1064-nm Q-switched Nd:YAG Laser and Intradermal Tranexamic Acid for Melasma
Primary Purpose
Melasma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intradermal tranexamic acid
Nd-YAG
Sponsored by
About this trial
This is an interventional treatment trial for Melasma
Eligibility Criteria
Inclusion Criteria:
- patients > 20 years old with refractory melasma to topical treatment
Exclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Nd-YAG
Nd-YAG and intradermal tranexamic acid
Arm Description
ND-YAG only
Nd-YAG combine with intradermal tranexamic acid
Outcomes
Primary Outcome Measures
Melasma area severity index (MASI)
Secondary Outcome Measures
Quality of life by MELASQOL scale
Improvement by patient's global assessment (PGA),
Patient's satisfaction (VAS)
Improvement by physician's global assessment (PhGA)
Full Information
NCT ID
NCT03008655
First Posted
December 22, 2016
Last Updated
December 29, 2016
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03008655
Brief Title
1064-nm Q-switched Nd:YAG Laser and Intradermal Tranexamic Acid for Melasma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
METHODS: Twenty patients with melasma were included in a randomized controlled observer-blinded study with split-face design. Each side of the face was randomly allocated to either 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) or low influence 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection.Complication Improvement of melasma was assessed by Melasma area severity index (MASI),physician's global assessment (PhGA), MELASQOL scale, patient's global assessment (PGA), and patient's satisfaction at baseline,6th week,10th week after first treatment and 3 months, and 6 months after last treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nd-YAG
Arm Type
Active Comparator
Arm Description
ND-YAG only
Arm Title
Nd-YAG and intradermal tranexamic acid
Arm Type
Experimental
Arm Description
Nd-YAG combine with intradermal tranexamic acid
Intervention Type
Procedure
Intervention Name(s)
intradermal tranexamic acid
Intervention Description
intradermal tranexamic acid injection
Intervention Type
Device
Intervention Name(s)
Nd-YAG
Intervention Description
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)
Primary Outcome Measure Information:
Title
Melasma area severity index (MASI)
Time Frame
6 months after last treatment
Secondary Outcome Measure Information:
Title
Quality of life by MELASQOL scale
Time Frame
6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Title
Improvement by patient's global assessment (PGA),
Time Frame
6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Title
Patient's satisfaction (VAS)
Time Frame
6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Title
Improvement by physician's global assessment (PhGA)
Time Frame
6th week,10th week after first treatment and 3 months, and 6 months after last treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients > 20 years old with refractory melasma to topical treatment
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Chen Huang, MD
Phone
886970746772
Email
dhist2002@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Chen Huang, MD
Organizational Affiliation
Taipei Medical University WanFang Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
1064-nm Q-switched Nd:YAG Laser and Intradermal Tranexamic Acid for Melasma
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