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Trichloroacetic Acid (TCA) Combined With Microdermabrasion in Treatment of Melasma

Primary Purpose

Melasma

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
TCA
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma focused on measuring TCA, Chemical peeling, Microdermabrasion, Trichloroacetic acid, MELASMA, MDA

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults of 18 years and above with bilateral melasma
  2. Clinical diagnosis of melasma.
  3. Mental capacity to give informed consent.

Exclusion Criteria:

  1. Pregnant or nursing women
  2. Current use of hormonal birth control medication or any hormonal therapy
  3. History of laser or dermabrasion to the face within 9 months of study enrollment
  4. Patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar/keloids
  5. Photosensitivity.
  6. Patients with unrealistic expectations All the included patients will be subjected to detailed history taking,dermatological examination and Wood's light examination to estimate the depth (epidermal, dermal or mixed) of melasma.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group 15% concentration

    Group 20 % concentration

    Arm Description

    30 patients MDA will be done to one half of the face then TCA 15% will be applied to the whole face.

    30 patients will receive MDA to one side of the face , TCA 20% will then be applied to the whole face.

    Outcomes

    Primary Outcome Measures

    "EFFICACY of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma "
    To detect the efficacy of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma. Clinical photographs: Front, right and left views of face of each patient will be photographed at baseline, every two weeks and one month after the last session with and high resolution digital camera in natural light.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 18, 2021
    Last Updated
    March 27, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04823520
    Brief Title
    Trichloroacetic Acid (TCA) Combined With Microdermabrasion in Treatment of Melasma
    Official Title
    Trichloroacetic Acid (TCA) Combined With Microdermabrasion in Treatment of Melasma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    April 1, 2022 (Anticipated)
    Study Completion Date
    September 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    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
    To detect the efficacy and safety of combined TCA and MDA in treating melasma. To compare the efficacy and safety of using different TCA concentrations (15% & 20%) alone and in combination with MDA in treatment of melasma.
    Detailed Description
    Melasma is a common, acquired hypermelanosis that occurs in sun exposed areas, mostly on the face, occasionally on the neck, and rarely on the forearms. Melasma is generally a clinical diagnosis consisting of symmetric reticulated hypermelanosis in three predominant facial patterns: Centro facial, malar, and mandibular The major clinical pattern in 50-80% of cases is the Centro facial pattern, which affects the forehead, nose, and upper lip . The malar pattern is restricted to the malar cheeks on the face, while mandibular melasma is present on the jawline and chin . A newer pattern termed extra-facial melasma can occur on non-facial body parts, including the neck, sternum, forearms, and upper extremities . Using the Wood's light examination, melasma can be classified into four major histological types depending upon the depth of pigment deposition:The epidermal type, in which the pigmentation is intensified under Wood's light, is the most common type. The epidermal type is the most responsive to treatment. Key etiologic factors include a genetic predisposition, solar damage, barrier abnormalities, and unique sensitivities to hormonal changes including pregnancy, oral contraceptives, and hormone replacement therapy. Melasma is often difficult to treat, and the condition may be refractory. Despite a strong therapeutic demand, the treatment of melasma remains highly challenging with inconsistent results and almost constant relapses. The treatment of melasma should include a multimodality approach that incorporates photoprotective agents, antioxidant treatments, skin lighteners, exfoliants, and resurfacing procedures, as needed. Evidence-based studies suggest that first line therapies for melasma encompass intense photoprotection and topical lightening agents. Many depigmenting agents and other therapies such as chemical peeling are used for treating melasma, in the form of mono or combined therapy . The most commonly used peeling agents are alpha-hydroxy-acids, glycolic acid, Jessner solution, salicylic acid, trichloroacetic acid (TCA), pyruvic acid and phenol . Chemical peelings are used on a wide scale in cosmetic field including melasma treatment. They often provide clinicians with flexibility in tailoring treat- ments according to patient needs and satisfaction Chemical peelings are used on a wide scale in cosmetic field including melasma treatment. They often provide clinicians with flexibility in tailoring treat- ments according to patient needs and satisfaction Chemical peelings are used on a wide scale in cosmetic field including melasma treatment. They often provide clinicians with flexibility in tailoring treat- ments according to patient needs and satisfaction. Chemical peelings are used on a wide scale in cosmetic field including melasma treatment. They often provide clinicians with flexibility in tailoring treat- ments according to patient needs and satisfaction. Chemical peeling is a promising treatment for numerous pigmentary disorders as melasma. It aims to remove the melanin rather than the inhibition of melanocytes or melanogenesis by causing controlled necrosis and subsequent regeneration of the epidermis, apart from remodeling of collagen and elastic fibers in the dermis . TCA is widely used peeling agent in treatment of hyperpigmentation especially melasma. It is a keratolytic acid which cause precipitation of proteins and coagulation necrosis of the epidermis that leads to reepithelization with replacement of smoother skin with an even skin tone .It is not expensive, stable, not light-sensitive and does not need to be neutralized . Microdermabrasion (MDA) is a minimally invasive epidermal resurfacing procedure used to treat uneven skin tone/texture, photo aging, striae, melasma, and scars.Microdermabrasion uses a variable flow of vacuum suction to maintain contact with the skin whilst the