Bimatoprost 0.03% Solution With NB-UVB Versus Their Use With Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo
Primary Purpose
Generalized Vitiligo
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bimatoprost 0.03% ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Vitiligo
Eligibility Criteria
Inclusion Criteria:
- Patients older than 12.
- Patients with non-segmental vitiligo.
- Lesions stable for at least one year.
- Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.
- No sex or site predilection.
- Bilateral and symmetrical lesions with maximum size of 10×10 cm.
Exclusion Criteria:
- Patients with active infection.
- Patients with sensitivity to bimatoprost or photosensitivity.
- Patients with history or active skin cancer.
- Pregnant or lactating females.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Generalized vitiligo patients
Arm Description
Each patient with generalized vitiligo will be subjected to the following: One side will be treated by narrow band ultraviolet rays sessions twice weekly for 3 months + topical bimatoprost 0.03% ophthalmic solution solution twice daily ( 1 drop for each 2 cm2 ) and the other side will be treated by topical bimatoprost 0.03% ophthalmic solution twice daily ( 1 drop for each 2 cm2 ) + narrow band ultraviolet rays sessions twice weekly for 3 months + 10.600-nm fractional carbon dioxide laser sessions twice monthly for 3 months.
Outcomes
Primary Outcome Measures
Repigmentation of skin lesions
Patients will be followed up by two blind dermatologists after 3 months to detect:
The percent of repigmentation: that will be subjectively rated with a previously reported scoring system:
< 25% repigmentation (poor).
25-50% repigmentation (fair).
50-75% repigmentation (good). -> 75% repigmentation (excellent).
Frequency and types of side effects
Frequency and types of side effects.
Secondary Outcome Measures
Vitiligo area scoring index score
Vitiligo area scoring index score percent change will be calculated by subtracting the pre- procedure vitiligo area scoring index score from the post-procedure vitiligo area scoring index score and dividing by the pre-procedure vitiligo area scoring index score.
Patient satisfaction
The patient overall satisfaction will be assessed after 6 months according to Wong Overall satisfaction:
dissatisfied
neutral
somewhat satisfied
moderately satisfied
very satisfied
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03487042
Brief Title
Bimatoprost 0.03% Solution With NB-UVB Versus Their Use With Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo
Official Title
Bimatoprost 0.03% Solution, NB-UVB and Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 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
5. Study Description
Brief Summary
Vitiligo is a chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes. It affects approximately 0.5%-2% of general population world-wide, without predilection for sex or race.Vitiligo can be classified into segmental or non-segmental. Non-segmental or generalized vitiligo is the most common clinical presentation and often involves the face and acral regions.
Multiple monotherapy modalities are established to treat vitiligo but the response is variable, unsatisfactory, and requiring a prolonged course. This problem is exaggerated by the multifactorial and polygenic nature of the pathomechanism of the disease. These facts pave the way to combination therapy that showed better and safe repigmentation response than monotherapy.
Detailed Description
Bimatoprost 0.03% ophthalmic solution is a synthetic prostaglandin F2 alpha analog that is approved for the treatment of glaucoma and eyelashes hypotrichosis (Lee et al, 2017). Cutaneous hyperpigmentation of the treated sites has been reported as a side effect with this agent. Phototherapy (narrow band ultraviolet B (NB-UVB)) of wavelength 308 nm, is considered as a successful method of treatment of vitiligo. The cytotoxic T-cells accountable for the destruction of melanocytes and disappearance of melanin are eliminated by phototherapy through apoptosis (diffuse repigmentation) and UVB does stimulate melanocytic proliferation and their migration to the epidermis from nearby follicular units (follicular repigmentation) and perilesional active melanocytes (marginal repigmentation).
In recent years, fractional carbon dioxide laser has been introduced as an add-on treatment for vitiligo. It represents a new modality for skin resurfacing based on the theory of fractional photothermolysis. The beneficial effect of fractional carbon dioxide laser on vitiligo is the release of cytokines and growth factors that act as mitogens for melanogenesis. It also alters the skin barrier, which results in increased penetration of topical drugs and ultraviolet (UV) radiation, so it can be used in combination therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Vitiligo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Generalized vitiligo patients
Arm Type
Experimental
Arm Description
Each patient with generalized vitiligo will be subjected to the following:
One side will be treated by narrow band ultraviolet rays sessions twice weekly for 3 months + topical bimatoprost 0.03% ophthalmic solution solution twice daily ( 1 drop for each 2 cm2 ) and the other side will be treated by topical bimatoprost 0.03% ophthalmic solution twice daily ( 1 drop for each 2 cm2 ) + narrow band ultraviolet rays sessions twice weekly for 3 months + 10.600-nm fractional carbon dioxide laser sessions twice monthly for 3 months.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.03% ophthalmic solution
Other Intervention Name(s)
Narrow band ultraviolet rays B, Fractional carbon dioxide laser
Intervention Description
Each patient will be subjected to the following:
One side will be treated by narrow band ultraviolet rays B sessions twice weekly for 3 months + topical bimatoprost 0.03% solution twice daily ( 1 drop for each 2 cm2 ) and the other side will be treated by topical bimatoprost 0.03% twice daily ( 1 drop for each 2 cm2 ) + narrow band ultraviolet rays B sessions twice weekly for 3 months + 10.600-nm fractional carbon dioxide laser sessions twice monthly for 3 months.
Patients' Evaluation:
The recruited patients will be subjected to:
A) Full history taking. B) General clinical examination. C) Dermatological examination of the skin lesions. D) Vitiligo area scoring index score will be calculated for each patient E) Clinical photographs will be taken at baseline, after each month during treatment and after the end of treatment by 3 months.
F) A skin biopsy from the treated lesions for histochemical examination. F) Dermoscopic evaluation of the treated sites every 2 weeks.
Primary Outcome Measure Information:
Title
Repigmentation of skin lesions
Description
Patients will be followed up by two blind dermatologists after 3 months to detect:
The percent of repigmentation: that will be subjectively rated with a previously reported scoring system:
< 25% repigmentation (poor).
25-50% repigmentation (fair).
50-75% repigmentation (good). -> 75% repigmentation (excellent).
Time Frame
3 months
Title
Frequency and types of side effects
Description
Frequency and types of side effects.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Vitiligo area scoring index score
Description
Vitiligo area scoring index score percent change will be calculated by subtracting the pre- procedure vitiligo area scoring index score from the post-procedure vitiligo area scoring index score and dividing by the pre-procedure vitiligo area scoring index score.
Time Frame
3 months
Title
Patient satisfaction
Description
The patient overall satisfaction will be assessed after 6 months according to Wong Overall satisfaction:
dissatisfied
neutral
somewhat satisfied
moderately satisfied
very satisfied
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than 12.
Patients with non-segmental vitiligo.
Lesions stable for at least one year.
Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.
No sex or site predilection.
Bilateral and symmetrical lesions with maximum size of 10×10 cm.
Exclusion Criteria:
Patients with active infection.
Patients with sensitivity to bimatoprost or photosensitivity.
Patients with history or active skin cancer.
Pregnant or lactating females.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amira Abdel-Motaleb
Phone
01005263721
Email
Amiraali21@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmin Tawfik
Phone
01006033331
12. IPD Sharing Statement
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
background
PubMed Identifier
21839315
Citation
Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.
Results Reference
background
PubMed Identifier
28834191
Citation
Abdelghani R, Ahmed NA, Darwish HM. Combined treatment with fractional carbon dioxide laser, autologous platelet-rich plasma, and narrow band ultraviolet B for vitiligo in different body sites: A prospective, randomized comparative trial. J Cosmet Dermatol. 2018 Jun;17(3):365-372. doi: 10.1111/jocd.12397. Epub 2017 Aug 20.
Results Reference
background
PubMed Identifier
28744094
Citation
Lee D, Mantravadi AV, Myers JS. Patient considerations in ocular hypertension: role of bimatoprost ophthalmic solution. Clin Ophthalmol. 2017 Jul 10;11:1273-1280. doi: 10.2147/OPTH.S118689. eCollection 2017.
Results Reference
background
PubMed Identifier
27550870
Citation
Bagherani N, Smoller BR. Efficacy of bimatoprost in the treatment of non-facial vitiligo. Dermatol Ther. 2017 Mar;30(2). doi: 10.1111/dth.12409. Epub 2016 Aug 23. No abstract available.
Results Reference
background
PubMed Identifier
29123631
Citation
Salah Eldin MM, Sami NA, Aly DG, Hanafy NS. Comparison Between (311-312 nm) Narrow Band Ultraviolet-B Phototherapy and (308 nm) Monochromatic Excimer Light Phototherapy in Treatment of Vitiligo: A Histopathological Study. J Lasers Med Sci. 2017 Summer;8(3):123-127. doi: 10.15171/jlms.2017.22. Epub 2017 Jun 27.
Results Reference
background
PubMed Identifier
24771971
Citation
Omi T, Numano K. The Role of the CO2 Laser and Fractional CO2 Laser in Dermatology. Laser Ther. 2014 Mar 27;23(1):49-60. doi: 10.5978/islsm.14-RE-01.
Results Reference
background
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
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
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Bimatoprost 0.03% Solution With NB-UVB Versus Their Use With Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo
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