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

Study Overview
=================
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.

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

Conditions
-----------------
Melasma

Intervention / Treatment
-----------------
* Device: Q switched Nd YAG laser
* Device: Fractional CO2 laser


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>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<br>* Laser device emitting Q switched Nd YAG aiming for skin toning<br>Device: Fractional CO2 laser<br>* Laser device emitting fractionated ablative laser aiming for skin resurfacing<br>|
| No Intervention: Follow -up period<br>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 |