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

Not Applicable

Completed

• Conditions: Melasma
• Interventions: Device: Q switched Nd YAG laser; Device: Fractional CO2 laser

• Registration Number: NCT03848013
• Lead Sponsor: Kasr El Aini Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Primary Completion: 2019-04
• Study Completion: 2019-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
percentage of clinical improvement	6 months to 1 year	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.
patient satisfaction rate	6 months to 1 year	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.
Melanin index change.	6 months to 1 year	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.
Modified Melasma Area and Severity index change.	6 months to 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Melanin index change.	6 months to 1 year	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.
patient satisfaction rate	6 months to 1 year	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.
Modified Melasma Area and Severity Index change.	6 months to 1 year	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.
percentage of clinical improvement	6 months to 1 year	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.

Trial Locations

Locations (1)

Cairo University Kasr Al Ainy Hospital Dermatology department; 🇪🇬 Cairo, El Manial, Egypt