Efficacy and Safety of Using Combination of 755-nm Picosecond Alexandrite Laser and 2% Hydroquinone Compared With 2% Hydroquinone Alone for the Treatment of Melasma: a Randomized Split-face Controlled Trial

Mahidol University20 enrolled

Overview

This study aims to assess the efficacy and safety of using combination of 755-nm picosecond alexandrite laser and 2% hydroquinone compared with 2% hydroquinone alone for the treatment of melasma: A randomized split-face controlled trial

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Melasma

Interventions

755-nm picosecond alexandrite laser with topical 2% hydroquinoneDEVICE

treatment one side of the face with 755-nm picosecond alexandrite laser with topical 2% hydroquinone

topical 2% hydroquinoneDRUG

treatment one side of the face with topical 2% hydroquinone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Both male and female age 18-60 years * Melasma on both cheeks - epidermal or mixed type * Fitzpatrick Skin type III-V Exclusion Criteria: * History of retinoid or other keratolytic drugs used within 6 months before enrolled * History of keloid * photosensitivity * Immunocompromised host

Locations (1)

Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, Thailand

RECRUITING

Outcomes

Primary Outcomes

Modified melasma area and severity index score(mMASI) - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma of using combination of 755-nm picosecond alexandrite laser and 2% hydroquinone

score range 0-24

Time frame: 6 months

Melanin index measured by Mexameter® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma

measuring in au

Time frame: 6 months

Average melanin measured by Antera3D® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma

measuring in au

Time frame: 6 months

Patient satisfaction quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma

score 0 -100%

Time frame: 6 months

Physician evaluation quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma

score 0 -100%

Time frame: 6 months

Secondary Outcomes

Safety of using combination of 755-nm picosecond alexandrite laser

Monitor side effect from picesecond alexandrite laser

Time frame: 6 months

Safety of using 2% hydroquinone

side effect of topical 2%Hydroquinone use

Time frame: 6 months

Central Contacts

woraphong Manuskiatti, M.D.

CONTACT

02-419-1000 doctorlaser@gmail.com

Chadakan Yan, M.D.

CONTACT

66882334090 chadakanyan4090@gmail.com

Data from ClinicalTrials.gov

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