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

October 21, 2020 updated by: Woraphong Manuskiatti, M.D., Mahidol University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Department of Dermatology, Siriraj Hospital, Mahidol University
        • Contact:
        • Sub-Investigator:
          • Chadakan Yan, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: split face - left side
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
ACTIVE_COMPARATOR: split face - right side
Drug: topical 2% hydroquinone
treatment one side of the face with topical 2% hydroquinone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of using combination of 755-nm picosecond alexandrite laser
Time Frame: 6 months
Monitor side effect from picesecond alexandrite laser
6 months
Safety of using 2% hydroquinone
Time Frame: 6 months
side effect of topical 2%Hydroquinone use
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

February 1, 2021

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (ACTUAL)

October 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • si 082/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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