UMIN-CTR Clinical Trial

Basic information
Public title	Skin pigmentation in acne vulgaris patients A study on usefulness of vitamin C gel
Acronym	A study on usefulness of vitamin C gel
Scientific Title	Skin pigmentation in acne vulgaris patients A study on usefulness of vitamin C gel
Scientific Title:Acronym	A study on usefulness of vitamin C gel
Region	Japan

Condition
Condition	Acne valgaris patients
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of the usefulness of vitamin C gels in skin pigmentation of acne vulgaris
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of post-inflammatory pigmentation(PIH):4 weeks after treatment starts, 8weeks, 12 weeks evaluation of improvement by 'investigator's global improvement rating' in each observation period
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	Treatment
Type of intervention	Other
Interventions/Control_1	After washing the test product twice a day, in the morning and before bedtime, apply the appropriate amount to the affected area (pigmentation site) every day for 12 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	16 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with pigmentation symptoms of acne vulgaris
Key exclusion criteria	1)Patients with experience of skin symptoms such as contact dermatitis by the components and similar components of this research. 2)A patient with an inappropriate rash or other lesion in the affected area. 3)Patients with unstable symptoms of disease and complications that cause pigmentation. 4)Patients undergoing treatment for pigmentation or patients who have not been over one year since the end of treatment. 5)Pregnant, possibely pregnant, hope to be pregnant, or breastfeeding woman.
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Kurokawa Middle name Last name Ichiro
Organization	Meiwa Hospital, Medical Corporation
Division name	Department of Dermatology
Zip code	6638186
Address	4-31 Naruo-machi, Nishinomiya-shi, Hyogo
TEL	0789-47-1767
Email	kurokawa.i@meiwa-hospital.com

Public contact
1st name of contact person	1st name Ogaki Middle name Last name Yoshitaka
Organization	EBC&M LLC.
Division name	Business Promotion Department
Zip code	1050011
Address	TOWER FRONT KAMIYACHO 5F,1-3-8,Higashiazabu,Minato-ku Tokyo 106-0044 Japan
TEL	03-6435-3833
Homepage URL
Email	yoshitaka_ogaki@ebc-m.com

Sponsor
Institute	Meiwa Hospital, Medical Corporation
Institute
Department

Funding Source
Organization	Meiwa Hospital, Medical Corporation
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	Japan Conference of Clinical Reserarch IRB
Address	2-27-1, MinamiIkebukuro, Toshima-ku,Tokyo
Tel	03-6868-7022
Email	nakagawa-kengo@cts-smo.com

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	2018 Year 06 Month 10 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	35
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	2017 Year 11 Month 07 Day
Date of IRB	2018 Year 03 Month 22 Day
Anticipated trial start date	2018 Year 03 Month 26 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry	2019 Year 02 Month 10 Day
Date trial data considered complete	2019 Year 03 Month 10 Day
Date analysis concluded	2019 Year 03 Month 15 Day

Other
Other related information

Management information
Registered date	2018 Year 06 Month 08 Day
Last modified on	2019 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036598