UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020936
Receipt No. R000024152
Scientific Title Safety evaluation of cleansing foam or facial sunscreen for acne vulgaris patients
Date of disclosure of the study information 2016/02/08
Last modified on 2016/04/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Safety evaluation of cleansing foam or facial sunscreen for acne vulgaris patients
Acronym Safety evaluation of cleansing foam or facial sunscreen for acne vulgaris
Scientific Title Safety evaluation of cleansing foam or facial sunscreen for acne vulgaris patients
Scientific Title:Acronym Safety evaluation of cleansing foam or facial sunscreen for acne vulgaris
Region
Japan

Condition
Condition Acne vulgaris
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Safety evaluation of the skin with repeated use of cleansing foam or facial sunscreen for acne vulgaris
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of dermatological assessment and questionnaire before and after the repeated use of cleansing foam or facial sunscreen for 1 and 4 weeks
Key secondary outcomes Blood test, measurement of transepidermal water loss (TEWL) and skin moisture

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Repeated use of a single-agent of cleansing foam or facial sunscreen for 4 weeks
Interventions/Control_2
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
50 years-old >=
Gender Female
Key inclusion criteria 1)Japanese females aged from 20 to 50 years old at the time informed consent was provided
2)Count of 1-20 acne lesions (pimples) on the right or left half of the face
3)Patients who provided written informed consent to change from their everyday use of cleanser or facial sunscreen to the test agent during the study period
Key exclusion criteria ・Patients with severe or greater acne vulgaris
・Patients receiving systemic administration of a drug for a purpose other than acne vulgaris therapy
・Patients receiving a topically administered drug on the face for a purpose other than acne vulgaris therapy
・Pregnant women, those who may be pregnant, lactating women, or women who hope to become pregnant during the study period
・Patients for whom the test agent is contraindicated
・Patients who were considered inappropriate for the study by an investigator
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Shiba Palace Clinic
Zip code
Address Daiwa A Hamamatsucho 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL 03-5408-1599
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Miwa Kaneko
Organization SOUKEN Co.,Ltd
Division name Clinical trial division
Zip code
Address Daiwa A Hamamatsucho 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL 03-5408-1555
Homepage URL
Email m_kaneko@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

Funding Source
Organization Maruho 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 芝パレスクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 02 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
2015 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 11 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
2016 Year 02 Month 08 Day
Last modified on
2016 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=R000024152

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.