Treatment of Melasma Using Q-switched Nd: YAG Laser and Fractional CO2 Laser Separately and in Combination

Reatment of Melasma Using Q-switched Nd: YAG Laser and Fractional CO2 Laser Separately and in Combination

• 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.

Study Overview

• Status: Completed
• Conditions: Melasma
• Intervention / Treatment: Device: Q switched Nd YAG laser; Device: Fractional CO2 laser

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Manial
    • Cairo, El Manial, Egypt
      • Cairo University Kasr Al Ainy Hospital Dermatology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• melasma patients above 18 years

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment; Treatment of cases of melasma using Q switched Nd YAG laser and Fractional CO2 laser separately and in combination	Device: Q switched Nd YAG laser; Laser device emitting Q switched Nd YAG aiming for skin toning; Device: Fractional CO2 laser; Laser device emitting fractionated ablative laser aiming for skin resurfacing
No Intervention: Follow -up period; follow up of the treated cases for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Melasma Area and Severity Index change.	Evaluate the role of additional fractional co2 laser to the previously Q switched Nd: YAG treated melasma patients by measuring changes in modified MASI score before treatment and after treatment and follow-p period.	6 months to 1 year
Melanin index change.	Evaluate the role of additional fractional co2 laser to the previously Q switched Nd: YAG treated melasma patients 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 role of additional fractional co2 laser to the previously Q switched Nd: YAG treated melasma patients 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 role of additional fractional co2 laser to the previously Q switched Nd: YAG treated melasma patients by comparing patient satisfaction before treatment and after treatment and follow-p period.	6 months to 1 year

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis
• Other Study ID Numbers: CairoU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No