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Effect Of Topical Prostaglandin F2α Analogs,Fractional CO2 Laser, Excimer Laser Or Their Combination In Treatment Of Vitiligo

Primary Purpose

Vitiligo, Excimer Laser, Fractional CO2 Laser

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Topical travoprost 0.004% solution
Fractional CO2 laser
Excimer laser
Combination therapy
Excimer laser and travoprost
fractional CO2 laser and topical travoprost
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients older than 12 years.
  2. Patients with generalized non-segmental vitiligo.
  3. No previous treatment for vitiligo in the last 1 month.
  4. Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.

Exclusion Criteria:

  1. Patients with sensitivity to travoprost.
  2. Patients with photosensitivity.
  3. Patients with history or active skin cancer.
  4. No other dermatological or systemic diseases.
  5. Active infections .
  6. Pregnant or lactating females.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    vitiligo patients

    Arm Description

    Thirty Patients complaining of generalized non segmental vitiligo will be recruited in this study. They will be chosen from the attendants of the out-patient clinics of Dermatology, Assiut university hospital. six patches will be selected in each patient.

    Outcomes

    Primary Outcome Measures

    clinical improvement through VASI score
    VASI score will be calculated for each patient at start, every 4 weeks and 6 months after the last session. VASI = ∑ all treated sites [number of hand units] X [% residual depigmentation].

    Secondary Outcome Measures

    Patients satisfaction
    according to the following scale: dissatisfied neutral somewhat satisfied moderately satisfied very satisfied
    percent of repigmentation
    The percent of repigmentation will be calculated every 4 weeks of treatment and 6 months after the last session by a scoring system . < 25% repigmentation (poor response). 25-50% repigmentation (fair response). 50-75% repigmentation (good response). > 75% repigmentation (excellent response).
    Histopathological evaluation
    Skin biopsy will be taken from the treated lesions after treatment, Hematoxylin and eosin-stained slides will be examined microscopically to evaluate the epidermal and dermal pathological changes: (1) evaluation of dermal perivascular inflammatory infiltrate density; (2) signs of pigmentation in the form of residual melanin in epidermis or dermal melanophages .

    Full Information

    First Posted
    September 26, 2020
    Last Updated
    October 19, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04577027
    Brief Title
    Effect Of Topical Prostaglandin F2α Analogs,Fractional CO2 Laser, Excimer Laser Or Their Combination In Treatment Of Vitiligo
    Official Title
    Safety And Efficacy Of Topical Prostaglandin F2α Analogs In Combination With Fractional CO2 Laser And 308 Excimer Light In Treatment Of Vitiligo
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    January 1, 2022 (Anticipated)
    Study Completion Date
    April 1, 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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Vitiligo is a chronic disease with an unpredictable clinical course, characterized by the appearance of white macules and patches on the skin and mucous membranes due to the disappearance of melanocytes in the affected area. It affects approximately 0.5% - 2% of the population worldwide and may occur at any age. Vitiligo is caused by a dynamic interplay between genetic and environmental risks that initiates an autoimmune attack on melanocytes in the skin.
    Detailed Description
    The treatment of vitiligo has been a challenge for dermatologists. Recent reports have highlighted darkening of iris, and eyelashes and periocular hyperpigmentation induced by prostaglandin F2α analogues used for the treatment of glaucoma (as travoprost). Extrapolating these findings in the treatment of vitiligo. The beneficial effect of fractional CO2 laser on vitiligo is postulated to come from the release of cytokines and growth factors that act as mitogens for melanogenesis . The preceding laser also alters the skin barrier, which results in increased penetration of topical drugs and ultraviolet (UV) radiation. 308 nm excimer laser is a monochromatic, target type treatment and allows the delivery of higher fluences to the lesions and avoids damage to the surrounding normal skin resulting in a faster and more effective pigmentation with minimal side effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitiligo, Excimer Laser, Fractional CO2 Laser

