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

Not Applicable

• Conditions: Melasma
• Interventions: Drug: topical 2% hydroquinone; Device: 755-nm picosecond alexandrite laser with topical 2% hydroquinone

• Registration Number: NCT04597203
• Lead Sponsor: Mahidol University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-08
• Status Verified: 2020-10
• Study Start: 2020-10
• Study First Submitted QC: 2020-10-15
• Last Update Submitted: 2020-10-21
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-23
• Primary Completion: 2021-01
• Study Completion: 2021-02

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
split face - right side	topical 2% hydroquinone	-
split face - left side	755-nm picosecond alexandrite laser with topical 2% hydroquinone	-

Primary Outcome Measures

Name	Time	Method
Melanin index measured by Mexameter® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma	6 months	measuring in au
Average melanin measured by Antera3D® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma	6 months	measuring in au
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	6 months	score range 0-24
Patient satisfaction quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma	6 months	score 0 -100%
Physician evaluation quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma	6 months	score 0 -100%

Secondary Outcome Measures

Name	Time	Method
Safety of using combination of 755-nm picosecond alexandrite laser	6 months	Monitor side effect from picesecond alexandrite laser
Safety of using 2% hydroquinone	6 months	side effect of topical 2%Hydroquinone use

Trial Locations

Locations (1)

Department of Dermatology, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand