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
About this trial
This is an interventional treatment trial for Vitiligo Vulgaris
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.
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
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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