crystals (or diamond tips) get to work by smoothing and buffing the skin's surface.The crystals (or diamond tips) cause gentle mechanical abrasion to the skin, which ultimately removes the stratum corneum layer of the epidermis. As part of the wound healing process, new epidermis forms with enhanced cosmoses. The technique is considered safe for all Fitzpatrick skin types and complications are minimal. In addition to the cosmetic benefits of MDA, studies have also shown improved skin permeability and enhanced delivery of transdermal medications dosed on an area of the skin treated with MDA. Microdermabrasion removes the stratum corneum, the outermost layer of the epidermis . MDA has also been shown to affect deeper layers of the epidermis and dermis. MDA causes a re-arrangement of melanosomes in the basal layer of the epidermis, flattening of rete ridges at the dermal-epidermal junction, increased collagen fiber density at the dermal-epidermal junction, and vascular ectasia in the reticular dermis .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melasma
    Keywords
    TCA, Chemical peeling, Microdermabrasion, Trichloroacetic acid, MELASMA, MDA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    (Group 1): 30 patients MDA will be done to one half of the face then TCA 15% will be applied to the whole face. (Group 2): 30 patients will receive MDA to one side of the face , TCA 20% will then be applied to the whole face.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 15% concentration
    Arm Type
    Active Comparator
    Arm Description
    30 patients MDA will be done to one half of the face then TCA 15% will be applied to the whole face.
    Arm Title
    Group 20 % concentration
    Arm Type
    Active Comparator
    Arm Description
    30 patients will receive MDA to one side of the face , TCA 20% will then be applied to the whole face.
    Intervention Type
    Drug
    Intervention Name(s)
    TCA
    Other Intervention Name(s)
    MIcrodermabrasion (MDA)
    Intervention Description
    All patients will receive 6 sessions at 2 weeks intervals,the half face which will recieve MDA and TCA,MDA will be done before appling TCA.
    Primary Outcome Measure Information:
    Title
    "EFFICACY of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma "
    Description
    To detect the efficacy of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma. Clinical photographs: Front, right and left views of face of each patient will be photographed at baseline, every two weeks and one month after the last session with and high resolution digital camera in natural light.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults of 18 years and above with bilateral melasma Clinical diagnosis of melasma. Mental capacity to give informed consent. Exclusion Criteria: Pregnant or nursing women Current use of hormonal birth control medication or any hormonal therapy History of laser or dermabrasion to the face within 9 months of study enrollment Patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar/keloids Photosensitivity. Patients with unrealistic expectations All the included patients will be subjected to detailed history taking,dermatological examination and Wood's light examination to estimate the depth (epidermal, dermal or mixed) of melasma.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hatem Ze mohamed, professor
    Phone
    +201003420217
    Email
    zedanhzma@aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Radwa Mo bakr, Dr
    Phone
    +201119988115
    Email
    Radwabakr2011@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    20101327
    Citation
    Bandyopadhyay D. Topical treatment of melasma. Indian J Dermatol. 2009;54(4):303-9. doi: 10.4103/0019-5154.57602.
    Results Reference
    background
    PubMed Identifier
    6787100
    Citation
    Sanchez NP, Pathak MA, Sato S, Fitzpatrick TB, Sanchez JL, Mihm MC Jr. Melasma: a clinical, light microscopic, ultrastructural, and immunofluorescence study. J Am Acad Dermatol. 1981 Jun;4(6):698-710. doi: 10.1016/s0190-9622(81)70071-9.
    Results Reference
    background
    PubMed Identifier
    20202051
    Citation
    Guinot C, Cheffai S, Latreille J, Dhaoui MA, Youssef S, Jaber K, Nageotte O, Doss N. Aggravating factors for melasma: a prospective study in 197 Tunisian patients. J Eur Acad Dermatol Venereol. 2010 Sep;24(9):1060-9. doi: 10.1111/j.1468-3083.2010.03592.x. Epub 2010 Feb 25.
    Results Reference
    background
    PubMed Identifier
    22212073
    Citation
    Tamega Ade A, Miot LD, Bonfietti C, Gige TC, Marques ME, Miot HA. Clinical patterns and epidemiological characteristics of facial melasma in Brazilian women. J Eur Acad Dermatol Venereol. 2013 Feb;27(2):151-6. doi: 10.1111/j.1468-3083.2011.04430.x. Epub 2012 Jan 3.
    Results Reference
    background
    PubMed Identifier
    11076368
    Citation
    Mandry Pagan R, Sanchez JL. Mandibular melasma. P R Health Sci J. 2000 Sep;19(3):231-4.
    Results Reference
    background
    PubMed Identifier
    22827850
    Citation
    Ritter CG, Fiss DV, Borges da Costa JA, de Carvalho RR, Bauermann G, Cestari TF. Extra-facial melasma: clinical, histopathological, and immunohistochemical case-control study. J Eur Acad Dermatol Venereol. 2013 Sep;27(9):1088-94. doi: 10.1111/j.1468-3083.2012.04655.x. Epub 2012 Jul 24.
    Results Reference
    background
    Citation
    Lapeere H, Boone B, Schepper SD.(2018) : Hypomelanosis and hypermelanosis. In: Wolff K,Goldsmith LA, Katz SI, editors.Dermatology in general medicine. 7th ed. New York: McGraw Hill. p. 635
    Results Reference
    background
    Citation
    Lebwohl M, Heymann W, Berth-Jones J. Treatment of skin disease: Comprehensive therapeutic strategies. St. Louis, MO: Mosby; 2002.
    Results Reference
    background
    PubMed Identifier
    24679999
    Citation
    Molinar VE, Taylor SC, Pandya AG. What's new in objective assessment and treatment of facial hyperpigmentation? Dermatol Clin. 2014 Apr;32(2):123-35. doi: 10.1016/j.det.2013.12.008.
    Results Reference
    background
    PubMed Identifier
    24438951
    Citation
    Jutley GS, Rajaratnam R, Halpern J, Salim A, Emmett C. Systematic review of randomized controlled trials on interventions for melasma: an abridged Cochrane review. J Am Acad Dermatol. 2014 Feb;70(2):369-73. doi: 10.1016/j.jaad.2013.07.044.
    Results Reference
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    Trichloroacetic Acid (TCA) Combined With Microdermabrasion in Treatment of Melasma

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