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

NCT ID: NCT03008655

Last Updated: 2017-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nd-YAG

ND-YAG only

Group Type ACTIVE_COMPARATOR

Nd-YAG

Intervention Type DEVICE

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)

Nd-YAG and intradermal tranexamic acid

Nd-YAG combine with intradermal tranexamic acid

Group Type EXPERIMENTAL

intradermal tranexamic acid

Intervention Type PROCEDURE

intradermal tranexamic acid injection

Nd-YAG

Intervention Type DEVICE

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)

Interventions

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intradermal tranexamic acid

intradermal tranexamic acid injection

Intervention Type PROCEDURE

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)

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huang Yu Chen

Attending physician of Dermatology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu Chen Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University WanFang Hospital

Central Contacts

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Yu Chen Huang, MD

Role: CONTACT

886970746772

Other Identifiers

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N201610008

Identifier Type: -

Identifier Source: org_study_id

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