UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of glycolic acid for the treatment of the pigmented lesion; Prospective, randomized, and split-face comparative study
Title of the study (Brief title)	Effectiveness of glycolic acid for the treatment study
Region	Japan

Condition
Condition	pigmented lesion
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effectiveness of glycolic acid for the pigmented lesion
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical study
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	The essectiveness of the Glycolic acid lotion
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	The pigmented lesion on the face
Key exclusion criteria	The patients have the severe disease
Target sample size	30

Research contact person
Name of lead principal investigator	Chikako Kaminaka
Organization	wakayama Medical University
Division name	Department of Dermatology
Address	811-1KimiideraWakayama
TEL	073-441-0661
Email	kamikami@wakayama-med.ac.jp

Public contact
Name of contact person	Chikako Kaminaka
Organization	Wakayama Medical University
Division name	Department of Dermatology
Address	811-1KimiideraWakayama
TEL	073-441-0661
Homepage URL
Email	kamikami@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	JMEC, Co., Ltd.
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 01 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 17 Day
Last modified on	2018 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023377