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Fractional co2 Laser Followed by Either Vitamin c or Tranexamic Acid in Treatment of Melasma.

Primary Purpose

Melasma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fractional co2 laser
Sponsored by
Khadija Qenawi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All types of melasma (epidermal, dermal, and mixed) will be included . Patients older than 19 years of age. Exclusion Criteria: Pregnancy, breastfeeding. Patients taking drugs that induce facial pigmentation e.g, oral contraceptive pills, or hormonal replacement therapy at the time of the study or during the past 12 months. Patients using of any topical bleaching within 1 month before recruitment. Employment of chemical peels or laser therapy during the past 6 months. Concomitant use of anticoagulants, bleeding disorders.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Patients with all types of melasma

    Arm Description

    Fractional ablative CO2 laser : For each patient, Right side of the face : Fractional ablative CO2 laser will be followed by immediate topical application of vitamin c 3% . Left side of the face: Fractional ablative CO2 laser will be followed by immediate topical application of tranexamic acid. Fractional ablative CO2 laser sessions will be performed using the following parameters: power 8-10 W(according to the skin type), spacing 1000 μm (5.3% density), dwell time 400 μs, and stack . During the session, protective goggles will be used both by the patient and by the physician.

    Outcomes

    Primary Outcome Measures

    Efficacy and safety of fractional CO2 laser in treatment of melasma.
    1.: For each patient, Right side of the face : Fractional ablative CO2 laser will be followed by immediate topical application of vitamin c 3% . Left side of the face: Fractional ablative CO2 laser will be followed by immediate topical application of tranexamic acid. Fractional ablative CO2 laser sessions will be performed using the following parameters: power 8-10 W (according to the skin type), spacing 1000 μm (5.3% density), dwell time 400 μs, and stack . During the session, protective goggles will be used both by the patient and by the physician. acid in the treatment of melasma. 2 .To assess the value of dermoscope in measuring of the response to treatment in melasma patients compared to clinical scoring.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 28, 2023
    Last Updated
    August 14, 2023
    Sponsor
    Khadija Qenawi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05911698
    Brief Title
    Fractional co2 Laser Followed by Either Vitamin c or Tranexamic Acid in Treatment of Melasma.
    Official Title
    Fractional co2 Laser Followed by Either Vitamin c or Tranexamic Acid in Treatment of Melasma. Asplit Face Dermoscopic and Clinical Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 28, 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Khadija Qenawi

    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
    The aim of the study: 1.To compare the efficacy and safety of fractional CO2 laser in combination with vitamin c and tranexamic acid in the treatment of melasma. 2 .To assess the value of dermoscope in measuring of the response to treatment in melasma patients compared to clinical scoring.
    Detailed Description
    Melasma is a chronic dermatologic condition defined by hyperpigmented macules and patches that appear in areas of sun exposure . Traditionally, the mainstays of treatment for melasma have been topical bleaching agents and strict photoprotection. Additional adjuvant treatment modalities include chemical peels, dermabrasion, and laser treatments, all of which have demonstrated limited efficacy. There has been an interest in studying the effects of vitamin c and tranexamic acid in melasma. The development of fractional resurfacing has led to improvements to melasma treatment with decreased incidence of post-inflammatory hyperpigmentation; these improvements are due to the enhanced healing times and decreased inflammation as a result of the formation of microscopic columns of tissue destruction. These microscopic columns of damaged tissue are surrounded by areas of normal tissue, allowing for shorter migratory paths for the healing keratinocytes.

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with all types of melasma
    Arm Type
    Other
    Arm Description
    Fractional ablative CO2 laser : For each patient, Right side of the face : Fractional ablative CO2 laser will be followed by immediate topical application of vitamin c 3% . Left side of the face: Fractional ablative CO2 laser will be followed by immediate topical application of tranexamic acid. Fractional ablative CO2 laser sessions will be performed using the following parameters: power 8-10 W(according to the skin type), spacing 1000 μm (5.3% density), dwell time 400 μs, and stack . During the session, protective goggles will be used both by the patient and by the physician.
    Intervention Type
    Device
    Intervention Name(s)
    Fractional co2 laser
    Intervention Description
    The development of fractional resurfacing has led to improvements to melasma treatment with decreased incidence of post-inflammatory hyperpigmentation; these improvements are due to the enhanced healing times and decreased inflammation as a result of the formation of microscopic columns of tissue destruction. These microscopic columns of damaged tissue are surrounded by areas of normal tissue, allowing for shorter migratory paths for the healing keratinocytes.
    Primary Outcome Measure Information:
    Title
    Efficacy and safety of fractional CO2 laser in treatment of melasma.
    Description
    1.: For each patient, Right side of the face : Fractional ablative CO2 laser will be followed by immediate topical application of vitamin c 3% . Left side of the face: Fractional ablative CO2 laser will be followed by immediate topical application of tranexamic acid. Fractional ablative CO2 laser sessions will be performed using the following parameters: power 8-10 W (according to the skin type), spacing 1000 μm (5.3% density), dwell time 400 μs, and stack . During the session, protective goggles will be used both by the patient and by the physician. acid in the treatment of melasma. 2 .To assess the value of dermoscope in measuring of the response to treatment in melasma patients compared to clinical scoring.
    Time Frame
    1year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All types of melasma (epidermal, dermal, and mixed) will be included . Patients older than 19 years of age. Exclusion Criteria: Pregnancy, breastfeeding. Patients taking drugs that induce facial pigmentation e.g, oral contraceptive pills, or hormonal replacement therapy at the time of the study or during the past 12 months. Patients using of any topical bleaching within 1 month before recruitment. Employment of chemical peels or laser therapy during the past 6 months. Concomitant use of anticoagulants, bleeding disorders.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Khadija Qenawi, Doctor
    Phone
    +201140109931
    Email
    diganova796@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Khadija Qenawi, Doctor
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Hanan Ahmed, Professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Reham Maher, Professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21142733
    Citation
    Neeley MR, Pearce FB, Collawn SS. Successful treatment of malar dermal melasma with a fractional ablative CO(2) laser in a patient with type V skin. J Cosmet Laser Ther. 2010 Dec;12(6):258-60. doi: 10.3109/14764172.2010.538412.
    Results Reference
    background
    PubMed Identifier
    24858737
    Citation
    Jalaly NY, Valizadeh N, Barikbin B, Yousefi M. Low-power fractional CO(2) laser versus low-fluence Q-switch 1,064 nm Nd:YAG laser for treatment of melasma: a randomized, controlled, split-face study. Am J Clin Dermatol. 2014 Aug;15(4):357-63. doi: 10.1007/s40257-014-0080-x.
    Results Reference
    background
    PubMed Identifier
    35122202
    Citation
    Lai D, Zhou S, Cheng S, Liu H, Cui Y. Laser therapy in the treatment of melasma: a systematic review and meta-analysis. Lasers Med Sci. 2022 Jun;37(4):2099-2110. doi: 10.1007/s10103-022-03514-2. Epub 2022 Feb 5.
    Results Reference
    background

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    Fractional co2 Laser Followed by Either Vitamin c or Tranexamic Acid in Treatment of Melasma.

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