Unique ID issued by UMIN | UMIN000011524 |
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Receipt number | 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 17:54:16 |
Clinical efficacy of hydroquinone in glaucoma patients with prostaglandin-induced eyelid pigmentation
Clinical efficacy of hydroquinone in prostaglandin-induced eyelid pigmentation
Clinical efficacy of hydroquinone in glaucoma patients with prostaglandin-induced eyelid pigmentation
Clinical efficacy of hydroquinone in prostaglandin-induced eyelid pigmentation
Japan |
Prostaglandin-induced eyelid pigmentation
Ophthalmology | Dermatology |
Others
NO
To investigate efficacy and safety of hydroquinone in glaucoma patients with prostaglandin-induced eyelid pigmentation
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Skin color change of eyelid
Patient self-assessment of change in eyelid color
Frequency and severity of adverse effects
Interventional
Single arm
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
1
Treatment
Medicine |
Hydroquinone (RXDH) is applied to either eyelid twice daily for 3 months
20 | years-old | <= |
Not applicable |
Male and Female
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
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
30
1st name | |
Middle name | |
Last name | Koichi ONO |
Juntendo Tokyo-Koto Geriatric Medical Center, Juntendo University School of Medicine
Ophthalmology
3-3-20 Shinsuna, Koto-ku, Tokyo, JAPAN 136-0075
03-5632-3111
kono@juntendo.ac.jp
1st name | |
Middle name | |
Last name | Koichi ONO |
Juntendo Tokyo-Koto Geriatric Medical Center, Juntendo University School of Medicine
Ophthalmology
3-3-20 Shinsuna, Koto-ku, Tokyo, JAPAN 136-0075
03-5632-3111
kono@juntendo.ac.jp
Juntendo Tokyo-Koto Geriatric Medical Center, Juntendo University School of Medicine
Non-Profit Organization Health Institute Research of Skin
Non profit foundation
Japan
Juntendo Tokyo-Koto Geriatric Medical Center, Dermatology
Ueno Eye Clinic
Skin Care Ueno Clinic
Non-Profit Organization Health Institute Research of Skin
NO
2013 | Year | 08 | Month | 26 | Day |
Unpublished
Completed
2013 | Year | 07 | Month | 23 | Day |
2013 | Year | 09 | Month | 01 | Day |
2015 | Year | 01 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 05 | Month | 15 | Day |
2015 | Year | 12 | Month | 31 | Day |
2013 | Year | 08 | Month | 20 | Day |
2015 | Year | 08 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013475
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