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

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04597203
• Other study ID #: si 082/2019
• Status: Recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: February 2021

Study information

• Verified date: October 2020
• Source: Mahidol University
• Contact: woraphong Manuskiatti, M.D.
• Phone: 02-419-1000
• Email: doctorlaser[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

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

Drug:
• topical 2% hydroquinone
treatment one side of the face with topical 2% hydroquinone

Locations

Country	Name	City	State
Thailand	Department of Dermatology, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	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	6 months
Primary	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	6 months
Primary	Patient satisfaction quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma	score 0 -100%	6 months
Primary	Physician evaluation quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma	score 0 -100%	6 months
Secondary	Safety of using combination of 755-nm picosecond alexandrite laser	Monitor side effect from picesecond alexandrite laser	6 months
Secondary	Safety of using 2% hydroquinone	side effect of topical 2%Hydroquinone use	6 months