1064-nm Q-switched Nd:YAG Laser and Intradermal Tranexamic Acid for Melasma

December 29, 2016 updated by: Huang Yu Chen, Taipei Medical University WanFang Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nd-YAG
ND-YAG only
Device: Nd-YAG
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)
Experimental: Nd-YAG and intradermal tranexamic acid
Nd-YAG combine with intradermal tranexamic acid
Device: Nd-YAG
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)
Procedure: intradermal tranexamic acid
intradermal tranexamic acid injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Melasma area severity index (MASI)
Time Frame: 6 months after last treatment
6 months after last treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life by MELASQOL scale
Time Frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
6th week,10th week after first treatment and 3 months, and 6 months after last treatment
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
6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Patient's satisfaction (VAS)
Time Frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
6th week,10th week after first treatment and 3 months, and 6 months after last treatment
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
6th week,10th week after first treatment and 3 months, and 6 months after last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Investigators

  • Principal Investigator: Yu Chen Huang, MD, Taipei Medical University WanFang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Estimate)

January 2, 2017

Last Update Submitted That Met QC Criteria

December 29, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201610008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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