UMIN-CTR Clinical Trial

Public title

An analysis of the factors involved in acne vulgaris

Acronym

An analysis of the factors involved in acne vulgaris

Scientific Title

An analysis of the factors involved in acne vulgaris

Scientific Title:Acronym

An analysis of the factors involved in acne vulgaris

Region

North America

Condition

Acne vulgaris

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yoshito Takahashi

Organization

Kao Corporation

Division name

R&D -Core Technology- Biological Science Research

Zip code

Address

5-3-28, Kotobuki-tyou, Odawara-shi, Kanagawa, 250-0002, JAPAN

TEL

0465-34-6116

Email

takahashi.yoshito@kao.co.jp

Name of contact person

1st name
Middle name
Last name	Takayoshi Inoue

Organization

Kao Corporation

Division name

R&D -Core Technology- Biological Science Research

Zip code

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

0285-68-7498

Homepage URL

Email

inoue.takayoshi@kao.co.jp

Institute

Kao Corporation

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

RCTS, Inc.(Texas, USA)

Date of disclosure of the study information

2015

Year

10

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

08

Month

26

Day

Date of IRB

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

Other related information

An exploration of the genes involved in acne vulgaris

Registered date

2015

Year

10

Month

21

Day

Last modified on

2017

Year

10

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022493