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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

Primary Purpose

Melasma

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
755-nm picosecond alexandrite laser with topical 2% hydroquinone
topical 2% hydroquinone
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Dermatology, Siriraj Hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

split face - left side

split face - right side

Arm Description

Outcomes

Primary Outcome Measures

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
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
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
Patient satisfaction quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
score 0 -100%
Physician evaluation quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
score 0 -100%

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2020
Last Updated
October 21, 2020
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04597203
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
split face - left side
Arm Type
Experimental
Arm Title
split face - right side
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
755-nm picosecond alexandrite laser with topical 2% hydroquinone
Intervention Description
treatment one side of the face with 755-nm picosecond alexandrite laser with topical 2% hydroquinone
Intervention Type
Drug
Intervention Name(s)
topical 2% hydroquinone
Intervention Description
treatment one side of the face with topical 2% hydroquinone
Primary Outcome Measure Information:
Title
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
Description
score range 0-24
Time Frame
6 months
Title
Melanin index measured by Mexameter® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
Description
measuring in au
Time Frame
6 months
Title
Average melanin measured by Antera3D® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
Description
measuring in au
Time Frame
6 months
Title
Patient satisfaction quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
Description
score 0 -100%
Time Frame
6 months
Title
Physician evaluation quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
Description
score 0 -100%
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety of using combination of 755-nm picosecond alexandrite laser
Description
Monitor side effect from picesecond alexandrite laser
Time Frame
6 months
Title
Safety of using 2% hydroquinone
Description
side effect of topical 2%Hydroquinone use
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
woraphong Manuskiatti, M.D.
Phone
02-419-1000
Email
doctorlaser@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chadakan Yan, M.D.
Phone
66882334090
Email
chadakanyan4090@gmail.com
Facility Information:
Facility Name
Department of Dermatology, Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woraphong Manuskiatti, M.D.
Phone
02-419-1000
Email
doctolaser@gmail.com
First Name & Middle Initial & Last Name & Degree
Woraphong Manuskiatti, M.D.
First Name & Middle Initial & Last Name & Degree
Rungsima Wanitphakdeedacha, M.D.
First Name & Middle Initial & Last Name & Degree
Chadakan Yan, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36345697
Citation
Manuskiatti W, Yan C, Gulfan MCB, Techapichetvanich T, Wanitphakdeedecha R. Combination of a 755-nm picosecond laser and hydroquinone 2% cream versus hydroquinone 2% cream alone for the treatment of melasma: A randomized, split-face, and controlled trial. Lasers Surg Med. 2022 Dec;54(10):1245-1250. doi: 10.1002/lsm.23615. Epub 2022 Nov 8.
Results Reference
derived

Learn more about this trial

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

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