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

Melasma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03008655
• Other study ID #: N201610008
• Status: Not yet recruiting
• Phase: N/A
• First received: December 22, 2016
• Last updated: December 29, 2016
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Taipei Medical University WanFang Hospital
• Contact: Yu Chen Huang, MD
• Phone: 886970746772
• Email: dhist2002[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Procedure:
• intradermal tranexamic acid
intradermal tranexamic acid injection

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Melasma area severity index (MASI)		6 months after last treatment	No
Secondary	Quality of life by MELASQOL scale		6th week,10th week after first treatment and 3 months, and 6 months after last treatment	No
Secondary	Improvement by patient's global assessment (PGA),		6th week,10th week after first treatment and 3 months, and 6 months after last treatment	No
Secondary	Patient's satisfaction (VAS)		6th week,10th week after first treatment and 3 months, and 6 months after last treatment	No
Secondary	Improvement by physician's global assessment (PhGA)		6th week,10th week after first treatment and 3 months, and 6 months after last treatment	No