UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation of cleansing foam or facial sunscreen for acne vulgaris patients
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Takashi Koikeda
Organization	Shiba Palace Clinic
Division name	Shiba Palace Clinic
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	Miwa Kaneko
Organization	SOUKEN Co.,Ltd
Division name	Clinical trial division
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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