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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003415
Receipt No. R000004137
Scientific Title Verification of the effectiveness of the combination therapy with an oral antibiotics and Adapalene for the treatment of acne vulgaris.
Date of disclosure of the study information 2010/03/31
Last modified on 2011/04/21

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Basic information
Public title Verification of the effectiveness of the combination therapy with an oral antibiotics and Adapalene for the treatment of acne vulgaris.
Acronym Verification of the effectiveness of the combination therapy with an oral antibiotics and Adapalene for the treatment of acne vulgaris.
Scientific Title Verification of the effectiveness of the combination therapy with an oral antibiotics and Adapalene for the treatment of acne vulgaris.
Scientific Title:Acronym Verification of the effectiveness of the combination therapy with an oral antibiotics and Adapalene for the treatment of 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 effectiveness and the best treatment period of combination therapy with an oral antibiotics and Adapalene for the treatment of acne vulgaris in Japanese patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Decrease percentage of the number of inflammatory lesion.
Key secondary outcomes -Change of the number of inflammatory lesion and comedone
-Safety
-Change in patient QOL(Skindex-16)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Adapalene gel will be applied to the surface of the face overall once daily after washing the face before retiring in the evening for 4 weeks. In the first 2 weeks, Faropenem Sodium Hydrate will be also administered three times daily.
Interventions/Control_2 Adapalene gel will be applied to the surface of the face overall once daily after washing the face before retiring in the evening for 4 weeks. In parallel with this treatment, Faropenem Sodium Hydrate will be also administered three times daily for 4 weeks.
Interventions/Control_3 Adapalene gel will be applied to the surface of the face overall once daily after washing the face before retiring in the evening for 4 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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with acne vulgaris expressing from moderate to severe symptoms in guideline
2) Patients who gave their written informed consent
Key exclusion criteria 1) Patients taking some drugs(oral,topical or injective agents)expected to be indicated for the treatment of acne within 4 weeks
2) Patients with hypersensitivity to any of the study drugs
3) Patients continuously receiving non-steroidal anti-inflammatory drugs
4) Women who are pregnant,might be pregnant or lactating
5) Patients who are considered unsuitable for this study by the investigator
Target sample size 150

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization EBMs Co.,Ltd
Division name Clinical Business Division
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Tokyo Woman's Medical University
Institute
Department

Funding Source
Organization Non-Profit Organization Health Institute Research of Skin
Organization
Division
Category of Funding Organization Other
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 03 Month 31 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 02 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 31 Day
Last modified on
2011 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004137

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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