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

Primary Purpose

Melasma

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Q switched Nd YAG laser
Fractional CO2 laser
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo University Kasr Al Ainy Hospital Dermatology department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment

Follow -up period

Arm Description

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

follow up of the treated cases for 2 months

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
December 12, 2018
Last Updated
January 8, 2020
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03848013
Brief Title
Treatment of Melasma Using Q-switched Nd: YAG Laser and Fractional CO2 Laser Separately and in Combination
Official Title
Reatment of Melasma Using Q-switched Nd: YAG Laser and Fractional CO2 Laser Separately and in Combination
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Treatment of cases of melasma using Q switched Nd YAG laser and Fractional CO2 laser separately and in combination
Arm Title
Follow -up period
Arm Type
No Intervention
Arm Description
follow up of the treated cases for 2 months
Intervention Type
Device
Intervention Name(s)
Q switched Nd YAG laser
Intervention Description
Laser device emitting Q switched Nd YAG aiming for skin toning
Intervention Type
Device
Intervention Name(s)
Fractional CO2 laser
Intervention Description
Laser device emitting fractionated ablative laser aiming for skin resurfacing
Primary Outcome Measure Information:
Title
Modified Melasma Area and Severity index change.
Description
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.
Time Frame
6 months to 1 year
Title
Melanin index change.
Description
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.
Time Frame
6 months to 1 year
Title
percentage of clinical improvement
Description
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.
Time Frame
6 months to 1 year
Title
patient satisfaction rate
Description
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.
Time Frame
6 months to 1 year
Secondary Outcome Measure Information:
Title
Modified Melasma Area and Severity Index change.
Description
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.
Time Frame
6 months to 1 year
Title
Melanin index change.
Description
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.
Time Frame
6 months to 1 year
Title
percentage of clinical improvement
Description
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.
Time Frame
6 months to 1 year
Title
patient satisfaction rate
Description
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.
Time Frame
6 months to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Cairo University Kasr Al Ainy Hospital Dermatology department
City
Cairo
State/Province
El Manial
Country
Egypt

12. IPD Sharing Statement

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

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