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
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
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
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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