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Different Dermatological Approaches the Treatment of Melasma

Primary Purpose

Melasma

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

About this trial

This is an interventional treatment trial for Melasma

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • -Subjects presented with melasma.
  • Age 20-40 years old.
  • Melasma persisting for more than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents.

Exclusion Criteria:

  • -History of photosensitivity, keloids, hypertrophic scarring and post- inflammatory hyperpigmentation.
  • Pregnancy and lactation.
  • Subjects with local inflammatory skin disorder or active herpes infection at the site of procedure.
  • Subjects with history of medical diseases which contraindicate cryosurgery such as; cold intolerance, cold urticaria, Raynaud's disease and history of allergic reactions to cryosurgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    G I A (right side): will be treated by chemical peeling

    G I B(left side):will be treated by cryopeeling

    G II A (right side): will be treated by chemical peeling

    G II B (left side):will be treated by tranexemic acid

    Arm Description

    right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).

    left side of the patient's face will be treated by cryopeeling using Liquid Nitrogen.

    right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).

    left side of patient's face will be treated by tranexemic acid(cyclokapron)

    Outcomes

    Primary Outcome Measures

    melasma area and severity index (MASI)
    Clinical evaluation of melasma severity will be done by melasma area severity index (MASI) every session and at the end of treatment. No response, no improvement. Mild response, <25% improvement. Moderate response, 25% to < 50% improvement. Good response, 50% to < 75% improvement. Very good response, >75% improvement.
    photo of the patient
    photo of the patient before and after treatment
    Biopsy
    A punch biopsy will be taken from affected area for histipathological examination

    Secondary Outcome Measures

    Full Information

    First Posted
    April 1, 2019
    Last Updated
    January 10, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03923062
    Brief Title
    Different Dermatological Approaches the Treatment of Melasma
    Official Title
    Different Dermatological Approaches in Treatment of Melasma: A Split Face Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2020 (Anticipated)
    Primary Completion Date
    October 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2020 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To compare the efficacy and safety of cryopeeling (using Liquid Nitrogen) and tranexemic acid (cyclokapron) versus chemical peeling (using TCA 20%) in treatment of melasma.
    Detailed Description
    Melasma is a common, acquired, circumscribed hypermelanosis of the sun-exposed skin, It presents as symmetric, hyperpigmented macules having irregular, serrated, and geographic borders , The most common locations are the cheeks, upper lips, the chin and the forehead, but other sun-exposed areas may also be occasionally involved . Studies has indicated the role of several risk factors such as genetics, sunlight, age, gender, hormones, pregnancy, thyroid dysfunction, cosmetics and medications . Histologic features of melasma include an increase in the content of both epidermal and dermal melanin, but the quantity varies with the intensity of hyperpigmentation. In addition, most studies show no quantitative increase in melanocytes; however, the cells are enlarged with prominent and elongated dendrites and more abundant melanosomes. Additional features of the involved skin include solar elastosis and increased mast cells, dermal blood vessels, and expression of vascular endothelial growth factor. Commonly used topical agents for the treatment of melasma include hydroquinone, azelaic acid, kojic acid, glycolic acid, salicylic acid and tretinoin. Of these treatments, hydroquinone remains the gold standard .Second-line treatments, such as chemical peels and lasers, are efficacious in some patients . Chemical peeling is the application of a chemical agent to the skin, which causes the controlled destruction of a part or of the entire epidermis with or without the dermis, leading to exfoliation and removal of superficial lesions, followed by regeneration of new epidermal and dermal tissues [khunger, 2008]. The mechanism of action in melasma is the removal of unwanted melanin via controlled chemical burn of the skin . Trichloroacetic acid has been used as a peeling agent for a long time and is still the most effective and safest agent for medium peeling, Its depth of penetration depends on the TCA concentration and on the preparation of the skin, specially the degreasing. Between 10% and 30% concentration is considered a superficial peel; above 30% provides a medium-depth peel. Cryopeeling is a technique that uses cryotherapy in a diffuse manner throughout the skin region affected by sun damage in order to promote cell renewal and desquamation, with possible benefits in the appearance of new lesions caused by photodamage. Up to the investigator's knowledge, few studies were performed evaluating such technique. Recently, trans-4-(Aminomethyl) cyclohexanecarboxylic acid, or tranexamic acid (TA), has been proposed as a new treatment for melasma.The main mechanism of the hypopigmentant effects of TA is due to its antiplasmin activity .In addition, TA is similar to tyrosine in a portion of its structure, which can inhibit tyrosinase competitively .Also, Plasmin transforms the vascular endothelial growth factor (VEGF) into a diffusing form, and histological examination showed that TA plays an important role in the reduction of erythema and vascularities and the number of mast cell in the dermis.Various forms of TA are used orally, topically and as a microinjection for the treatment of melasma.

