NCT04597203

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

September 8, 2020

Last Update Submit

October 21, 2020

Conditions

Melasma

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Safety of using combination of 755-nm picosecond alexandrite laser

    6 months

  • Safety of using 2% hydroquinone

    6 months

Study Arms (2)

split face - left side

EXPERIMENTAL
Device: 755-nm picosecond alexandrite laser with topical 2% hydroquinone

split face - right side

ACTIVE COMPARATOR
Drug: topical 2% hydroquinone

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

split face - left side
topical 2% hydroquinoneDRUG

treatment one side of the face with topical 2% hydroquinone

split face - right side

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female age 18-60 years
  • Melasma on both cheeks - epidermal or mixed type
  • Fitzpatrick Skin type III-V

You may not qualify if:

  • History of retinoid or other keratolytic drugs used within 6 months before enrolled
  • History of keloid
  • photosensitivity
  • Immunocompromised host

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36345697DERIVED

MeSH Terms

Conditions

Melanosis

Interventions

hydroquinone

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

woraphong Manuskiatti, M.D.

CONTACT

02-419-1000doctorlaser@gmail.com

Chadakan Yan, M.D.

CONTACT

66882334090chadakanyan4090@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2020

First Posted

October 22, 2020

Study Start

October 1, 2020

Primary Completion

January 1, 2021

Study Completion

February 1, 2021

Last Updated

October 23, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)