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Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream vs Tacrolimus Alone in Vitiligo

Primary Purpose

Stable Vitiligo

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fractional carbon dioxide laser
Tacrolimus Oint 0.03%
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Vitiligo focused on measuring vitiligo, fractional carbon dioxide laser, tacrolimus, drug delivery

Eligibility Criteria

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

Inclusion criteria:

  • Patients with stable vitiligo for at least 6 months, stability being defined as no eruption of fresh lesions and no extension of pre-existing lesions.
  • Age ≧ 12 years.
  • Symmetrical vitiligo.
  • Three month treatment-free period.

Exclusion criteria:

  • Patients younger than 12 years of age.
  • Non-stable lesions.
  • Non-symmetrical vitiligo.
  • Patients currently on other lines of treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment A

    Treatment B

    Arm Description

    Combination treatment of fractional carbon dioxide laser monthly sessions and topical tacrolimus 0.03% daily application (Tacrolimus Oint 0.03%)

    Monotherapy with only topical tacrolimus 0.03% daily intervention: Tacrolimus Oint 0.03%

    Outcomes

    Primary Outcome Measures

    repigmentation
    reduction in Vitiligo Area Scoring Index of lesions

    Secondary Outcome Measures

    Full Information

    First Posted
    May 12, 2018
    Last Updated
    September 11, 2018
    Sponsor
    Kasr El Aini Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03535051
    Brief Title
    Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream vs Tacrolimus Alone in Vitiligo
    Official Title
    The Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream Versus Topical Tacrolimus Alone in Stable Vitiligo: a Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    January 1, 2017 (Actual)
    Study Completion Date
    February 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kasr El Aini Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    The aim the clinical trial was to find out whether fractional CO₂ laser sessions in combination with application of daily topical tacrolimus 0.03% would enhance the action of the drug and pose as a possible combination treatment option for stable vitiligo lesions. This combination treatment was applied to one side of the body and the response was compared to the response of the lesions on the other side of the body to daily topical tacrolimus 0.03% alone, which was used as control.
    Detailed Description
    Each patient included in the study received treatment A on the lesions on one side of his/her body, and treatment B on the other side. Treatment A included 4 monthly sessions of fractional CO₂ laser on the lesions plus application of topical tacrolimus 0.03% (Tarolimus) on the lesions 6 hours after each session and twice daily in between the sessions and for 1 month after the last session. Treatment B included only the application of topical tacrolimus 0.03% (Tarolimus) on the lesions twice daily for 5 months. Fractional laser The device used was DEKA, SmartXide DOT (Dermal Optical Thermolysis), Italy fractional Carbon Dioxide Laser (fig. 8). This device is an ablative fractional 10,6000 nm CO² Laser with variable pulse duration (0.2-2 ms), 350-μm beam spot size, scanner area of 15x15 mm and penetration depth between 200 to 1,500 μm. Tacrolimus ointment 0.03% (Tarolimus) Applied on the lesions treated by fractional CO² laser 6 hours after each laser session, then twice daily in between the sessions and 1 month after the last session. Applied on the lesions on the other half of the body (not treated with fractional CO² laser) twice daily for 4 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stable Vitiligo
    Keywords
    vitiligo, fractional carbon dioxide laser, tacrolimus, drug delivery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    A total of 152 lesions in different areas of the body were evaluated in the study. Seventy six lesions received the combination treatment and 76 received topical tacrolimus alone. Forty six lesions were in the head and neck region, 40 were acral in location, 36 were in the upper and lower limbs, 22 lesions were over bony prominences and 8 lesions were present on the trunk.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment A
    Arm Type
    Experimental
    Arm Description
    Combination treatment of fractional carbon dioxide laser monthly sessions and topical tacrolimus 0.03% daily application (Tacrolimus Oint 0.03%)
    Arm Title
    Treatment B
    Arm Type
    Active Comparator
    Arm Description
    Monotherapy with only topical tacrolimus 0.03% daily intervention: Tacrolimus Oint 0.03%
    Intervention Type
    Device
    Intervention Name(s)
    fractional carbon dioxide laser
    Other Intervention Name(s)
    fractional CO2 laser
    Intervention Description
    Monthly fractional carbon dioxide laser sessions
    Intervention Type
    Drug
    Intervention Name(s)
    Tacrolimus Oint 0.03%
    Other Intervention Name(s)
    Tacrolimus Oint 0.03% (Tarolimus)
    Intervention Description
    topical daily tacrolimus ointment application
    Primary Outcome Measure Information:
    Title
    repigmentation
    Description
    reduction in Vitiligo Area Scoring Index of lesions
    Time Frame
    5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Patients with stable vitiligo for at least 6 months, stability being defined as no eruption of fresh lesions and no extension of pre-existing lesions. Age ≧ 12 years. Symmetrical vitiligo. Three month treatment-free period. Exclusion criteria: Patients younger than 12 years of age. Non-stable lesions. Non-symmetrical vitiligo. Patients currently on other lines of treatment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ola M AbuZeid, MD
    Organizational Affiliation
    Kasr Al Aini dermatology department
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Dina ElSharkawy, MD
    Organizational Affiliation
    Kasr Al Aini dermatology department
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream vs Tacrolimus Alone in Vitiligo

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