1064-nm Q-switched Nd:YAG Laser and Intradermal Tranexamic Acid for Melasma
A Split-face Comparison of Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Vitamin C vs Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Intradermal Tranexamic Acid Injection for Melasma:a Single Blinded, Randomised Study
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
BACKGROUND: Melasma is a chronic, often relapsing skin disorder, with poor long-term results from all current therapies.Q switched 1064nm Nd:YAG laser and intradermal tranexamic acid both showed efficacy on the treatment of melasma. However, no combination therapy of both be reported. OBJECTIVES: To compare the efficacy of low influence Q switched 1064nm Nd:YAG laser and low influence Q switched 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection for melasma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedFirst Posted
Study publicly available on registry
January 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 2, 2017
December 1, 2016
11 months
December 22, 2016
December 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Melasma area severity index (MASI)
6 months after last treatment
Secondary Outcomes (4)
Quality of life by MELASQOL scale
6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Improvement by patient's global assessment (PGA),
6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Patient's satisfaction (VAS)
6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Improvement by physician's global assessment (PhGA)
6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Study Arms (2)
Nd-YAG
ACTIVE COMPARATORND-YAG only
Nd-YAG and intradermal tranexamic acid
EXPERIMENTALNd-YAG combine with intradermal tranexamic acid
Interventions
intradermal tranexamic acid injection
six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz)
Eligibility Criteria
You may qualify if:
- patients \> 20 years old with refractory melasma to topical treatment
You may not qualify if:
- History of keloid, active eczema, active acne in the face, history of facial eczema, photosensitivity, use of isotretinoin in the past 6 months, pregnancy, and high exposure to sunlight or UV light (UVA or UVB)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu Chen Huang, MD
Taipei Medical University WanFang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician of Dermatology Department
Study Record Dates
First Submitted
December 22, 2016
First Posted
January 2, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
January 2, 2017
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share