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Recruitment status Completed
Unique ID issued by UMIN UMIN000011524
Receipt No. R000013475
Scientific Title Clinical efficacy of hydroquinone in glaucoma patients with prostaglandin-induced eyelid pigmentation
Date of disclosure of the study information 2013/08/26
Last modified on 2015/08/11

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Basic information
Public title Clinical efficacy of hydroquinone in glaucoma patients with prostaglandin-induced eyelid pigmentation
Acronym Clinical efficacy of hydroquinone in prostaglandin-induced eyelid pigmentation
Scientific Title Clinical efficacy of hydroquinone in glaucoma patients with prostaglandin-induced eyelid pigmentation
Scientific Title:Acronym Clinical efficacy of hydroquinone in prostaglandin-induced eyelid pigmentation
Region
Japan

Condition
Condition Prostaglandin-induced eyelid pigmentation
Classification by specialty
Ophthalmology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy and safety of hydroquinone in glaucoma patients with prostaglandin-induced eyelid pigmentation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Skin color change of eyelid
Key secondary outcomes Patient self-assessment of change in eyelid color
Frequency and severity of adverse effects

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 Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Hydroquinone (RXDH) is applied to either eyelid twice daily for 3 months
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)20 years or older when the informed consent was taken
2)Glaucoma was diagnosed in both eyes
3)Subjects treated for 3 months with prostaglandin analogues
4)Symmetry in the skin color of eyelid between right and left eyes
5)Patients who agreed and signed to the participation in this study
6)Patients who can observed the schedule written in trial implementation protocol
Key exclusion criteria 1)Severe glaucoma(a Humphery field analyzer: MD <-18dB)
2)Subjects who do not continue taking prostaglandin analogues
3)Subjects who took the internal medicine containing tranexamic acid, L- cysteine or vitamin C in the past 2 months
4)Subjects who used the quasi drugs or the cosmetic products for whitening in the past 3 months
5)Subjects who underwent the plastic treatment (e.g. LASER, Photo facial, and chemical peeling) in the past 2 months
6)Subjects who are exposed to the severe ultraviolet rays
7)Subjects with severe systematic diseases(e.g. hepatic disease)
8)Females who are pregnant or breast feeding, and females of childbearing potential during trial periods
9)Subjects who were enrolled in other clinical trials in the past 1 month
10)Subjects who are considered ineligible by the principal or other investigators
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi ONO
Organization Juntendo Tokyo-Koto Geriatric Medical Center, Juntendo University School of Medicine
Division name Ophthalmology
Zip code
Address 3-3-20 Shinsuna, Koto-ku, Tokyo, JAPAN 136-0075
TEL 03-5632-3111
Email kono@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi ONO
Organization Juntendo Tokyo-Koto Geriatric Medical Center, Juntendo University School of Medicine
Division name Ophthalmology
Zip code
Address 3-3-20 Shinsuna, Koto-ku, Tokyo, JAPAN 136-0075
TEL 03-5632-3111
Homepage URL
Email kono@juntendo.ac.jp

Sponsor
Institute Juntendo Tokyo-Koto Geriatric Medical Center, Juntendo University School of Medicine
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 Non-Profit Organization Health Institute Research of Skin
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Juntendo Tokyo-Koto Geriatric Medical Center, Dermatology

Ueno Eye Clinic
Skin Care Ueno Clinic
Name of secondary funder(s) Non-Profit Organization Health Institute Research of Skin

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 08 Month 26 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
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
2013 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 01 Day
Last follow-up date
2015 Year 01 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 05 Month 15 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 20 Day
Last modified on
2015 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013475


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