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Masking Description
    no masking
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    vitiligo patients
    Arm Type
    Experimental
    Arm Description
    Thirty Patients complaining of generalized non segmental vitiligo will be recruited in this study. They will be chosen from the attendants of the out-patient clinics of Dermatology, Assiut university hospital. six patches will be selected in each patient.
    Intervention Type
    Drug
    Intervention Name(s)
    Topical travoprost 0.004% solution
    Intervention Description
    30 Patches treated with Topical Travoprost 0.004% solution: Topical travoprost 0.004% solution once daily (1 drop for each 2.5 x 2.5 cm2) for 3 months.
    Intervention Type
    Device
    Intervention Name(s)
    Fractional CO2 laser
    Intervention Description
    30 Patches treated with Fractional CO2 laser: Fractional CO2 laser sessions twice monthly for 3 months, parameters settings as follows: Energy\ dot 100mj, pulse duration 5ms, density level 17, pattern: array, depth level 1, 2 passes used
    Intervention Type
    Device
    Intervention Name(s)
    Excimer laser
    Intervention Description
    30 Patches treated with Excimer laser: Excimer laser sessions will be repeated twice weekly on the selected patch only, The starting dose will be 200 mj /cm2, an increase of 100 mJ/cm2 in the following session if no erythema appears, an increase of 50 mJ/cm2 every session till the appearance of erythema that lasts 24 hours or more.
    Intervention Type
    Other
    Intervention Name(s)
    Combination therapy
    Intervention Description
    30 Patches treated with Combination therapy: Fractional CO2 laser twice per month followed by application of topical travoprost 0,004% daily and excimer laser twice weekly .
    Intervention Type
    Other
    Intervention Name(s)
    Excimer laser and travoprost
    Intervention Description
    30 Patches treated with Excimer laser twice weekly and topical travoprost once daily for 3 months
    Intervention Type
    Other
    Intervention Name(s)
    fractional CO2 laser and topical travoprost
    Intervention Description
    30 Patches treated with fractional CO2 laser twice monthly and topical travoprost once daily for 3 months
    Primary Outcome Measure Information:
    Title
    clinical improvement through VASI score
    Description
    VASI score will be calculated for each patient at start, every 4 weeks and 6 months after the last session. VASI = ∑ all treated sites [number of hand units] X [% residual depigmentation].
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    Patients satisfaction
    Description
    according to the following scale: dissatisfied neutral somewhat satisfied moderately satisfied very satisfied
    Time Frame
    9 months
    Title
    percent of repigmentation
    Description
    The percent of repigmentation will be calculated every 4 weeks of treatment and 6 months after the last session by a scoring system . < 25% repigmentation (poor response). 25-50% repigmentation (fair response). 50-75% repigmentation (good response). > 75% repigmentation (excellent response).
    Time Frame
    9 months
    Title
    Histopathological evaluation
    Description
    Skin biopsy will be taken from the treated lesions after treatment, Hematoxylin and eosin-stained slides will be examined microscopically to evaluate the epidermal and dermal pathological changes: (1) evaluation of dermal perivascular inflammatory infiltrate density; (2) signs of pigmentation in the form of residual melanin in epidermis or dermal melanophages .
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients older than 12 years. Patients with generalized non-segmental vitiligo. No previous treatment for vitiligo in the last 1 month. Patients who were unresponsive to medical treatment or photo therapy for at least 3 months. Exclusion Criteria: Patients with sensitivity to travoprost. Patients with photosensitivity. Patients with history or active skin cancer. No other dermatological or systemic diseases. Active infections . Pregnant or lactating females.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hatem Zidan, Prof.DR
    Phone
    01003420217
    Email
    hzma03@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yasmin Tawfik, DR

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27538097
    Citation
    Fa Y, Lin Y, Chi XJ, Shi WH, Wang JL, Guo X, Geng JH, Liu HX, Zhang FR. Treatment of vitiligo with 308-nm excimer laser: our experience from a 2-year follow-up of 979 Chinese patients. J Eur Acad Dermatol Venereol. 2017 Feb;31(2):337-340. doi: 10.1111/jdv.13917. Epub 2016 Sep 19.
    Results Reference
    background
    PubMed Identifier
    29110015
    Citation
    Kim HJ, Hong ES, Cho SH, Lee JD, Kim HS. Fractional Carbon Dioxide Laser as an "Add-on" Treatment for Vitiligo: A Meta-analysis with Systematic Review. Acta Derm Venereol. 2018 Feb 7;98(2):180-184. doi: 10.2340/00015555-2836.
    Results Reference
    background
    PubMed Identifier
    31541597
    Citation
    Khattab FM, Abdelbary E, Fawzi M. Evaluation of combined excimer laser and platelet-rich plasma for the treatment of nonsegmental vitiligo: A prospective comparative study. J Cosmet Dermatol. 2020 Apr;19(4):869-877. doi: 10.1111/jocd.13103. Epub 2019 Sep 21.
    Results Reference
    background
    PubMed Identifier
    21451378
    Citation
    Wong L, Vasconez HC. Patient satisfaction after Nd:YAG laser-assisted lipolysis. Ann Plast Surg. 2011 May;66(5):561-3. doi: 10.1097/SAP.0b013e31820b3d1e.
    Results Reference
    background
    PubMed Identifier
    29707867
    Citation
    Doghaim NN, Gheida SF, El-Tatawy RA, Mohammed Ali DA. Combination of fractional carbon dioxide laser with narrow band ultraviolet B to induce repigmentation in stable vitiligo: A comparative study. J Cosmet Dermatol. 2019 Feb;18(1):142-149. doi: 10.1111/jocd.12553. Epub 2018 Apr 30.
    Results Reference
    background

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    Effect Of Topical Prostaglandin F2α Analogs,Fractional CO2 Laser, Excimer Laser Or Their Combination In Treatment Of Vitiligo

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