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Bimatoprost 0.03% Solution With NB-UVB Versus Their Use With Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo

Primary Purpose

Generalized Vitiligo

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bimatoprost 0.03% ophthalmic solution
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Vitiligo

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients older than 12.
  2. Patients with non-segmental vitiligo.
  3. Lesions stable for at least one year.
  4. Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.
  5. No sex or site predilection.
  6. Bilateral and symmetrical lesions with maximum size of 10×10 cm.

Exclusion Criteria:

  1. Patients with active infection.
  2. Patients with sensitivity to bimatoprost or photosensitivity.
  3. Patients with history or active skin cancer.
  4. Pregnant or lactating females.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Generalized vitiligo patients

    Arm Description

    Each patient with generalized vitiligo will be subjected to the following: One side will be treated by narrow band ultraviolet rays sessions twice weekly for 3 months + topical bimatoprost 0.03% ophthalmic solution solution twice daily ( 1 drop for each 2 cm2 ) and the other side will be treated by topical bimatoprost 0.03% ophthalmic solution twice daily ( 1 drop for each 2 cm2 ) + narrow band ultraviolet rays sessions twice weekly for 3 months + 10.600-nm fractional carbon dioxide laser sessions twice monthly for 3 months.

    Outcomes

    Primary Outcome Measures

    Repigmentation of skin lesions
    Patients will be followed up by two blind dermatologists after 3 months to detect: The percent of repigmentation: that will be subjectively rated with a previously reported scoring system: < 25% repigmentation (poor). 25-50% repigmentation (fair). 50-75% repigmentation (good). -> 75% repigmentation (excellent).
    Frequency and types of side effects
    Frequency and types of side effects.

    Secondary Outcome Measures

    Vitiligo area scoring index score
    Vitiligo area scoring index score percent change will be calculated by subtracting the pre- procedure vitiligo area scoring index score from the post-procedure vitiligo area scoring index score and dividing by the pre-procedure vitiligo area scoring index score.
    Patient satisfaction
    The patient overall satisfaction will be assessed after 6 months according to Wong Overall satisfaction: dissatisfied neutral somewhat satisfied moderately satisfied very satisfied

    Full Information

    First Posted
    March 11, 2018
    Last Updated
    March 27, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03487042
    Brief Title
    Bimatoprost 0.03% Solution With NB-UVB Versus Their Use With Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo
    Official Title
    Bimatoprost 0.03% Solution, NB-UVB and Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2018 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (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
    Vitiligo is a chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes. It affects approximately 0.5%-2% of general population world-wide, without predilection for sex or race.Vitiligo can be classified into segmental or non-segmental. Non-segmental or generalized vitiligo is the most common clinical presentation and often involves the face and acral regions. Multiple monotherapy modalities are established to treat vitiligo but the response is variable, unsatisfactory, and requiring a prolonged course. This problem is exaggerated by the multifactorial and polygenic nature of the pathomechanism of the disease. These facts pave the way to combination therapy that showed better and safe repigmentation response than monotherapy.
    Detailed Description
    Bimatoprost 0.03% ophthalmic solution is a synthetic prostaglandin F2 alpha analog that is approved for the treatment of glaucoma and eyelashes hypotrichosis (Lee et al, 2017). Cutaneous hyperpigmentation of the treated sites has been reported as a side effect with this agent. Phototherapy (narrow band ultraviolet B (NB-UVB)) of wavelength 308 nm, is considered as a successful method of treatment of vitiligo. The cytotoxic T-cells accountable for the destruction of melanocytes and disappearance of melanin are eliminated by phototherapy through apoptosis (diffuse repigmentation) and UVB does stimulate melanocytic proliferation and their migration to the epidermis from nearby follicular units (follicular repigmentation) and perilesional active melanocytes (marginal repigmentation). In recent years, fractional carbon dioxide laser has been introduced as an add-on treatment for vitiligo. It represents a new modality for skin resurfacing based on the theory of fractional photothermolysis. The beneficial effect of fractional carbon dioxide laser on vitiligo is the release of cytokines and growth factors that act as mitogens for melanogenesis. It also alters the skin barrier, which results in increased penetration of topical drugs and ultraviolet (UV) radiation, so it can be used in combination therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Generalized Vitiligo

