Woman's Medical University
Division name Dermatology
Zip code
Address 8-1 Kawada-cho Shinjuku-ku, Tokyo 162-8666, 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
Zip code
Address 1-2-20, Kaigan, Minato-ku, Tokyo 105-0222, 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 03 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
2011 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
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 03 Month 24 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=R000006301

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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