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

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03848013
• Other study ID #: CairoU
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 2019

Study information

• Verified date: January 2020
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Device:
• Q switched Nd YAG laser
Laser device emitting Q switched Nd YAG aiming for skin toning
• Fractional CO2 laser
Laser device emitting fractionated ablative laser aiming for skin resurfacing

Locations

Country	Name	City	State
Egypt	Cairo University Kasr Al Ainy Hospital Dermatology department	Cairo	El Manial

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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