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Generalized vitiligo patients
    Arm Type
    Experimental
    Arm Description
    Each patient with generalized vitiligo will be subjected to the following: One side will be treated by narrow band ultraviolet rays sessions twice weekly for 3 months + topical bimatoprost 0.03% ophthalmic solution solution twice daily ( 1 drop for each 2 cm2 ) and the other side will be treated by topical bimatoprost 0.03% ophthalmic solution twice daily ( 1 drop for each 2 cm2 ) + narrow band ultraviolet rays sessions twice weekly for 3 months + 10.600-nm fractional carbon dioxide laser sessions twice monthly for 3 months.
    Intervention Type
    Drug
    Intervention Name(s)
    Bimatoprost 0.03% ophthalmic solution
    Other Intervention Name(s)
    Narrow band ultraviolet rays B, Fractional carbon dioxide laser
    Intervention Description
    Each patient will be subjected to the following: One side will be treated by narrow band ultraviolet rays B sessions twice weekly for 3 months + topical bimatoprost 0.03% solution twice daily ( 1 drop for each 2 cm2 ) and the other side will be treated by topical bimatoprost 0.03% twice daily ( 1 drop for each 2 cm2 ) + narrow band ultraviolet rays B sessions twice weekly for 3 months + 10.600-nm fractional carbon dioxide laser sessions twice monthly for 3 months. Patients' Evaluation: The recruited patients will be subjected to: A) Full history taking. B) General clinical examination. C) Dermatological examination of the skin lesions. D) Vitiligo area scoring index score will be calculated for each patient E) Clinical photographs will be taken at baseline, after each month during treatment and after the end of treatment by 3 months. F) A skin biopsy from the treated lesions for histochemical examination. F) Dermoscopic evaluation of the treated sites every 2 weeks.
    Primary Outcome Measure Information:
    Title
    Repigmentation of skin lesions
    Description
    Patients will be followed up by two blind dermatologists after 3 months to detect: The percent of repigmentation: that will be subjectively rated with a previously reported scoring system: < 25% repigmentation (poor). 25-50% repigmentation (fair). 50-75% repigmentation (good). -> 75% repigmentation (excellent).
    Time Frame
    3 months
    Title
    Frequency and types of side effects
    Description
    Frequency and types of side effects.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Vitiligo area scoring index score
    Description
    Vitiligo area scoring index score percent change will be calculated by subtracting the pre- procedure vitiligo area scoring index score from the post-procedure vitiligo area scoring index score and dividing by the pre-procedure vitiligo area scoring index score.
    Time Frame
    3 months
    Title
    Patient satisfaction
    Description
    The patient overall satisfaction will be assessed after 6 months according to Wong Overall satisfaction: dissatisfied neutral somewhat satisfied moderately satisfied very satisfied
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients older than 12. Patients with non-segmental vitiligo. Lesions stable for at least one year. Patients who were unresponsive to medical treatment or photo therapy for at least 3 months. No sex or site predilection. Bilateral and symmetrical lesions with maximum size of 10×10 cm. Exclusion Criteria: Patients with active infection. Patients with sensitivity to bimatoprost or photosensitivity. Patients with history or active skin cancer. Pregnant or lactating females.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amira Abdel-Motaleb
    Phone
    01005263721
    Email
    Amiraali21@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yasmin Tawfik
    Phone
    01006033331

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25596811
    Citation
    Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.
    Results Reference
    background
    PubMed Identifier
    21839315
    Citation
    Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.
    Results Reference
    background
    PubMed Identifier
    28834191
    Citation
    Abdelghani R, Ahmed NA, Darwish HM. Combined treatment with fractional carbon dioxide laser, autologous platelet-rich plasma, and narrow band ultraviolet B for vitiligo in different body sites: A prospective, randomized comparative trial. J Cosmet Dermatol. 2018 Jun;17(3):365-372. doi: 10.1111/jocd.12397. Epub 2017 Aug 20.
    Results Reference
    background
    PubMed Identifier
    28744094
    Citation
    Lee D, Mantravadi AV, Myers JS. Patient considerations in ocular hypertension: role of bimatoprost ophthalmic solution. Clin Ophthalmol. 2017 Jul 10;11:1273-1280. doi: 10.2147/OPTH.S118689. eCollection 2017.
    Results Reference
    background
    PubMed Identifier
    27550870
    Citation
    Bagherani N, Smoller BR. Efficacy of bimatoprost in the treatment of non-facial vitiligo. Dermatol Ther. 2017 Mar;30(2). doi: 10.1111/dth.12409. Epub 2016 Aug 23. No abstract available.
    Results Reference
    background
    PubMed Identifier
    29123631
    Citation
    Salah Eldin MM, Sami NA, Aly DG, Hanafy NS. Comparison Between (311-312 nm) Narrow Band Ultraviolet-B Phototherapy and (308 nm) Monochromatic Excimer Light Phototherapy in Treatment of Vitiligo: A Histopathological Study. J Lasers Med Sci. 2017 Summer;8(3):123-127. doi: 10.15171/jlms.2017.22. Epub 2017 Jun 27.
    Results Reference
    background
    PubMed Identifier
    24771971
    Citation
    Omi T, Numano K. The Role of the CO2 Laser and Fractional CO2 Laser in Dermatology. Laser Ther. 2014 Mar 27;23(1):49-60. doi: 10.5978/islsm.14-RE-01.
    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
    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

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    Bimatoprost 0.03% Solution With NB-UVB Versus Their Use With Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo

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