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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20161010004 |
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Date of registration:
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10/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Prospective Randomized Controlled Study of Oral Tranexamic Acid for Prevention of Postinflammatory Hyperpigmentation after Q-Switched Nd-YAG (532 nm) Laser
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Scientific title:
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A Prospective Randomized Controlled Study of Oral Tranexamic Acid for Prevention of Postinflammatory Hyperpigmentation after Q-Switched Nd-YAG (532 nm) Laser |
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Date of first enrolment:
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23/08/2016 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20161010004 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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N/A
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Duangrat
Pruettivorawongse |
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Address:
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270 Rama VI Rd, Thung Phaya Thai, Ratchathewi, Bangkok 10400
10400
bangkok
Thailand |
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Telephone:
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080-627-2724 |
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Email:
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bepruet@gmail.com |
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Affiliation:
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Division of Dermatology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital |
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Name:
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Duangrat
Pruettivorawongse |
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Address:
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270 Rama VI Rd, Thung Phaya Thai, Ratchathewi, Bangkok 10400
10400
bangkok
Thailand |
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Telephone:
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080-627-2724 |
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Email:
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bepruet@gmail.com |
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Affiliation:
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Division of Dermatology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: Solar lentigine size > 5 mm
Age between 18 to 60 years old
Exclusion criteria: 1.patients treated solar lentigine with
-topical medication within 7 days
-dermabrasion within 2 weeks
-chemical peels within 2 weeks
-cryotherapy within 2 weeks
-laser therapy within 4 weeks
2.allergy to transamine
3.on oral contraceptive pills, antiplatelet or anticoagulant drug
4.contraindication to tranexamic acid includings cardiovascular diseease, cerebrovascular disease, abnormal coagulation, pregnancy, lactation, acquired color blindness
5.history of keloid
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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solar lentigines
post inflammatory hyperpigmentation
solar lentigines
post inflammatory hyperpigmentation
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solar lentigines
post inflammatory hyperpigmentation
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Intervention(s)
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Experimental Drug,Placebo Comparator Other
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Transamine,placebo
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oral transamine 1500 mg,oral placebo
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Primary Outcome(s)
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efficacy of transamine in prophylaxis of post inflammatory hyperpigmentation 0,2,4,6,12 week colorimeter, VISIA, digital photographs, dermoscope
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Secondary Outcome(s)
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safety of transamine 2,4,6,12 week questionnaire and physical examination ,risk of post inflammatory hyperpigmentation 0,4,6,12 week dermoscope
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Source(s) of Monetary Support
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Division of Dermatology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
Committee on Human Rights Related to research Invoiving Human Subjects
662-201-1000 Ext.
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Results
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Results available:
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Date Posted:
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Date Completed:
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24/04/2017 |
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URL:
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