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The Effect of Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or NB-UVB in Stable Generalized Vitiligo

Primary Purpose

Vitiligo Vulgaris

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tacrolimus ointment
calcipotriol ointment
NB-UVB
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo Vulgaris

Eligibility Criteria

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

Inclusion Criteria:

  • patients with stable vitiligo
  • nonsegmental vitiligo will be recruited
  • A patient reporting no new lesions, no progression of existing lesions, and absence of Koebner phenomenon during the previous year

Exclusion Criteria:

  1. Patients with active infection.
  2. Reported histories of koebnerization.
  3. History of keloid formation or hypertrophic scars.
  4. Pregnant or lactating females.
  5. Bleeding tendency.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Group A (Tacrolimus group):

    Group B (Calcipotriol group):

    Group C (NB-UVB group):

    Arm Description

    fractional CO2 laser therapy and Tacrolimus ointment 1

    fractional CO2 laser therapy and Calcipotriol ointment

    fractional CO2 laser therapy and NB-UVB twice weekly

    Outcomes

    Primary Outcome Measures

    1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016).
    G0, < 25% repigmentation (poor) G1, 25-50% repigmentation (fair) G2, 50-75% repigmentation (good) G3 > 75% repigmentation (excellent).

    Secondary Outcome Measures

    The VASI percent change
    The VASI percent change will be calculated by subtracting the pre- procedure VASI score from the post-procedure VASI score and dividing by the pre-procedure VASI score.

    Full Information

    First Posted
    July 27, 2017
    Last Updated
    July 30, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03234673
    Brief Title
    The Effect of Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or NB-UVB in Stable Generalized Vitiligo
    Official Title
    The Effect of Preceding Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or With NB-UVB in the Treatment of Stable Generalized Vitiligo
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2017 (Anticipated)
    Primary Completion Date
    August 2018 (Anticipated)
    Study Completion Date
    January 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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well circumscribed depigmented macules and patches that occur secondary to selective destruction of melanocytes (Zhang et al., 2009). Generalized vitiligo is the most common clinical presentation and often involves the face and acral regions (Alikhan et al., 2011).
    Detailed Description
    Combined vitiligo treatments have been found to be superior to monotherapies regarding efficacy, early response and safety (Kandaswamy et al., 2013). Fractionated lasers represent a new modality for skin resurfacing based on the theory of fractional photothermolysis introduced by Manstein et al (2004). These lasers were shown to be efficient in treating facial photo aging changes as well as scars, and have an improved safety and recovery profile compared with traditional CO2 laser resurfacing. Fractionated lasers do not ablate the entire epidermis and thereafter leave intact skin between coagulated necrotic columns. This characteristic facilitates the skin healing process (Bogdan et al., 2010)

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A (Tacrolimus group):
    Arm Type
    Experimental
    Arm Description
    fractional CO2 laser therapy and Tacrolimus ointment 1
    Arm Title
    Group B (Calcipotriol group):
    Arm Type
    Experimental
    Arm Description
    fractional CO2 laser therapy and Calcipotriol ointment
    Arm Title
    Group C (NB-UVB group):
    Arm Type
    Experimental
    Arm Description
    fractional CO2 laser therapy and NB-UVB twice weekly
    Intervention Type
    Drug
    Intervention Name(s)
    Tacrolimus ointment
    Other Intervention Name(s)
    tarolimus ointment
    Intervention Description
    3 sessions of fractional CO2 laser one month apart Patients will start treatment Tarolimus ointment twice daily for 3 months.
    Intervention Type
    Drug
    Intervention Name(s)
    calcipotriol ointment
    Other Intervention Name(s)
    calcipoheal
    Intervention Description
    3 sessions of fractional CO2 laser one month apart Patients will start treatment Calcipotriol ointment twice daily for 3 months.
    Intervention Type
    Drug
    Intervention Name(s)
    NB-UVB
    Other Intervention Name(s)
    narrow band ultraviolet rays B
    Intervention Description
    3 sessions of fractional CO2 laser one month apart Patients will start treatment NB-UVB phototherapy twice weekly for 3 months
    Primary Outcome Measure Information:
    Title
    1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016).
    Description
    G0, < 25% repigmentation (poor) G1, 25-50% repigmentation (fair) G2, 50-75% repigmentation (good) G3 > 75% repigmentation (excellent).
    Time Frame
    up to 3 months
    Secondary Outcome Measure Information:
    Title
    The VASI percent change
    Description
    The VASI percent change will be calculated by subtracting the pre- procedure VASI score from the post-procedure VASI score and dividing by the pre-procedure VASI score.
    Time Frame
    every month for 3 months
    Other Pre-specified Outcome Measures:
    Title
    - Frequency and types of side effects.
    Description
    pain, scarring, hyperpigmentation
    Time Frame
    3 months
    Title
    - Patient satisfaction. The patient overall satisfaction will be assessed after 6 months according to Wong and Vasconez (2011). Overall satisfaction:
    Description
    dissatisfied neutral somewhat satisfied moderately satisfied very satisfied
    Time Frame
    3 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 with stable vitiligo nonsegmental vitiligo will be recruited A patient reporting no new lesions, no progression of existing lesions, and absence of Koebner phenomenon during the previous year Exclusion Criteria: Patients with active infection. Reported histories of koebnerization. History of keloid formation or hypertrophic scars. Pregnant or lactating females. Bleeding tendency.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    yasmin tawfik, MD
    Phone
    01006033331
    Email
    dr.yasminmostawfik@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    reham maher abdel gaber
    Phone
    01005043777
    Email
    rehamaher707@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    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
    result
    PubMed Identifier
    23919018
    Citation
    Kandaswamy S, Akhtar N, Ravindran S, Prabhu S, Shenoi SD. Phototherapy in Vitiligo: Assessing the Compliance, Response and Patient's Perception about Disease and Treatment. Indian J Dermatol. 2013 Jul;58(4):325. doi: 10.4103/0019-5154.113944.
    Results Reference
    result
    PubMed Identifier
    19787413
    Citation
    Bogdan Allemann I, Kaufman J. Fractional photothermolysis--an update. Lasers Med Sci. 2010 Jan;25(1):137-44. doi: 10.1007/s10103-009-0734-8.
    Results Reference
    result
    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
    result

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    The Effect of Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or NB-UVB in Stable Generalized Vitiligo

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