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

Not Applicable

• Conditions: Melasma
• Interventions: Procedure: intradermal tranexamic acid; Device: Nd-YAG

• Registration Number: NCT03008655
• Lead Sponsor: Taipei Medical University WanFang Hospital

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.

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2016-12-29
• Last Update Submitted: 2016-12-29
• Study Start: 2017-01
• Study First Posted: 2017-01-02
• Last Update Posted: 2017-01-02
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nd-YAG and intradermal tranexamic acid	intradermal tranexamic acid	Nd-YAG combine with intradermal tranexamic acid
Nd-YAG and intradermal tranexamic acid	Nd-YAG	Nd-YAG combine with intradermal tranexamic acid
Nd-YAG	Nd-YAG	ND-YAG only

Primary Outcome Measures

Name	Time	Method
Melasma area severity index (MASI)	6 months after last treatment

Secondary Outcome Measures

Name	Time	Method
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