NCT03848013

Brief Summary

  • All participants will be divided into 2 groups : Group A \& Group B.
  • Group A will be subjected to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser to one side of the face \& fractional co2 laser to the other side of the face with one month interval between sessions.
  • Group B will be subjected also to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser to one side of the face \& an additional fractional co2 laser to the other side of the face using the above mentioned parameters with one month interval between sessions.
  • Response to treatment will be assessed using the Melanin Index (MI) score, Melasma Area and Severity Index (MASI) score, spectrophotometer ( Derma catch, colorix, Neuchatel, Switzerland ) and a subjective self-assessment method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

December 12, 2018

Last Update Submit

January 8, 2020

Conditions

Melasma

Outcome Measures

Primary Outcomes (4)

  • Modified Melasma Area and Severity index change.

    Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing the results through measuring modified MASI score before treatment and after treatment and follow-p period.

    6 months to 1 year

  • Melanin index change.

    Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing the results by taking spectrophotometer readings (melanin index) before treatment and after treatment and follow-p period.

    6 months to 1 year

  • percentage of clinical improvement

    Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing the results of masked dermatologists' observation of clinical photographs before treatment and after treatment and follow-p period.

    6 months to 1 year

  • patient satisfaction rate

    Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing patient satisfaction before treatment and after treatment and follow-p period.

    6 months to 1 year

Secondary Outcomes (4)

  • Modified Melasma Area and Severity Index change.

    6 months to 1 year

  • Melanin index change.

    6 months to 1 year

  • percentage of clinical improvement

    6 months to 1 year

  • patient satisfaction rate

    6 months to 1 year

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Treatment of cases of melasma using Q switched Nd YAG laser and Fractional CO2 laser separately and in combination

Device: Q switched Nd YAG laserDevice: Fractional CO2 laser

Follow -up period

NO INTERVENTION

follow up of the treated cases for 2 months

Interventions

Q switched Nd YAG laserDEVICE

Laser device emitting Q switched Nd YAG aiming for skin toning

Treatment
Fractional CO2 laserDEVICE

Laser device emitting fractionated ablative laser aiming for skin resurfacing

Treatment

Eligibility Criteria

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

You may qualify if:

  • melasma patients above 18 years

You may not qualify if:

  • Pregnancy.
  • Usage of chemical peeling 1 month prior to the study.
  • Isotretinoin intake 6 months prior to the study.
  • Any laser procedure related to melasma lesions 1 month prior to the study.
  • Active herpetic lesions.
  • Any concurrent active skin disease within the treated area.
  • Photosensitive skin conditions such as systemic lupus erythematous.
  • History of delayed wound healing.
  • Keloid formation.
  • Bleeding diathesis.
  • Medical conditions such as diabetes mellitus \& autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Kasr Al Ainy Hospital Dermatology department

Cairo, El Manial, Egypt

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Design

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

Study Record Dates

First Submitted

December 12, 2018

First Posted

February 20, 2019

Study Start

January 1, 2017

Primary Completion

April 1, 2019

Study Completion

June 1, 2019

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations

EG(1)