UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An analysis of the factors involved in acne vulgaris
Title of the study (Brief title)	An analysis of the factors involved in acne vulgaris
Region	North America

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

Objectives
Narrative objectives1	An exploration of the genes involved in acne vulgaris
Basic objectives2	Others
Basic objectives -Others	An exploration of the genes involved in acne vulgaris
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Collection of skin samples with or without acne vulgaris. Evaluation of the content of sebum secretion and collection of sebum and skin flora.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	punch biopsy on acne and non-acne regions
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	18 years-old <=
Age-upper limit	45 years-old >=
Gender	Male
Key inclusion criteria	1_Males between the ages of 18 and 45. 2_Subjects with acne, papule and/or pustule, on face, shoulder, chest and back, or healthy persons. 3_Who agrees about a blood test of HIV and hepatitis B and C. 4_Who agrees about the punch biopsy on acne and non-acne regions 5_Who is willing to accept blood drawn, measurement of sebum secretion and collection of the sebum and skin flora. 6_Who agrees not to wash the face on the days of clinical study. 7_Who agrees not to eat anything after 22 o'clock of the day immediately before his biopsy 8_Who is fluent in English and can read, understand and sign an IRB approved Informed Consent form. 9_Who is available for all study visits.
Key exclusion criteria	1_Individuals who contract diabetes, HIV/AIDS or autoimmune disorders, and hepatitis B or C. 2_Individuals with cuts, lacerations, abrasions, or bruises on the biopsy sites 3_Individuals with tattoos on the biopsy sites. 4_Individuals who participated in other clinical study within 28days. 5_Individuals with allergies (self-reported) to wound dressings and adhesives, latex allergy or allergies towards the local anesthetic. 6_Individuals with any relevant past or present medical history which may affect the study results or may lead to increased risk to the subject in the judgment of the Sub-Investigator. 7_Individuals who use prescription medication or OTC topical medication at the biopsy site(s). 8_Individuals with needle phobia. 9_Individuals with self-reported problems in wound healing and/or disposition to develop extensive scars (keloids, hypertrophic wounds). 10_Individuals who are not prepared to give written informed consent 11_Individuals receiving medical treatment that, in the opinion of the Sub-Investigator, may interfere with this study. 12_Individuals taking medications, that in the opinion of the Sub-Investigator could interfere with this study.
Target sample size	10

Research contact person
Name of lead principal investigator	Yoshito Takahashi
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	5-3-28, Kotobuki-tyou, Odawara-shi, Kanagawa, 250-0002, JAPAN
TEL	0465-34-6116
Email	takahashi.yoshito@kao.co.jp

Public contact
Name of contact person	Takayoshi Inoue
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7498
Homepage URL
Email	inoue.takayoshi@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	RCTS, Inc.(Texas, USA)

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 26 Day
Anticipated trial start date	2015 Year 08 Month 26 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	An exploration of the genes involved in acne vulgaris

Management information
Registered date	2015 Year 10 Month 21 Day
Last modified on	2017 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022493