Clinical trial NCT03008655: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Melasma
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Melasma area severity index (MASI)
timeFrame: 6 months after last treatment
Secondary outcomes:
measure: Quality of life by MELASQOL scale
timeFrame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
measure: Improvement by patient's global assessment (PGA),
timeFrame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
measure: Patient's satisfaction (VAS)
timeFrame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
measure: Improvement by physician's global assessment (PhGA)
timeFrame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Yu Chen Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: