Effect Of Topical Prostaglandin F2α Analogs,Fractional CO2 Laser, Excimer Laser Or Their Combination In Treatment Of Vitiligo
Primary Purpose
Vitiligo, Excimer Laser, Fractional CO2 Laser
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Topical travoprost 0.004% solution
Fractional CO2 laser
Excimer laser
Combination therapy
Excimer laser and travoprost
fractional CO2 laser and topical travoprost
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo
Eligibility Criteria
Inclusion Criteria:
- Patients older than 12 years.
- Patients with generalized non-segmental vitiligo.
- No previous treatment for vitiligo in the last 1 month.
- Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.
Exclusion Criteria:
- Patients with sensitivity to travoprost.
- Patients with photosensitivity.
- Patients with history or active skin cancer.
- No other dermatological or systemic diseases.
- Active infections .
- Pregnant or lactating females.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vitiligo patients
Arm Description
Thirty Patients complaining of generalized non segmental vitiligo will be recruited in this study. They will be chosen from the attendants of the out-patient clinics of Dermatology, Assiut university hospital. six patches will be selected in each patient.
Outcomes
Primary Outcome Measures
clinical improvement through VASI score
VASI score will be calculated for each patient at start, every 4 weeks and 6 months after the last session.
VASI = ∑ all treated sites [number of hand units] X [% residual depigmentation].
Secondary Outcome Measures
Patients satisfaction
according to the following scale:
dissatisfied
neutral
somewhat satisfied
moderately satisfied
very satisfied
percent of repigmentation
The percent of repigmentation will be calculated every 4 weeks of treatment and 6 months after the last session by a scoring system .
< 25% repigmentation (poor response). 25-50% repigmentation (fair response). 50-75% repigmentation (good response). > 75% repigmentation (excellent response).
Histopathological evaluation
Skin biopsy will be taken from the treated lesions after treatment, Hematoxylin and eosin-stained slides will be examined microscopically to evaluate the epidermal and dermal pathological changes: (1) evaluation of dermal perivascular inflammatory infiltrate density; (2) signs of pigmentation in the form of residual melanin in epidermis or dermal melanophages .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04577027
Brief Title
Effect Of Topical Prostaglandin F2α Analogs,Fractional CO2 Laser, Excimer Laser Or Their Combination In Treatment Of Vitiligo
Official Title
Safety And Efficacy Of Topical Prostaglandin F2α Analogs In Combination With Fractional CO2 Laser And 308 Excimer Light In Treatment Of Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (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 a chronic disease with an unpredictable clinical course, characterized by the appearance of white macules and patches on the skin and mucous membranes due to the disappearance of melanocytes in the affected area.
It affects approximately 0.5% - 2% of the population worldwide and may occur at any age.
Vitiligo is caused by a dynamic interplay between genetic and environmental risks that initiates an autoimmune attack on melanocytes in the skin.
Detailed Description
The treatment of vitiligo has been a challenge for dermatologists. Recent reports have highlighted darkening of iris, and eyelashes and periocular hyperpigmentation induced by prostaglandin F2α analogues used for the treatment of glaucoma (as travoprost). Extrapolating these findings in the treatment of vitiligo.
The beneficial effect of fractional CO2 laser on vitiligo is postulated to come from the release of cytokines and growth factors that act as mitogens for melanogenesis . The preceding laser also alters the skin barrier, which results in increased penetration of topical drugs and ultraviolet (UV) radiation.
308 nm excimer laser is a monochromatic, target type treatment and allows the delivery of higher fluences to the lesions and avoids damage to the surrounding normal skin resulting in a faster and more effective pigmentation with minimal side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo, Excimer Laser, Fractional CO2 Laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
no masking
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vitiligo patients
Arm Type
Experimental
Arm Description
Thirty Patients complaining of generalized non segmental vitiligo will be recruited in this study. They will be chosen from the attendants of the out-patient clinics of Dermatology, Assiut university hospital. six patches will be selected in each patient.
Intervention Type
Drug
Intervention Name(s)
Topical travoprost 0.004% solution
Intervention Description
30 Patches treated with Topical Travoprost 0.004% solution: Topical travoprost 0.004% solution once daily (1 drop for each 2.5 x 2.5 cm2) for 3 months.
Intervention Type
Device
Intervention Name(s)
Fractional CO2 laser
Intervention Description
30 Patches treated with Fractional CO2 laser: Fractional CO2 laser sessions twice monthly for 3 months, parameters settings as follows: Energy\ dot 100mj, pulse duration 5ms, density level 17, pattern: array, depth level 1, 2 passes used
Intervention Type
Device
Intervention Name(s)
Excimer laser
Intervention Description
30 Patches treated with Excimer laser: Excimer laser sessions will be repeated twice weekly on the selected patch only, The starting dose will be 200 mj /cm2, an increase of 100 mJ/cm2 in the following session if no erythema appears, an increase of 50 mJ/cm2 every session till the appearance of erythema that lasts 24 hours or more.
Intervention Type
Other
Intervention Name(s)
Combination therapy
Intervention Description
30 Patches treated with Combination therapy: Fractional CO2 laser twice per month followed by application of topical travoprost 0,004% daily and excimer laser twice weekly .
Intervention Type
Other
Intervention Name(s)
Excimer laser and travoprost
Intervention Description
30 Patches treated with Excimer laser twice weekly and topical travoprost once daily for 3 months
Intervention Type
Other
Intervention Name(s)
fractional CO2 laser and topical travoprost
Intervention Description
30 Patches treated with fractional CO2 laser twice monthly and topical travoprost once daily for 3 months
Primary Outcome Measure Information:
Title
clinical improvement through VASI score
Description
VASI score will be calculated for each patient at start, every 4 weeks and 6 months after the last session.
VASI = ∑ all treated sites [number of hand units] X [% residual depigmentation].
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Patients satisfaction
Description
according to the following scale:
dissatisfied
neutral
somewhat satisfied
moderately satisfied
very satisfied
Time Frame
9 months
Title
percent of repigmentation
Description
The percent of repigmentation will be calculated every 4 weeks of treatment and 6 months after the last session by a scoring system .
< 25% repigmentation (poor response). 25-50% repigmentation (fair response). 50-75% repigmentation (good response). > 75% repigmentation (excellent response).
Time Frame
9 months
Title
Histopathological evaluation
Description
Skin biopsy will be taken from the treated lesions after treatment, Hematoxylin and eosin-stained slides will be examined microscopically to evaluate the epidermal and dermal pathological changes: (1) evaluation of dermal perivascular inflammatory infiltrate density; (2) signs of pigmentation in the form of residual melanin in epidermis or dermal melanophages .
Time Frame
9 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 older than 12 years.
Patients with generalized non-segmental vitiligo.
No previous treatment for vitiligo in the last 1 month.
Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.
Exclusion Criteria:
Patients with sensitivity to travoprost.
Patients with photosensitivity.
Patients with history or active skin cancer.
No other dermatological or systemic diseases.
Active infections .
Pregnant or lactating females.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hatem Zidan, Prof.DR
Phone
01003420217
Email
hzma03@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmin Tawfik, DR
12. IPD Sharing Statement
Citations:
PubMed Identifier
27538097
Citation
Fa Y, Lin Y, Chi XJ, Shi WH, Wang JL, Guo X, Geng JH, Liu HX, Zhang FR. Treatment of vitiligo with 308-nm excimer laser: our experience from a 2-year follow-up of 979 Chinese patients. J Eur Acad Dermatol Venereol. 2017 Feb;31(2):337-340. doi: 10.1111/jdv.13917. Epub 2016 Sep 19.
Results Reference
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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
31541597
Citation
Khattab FM, Abdelbary E, Fawzi M. Evaluation of combined excimer laser and platelet-rich plasma for the treatment of nonsegmental vitiligo: A prospective comparative study. J Cosmet Dermatol. 2020 Apr;19(4):869-877. doi: 10.1111/jocd.13103. Epub 2019 Sep 21.
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
PubMed Identifier
29707867
Citation
Doghaim NN, Gheida SF, El-Tatawy RA, Mohammed Ali DA. Combination of fractional carbon dioxide laser with narrow band ultraviolet B to induce repigmentation in stable vitiligo: A comparative study. J Cosmet Dermatol. 2019 Feb;18(1):142-149. doi: 10.1111/jocd.12553. Epub 2018 Apr 30.
Results Reference
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Effect Of Topical Prostaglandin F2α Analogs,Fractional CO2 Laser, Excimer Laser Or Their Combination In Treatment Of Vitiligo
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