    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
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    G I A (right side): will be treated by chemical peeling
    Arm Type
    Experimental
    Arm Description
    right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).
    Arm Title
    G I B(left side):will be treated by cryopeeling
    Arm Type
    Experimental
    Arm Description
    left side of the patient's face will be treated by cryopeeling using Liquid Nitrogen.
    Arm Title
    G II A (right side): will be treated by chemical peeling
    Arm Type
    Experimental
    Arm Description
    right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).
    Arm Title
    G II B (left side):will be treated by tranexemic acid
    Arm Type
    Experimental
    Arm Description
    left side of patient's face will be treated by tranexemic acid(cyclokapron)
    Intervention Type
    Device
    Intervention Name(s)
    chemicalpeeling
    Other Intervention Name(s)
    chemical peeling using Trichloroacetic acid 20%
    Intervention Description
    Cleansing and degreasing the face with alcohol . The patients must be sitting at an angle of 45. A 2 × 2 cm cotton gauze will be used to apply TCA 20%. We will apply the acid from the midline to the right side of the forehead and under the right eye, covering the right cheek and perioral area. We then will wait for a few minutes and will observe the frost developing. The patient will be then allowed to wash her face.
    Intervention Type
    Device
    Intervention Name(s)
    cryopeeling
    Other Intervention Name(s)
    cryopeeling using Liquid Nitrogen
    Intervention Description
    Cryopeeling will be performed by spraying the freezing substance(Liquid Nitrogen) on the face at 1-2cm distance and moving along the affected area until freezing appear.
    Intervention Type
    Combination Product
    Intervention Name(s)
    microneedling
    Other Intervention Name(s)
    microneedling using tranxemic acid
    Intervention Description
    Tranexamic acid will be used in aconcentration of 4mg/ml ,1ml will be used fo half of the face. After gentle cleansing, topical analgesic cream will be applied over the area to be treated. The microneedles will be used, the skin will be stretched and microneedling will be carried out in vertical, horizontal, and both diagonal directions for about four to five times. Tranexamic acid, 0.5 to 1 ml (4 mg/mL), will be applied over this area, and the procedure will be repeated four to five times in the above-said directions
    Primary Outcome Measure Information:
    Title
    melasma area and severity index (MASI)
    Description
    Clinical evaluation of melasma severity will be done by melasma area severity index (MASI) every session and at the end of treatment. No response, no improvement. Mild response, <25% improvement. Moderate response, 25% to < 50% improvement. Good response, 50% to < 75% improvement. Very good response, >75% improvement.
    Time Frame
    baseline
    Title
    photo of the patient
    Description
    photo of the patient before and after treatment
    Time Frame
    baseline
    Title
    Biopsy
    Description
    A punch biopsy will be taken from affected area for histipathological examination
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -Subjects presented with melasma. Age 20-40 years old. Melasma persisting for more than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents. Exclusion Criteria: -History of photosensitivity, keloids, hypertrophic scarring and post- inflammatory hyperpigmentation. Pregnancy and lactation. Subjects with local inflammatory skin disorder or active herpes infection at the site of procedure. Subjects with history of medical diseases which contraindicate cryosurgery such as; cold intolerance, cold urticaria, Raynaud's disease and history of allergic reactions to cryosurgery.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shimaa Hafez, M.B.B.CH
    Phone
    01013881659
    Ext
    0020
    Email
    shimaahafez75@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Doaa Samir, Ph.D
    Phone
    01143387171
    Ext
    0020
    Email
    doaasamir1@Yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17363223
    Citation
    Kim EH, Kim YC, Lee ES, Kang HY. The vascular characteristics of melasma. J Dermatol Sci. 2007 May;46(2):111-6. doi: 10.1016/j.jdermsci.2007.01.009. Epub 2007 Mar 23.
    Results Reference
    background
    PubMed Identifier
    18631207
    Citation
    Hexsel D, Rodrigues TC, Dal'Forno T, Zechmeister-Prado D, Lima MM. Melasma and pregnancy in southern Brazil. J Eur Acad Dermatol Venereol. 2009 Mar;23(3):367-8. doi: 10.1111/j.1468-3083.2008.02885.x. Epub 2008 Jul 7. No abstract available.
    Results Reference
    background
    PubMed Identifier
    21920241
    Citation
    Sheth VM, Pandya AG. Melasma: a comprehensive update: part I. J Am Acad Dermatol. 2011 Oct;65(4):689-697. doi: 10.1016/j.jaad.2010.12.046.
    Results Reference
    background
    PubMed Identifier
    16533230
    Citation
    Moin A, Jabery Z, Fallah N. Prevalence and awareness of melasma during pregnancy. Int J Dermatol. 2006 Mar;45(3):285-8. doi: 10.1111/j.1365-4632.2004.02470.x.
    Results Reference
    background
    PubMed Identifier
    21920242
    Citation
    Sheth VM, Pandya AG. Melasma: a comprehensive update: part II. J Am Acad Dermatol. 2011 Oct;65(4):699-714. doi: 10.1016/j.jaad.2011.06.001.
    Results Reference
    background
    PubMed Identifier
    23378706
    Citation
    Sarkar R, Bansal S, Garg VK. Chemical peels for melasma in dark-skinned patients. J Cutan Aesthet Surg. 2012 Oct;5(4):247-53. doi: 10.4103/0974-2077.104912.
    Results Reference
    background
    PubMed Identifier
    11457690
    Citation
    Monheit GD, Chastain MA. Chemical peels. Facial Plast Surg Clin North Am. 2001 May;9(2):239-55, viii.
    Results Reference
    background
    PubMed Identifier
    28283893
    Citation
    Perper M, Eber AE, Fayne R, Verne SH, Magno RJ, Cervantes J, ALharbi M, ALOmair I, Alfuraih A, Nouri K. Tranexamic Acid in the Treatment of Melasma: A Review of the Literature. Am J Clin Dermatol. 2017 Jun;18(3):373-381. doi: 10.1007/s40257-017-0263-3.
    Results Reference
    background
    PubMed Identifier
    22329442
    Citation
    Na JI, Choi SY, Yang SH, Choi HR, Kang HY, Park KC. Effect of tranexamic acid on melasma: a clinical trial with histological evaluation. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):1035-9. doi: 10.1111/j.1468-3083.2012.04464.x. Epub 2012 Feb 13.
    Results Reference
    background
    PubMed Identifier
    26955108
    Citation
    Sharma YK, Gupta A. Some Other Serendipitous Discoveries in Dermatology. Indian J Dermatol. 2016 Jan-Feb;61(1):95-6. doi: 10.4103/0019-5154.174045. No abstract available.
    Results Reference
    background

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    Different Dermatological Approaches the Treatment of Melasma

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