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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004442
Receipt No. R000005317
Scientific Title Examination of combination and maintenance therapy with Adapalene Gel 0.1% for acne vulgaris
Date of disclosure of the study information 2010/10/26
Last modified on 2012/06/21

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Basic information
Public title Examination of combination and maintenance therapy with Adapalene Gel 0.1% for acne vulgaris
Acronym Examination of combination and maintenance therapy with Adapalene Gel 0.1% for acne vulgaris
Scientific Title Examination of combination and maintenance therapy with Adapalene Gel 0.1% for acne vulgaris
Scientific Title:Acronym Examination of combination and maintenance therapy with Adapalene Gel 0.1% for 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 of combination and maintenance therapy with Adapalene Gel 0.1% and topical antibiotics or oral antibiotics for the treatment of acne vulgaris in Japan patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes (Study-1)Percent reduction in total lesion (inflammatory lesion + comedone) counts of acne vulgaris on the face(inflammatory lesion + comedone)
(Study-2)Period until increasing of inflammatory lesion
Key secondary outcomes *Change in QOL
*Overall clinical evaluation(after study1)
*Safety

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 considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 (Study-1)Group A:Nadifloxacin will be applied for 12 weeks.
Interventions/Control_2 (Study-1)Group B:Adapalene gel 0.1% and Nadifloxacin will be applied for 12 weeks.
Interventions/Control_3 (Study-1)Group C:Adapalene gel 0.1% and Roxithromycin or Nadifloxacin will be applied for totally 12 weeks.
Interventions/Control_4 (Study-2)Grop D:After study-1,Adapalene gel 0.1% will be applied for 12 weeks.
Interventions/Control_5 (Study-2)Group E:After study-1,non-treatment for 12weeks.
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 who has inflammatory lesion
2)Patients who agreeded with their written informed consent
Key exclusion criteria 1) Patients taking some medications (orally,topically, or injective agents, or chemical treatments) expected to be effective to acne vulgaris within one month before the registration of this research.
2) Patients with hypersensitivity to any of the study drugs
3) Patients continuously receiving non-steroidal anti-inflammatory drugs(ibuprofen,etc)
4) Women who are pregnant,might be pregnant or lactating or planning a pregnancy
5) Patients who are considered to be unsuitable for this study by the investigator
Target sample size 350

Research contact person
Last 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,Shinjyuku-ku,Tokyo 162-8666,Japan
TEL
Email

Public contact
1st 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 10 Month 26 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 08 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2012 Year 04 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 10 Month 26 Day
Last modified on
2012 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005317

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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