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Completed

NCT Number: NCT03848013

Treatment 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.

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Kasr Al Ainy Hospital Dermatology department

Cairo, El Manial, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Q switched Nd YAG laser

Device

Laser device emitting Q switched Nd YAG aiming for skin toning

Fractional CO2 Laser

Device

Laser device emitting fractionated ablative laser aiming for skin resurfacing

Primary outcomes

  1. Modified Melasma Area and Severity index change.

    Time frame: 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.

  2. Melanin index change.

    Time frame: 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.

  3. percentage of clinical improvement

    Time frame: 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.

  4. patient satisfaction rate

    Time frame: 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.

Secondary outcomes

  1. Modified Melasma Area and Severity Index change.

    Time frame: 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.

  2. Melanin index change.

    Time frame: 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.

  3. percentage of clinical improvement

    Time frame: 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.

  4. patient satisfaction rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2019
Registry last updated
Jan 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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