Bimatoprost 0.03% Solution With NB-UVB Versus Their Use With Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo

Generalized Vitiligo Clinical Trial

Official title:

Bimatoprost 0.03% Solution, NB-UVB and Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03487042
• Other study ID #: BSNUFCO2
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 11, 2018
• Last updated: March 27, 2018
• Start date: May 2018
• Est. completion date: December 2019

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: Amira Abdel-Motaleb
• Phone: 01005263721
• Email: Amiraali21[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Patients older than 12.

2. Patients with non-segmental vitiligo.

3. Lesions stable for at least one year.

4. Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.

5. No sex or site predilection.

6. Bilateral and symmetrical lesions with maximum size of 10×10 cm.

Exclusion Criteria:

1. Patients with active infection.

2. Patients with sensitivity to bimatoprost or photosensitivity.

3. Patients with history or active skin cancer.

4. Pregnant or lactating females.

Related Conditions & MeSH terms

• Generalized Vitiligo
• Vitiligo

Intervention

Drug:
• Bimatoprost 0.03% ophthalmic solution
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (9)

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. 2017 Aug 20. doi: 10.1111/jocd.12397. [Epub ahead of print] — View 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):473-91. doi: 10.1016/j.jaad.2010.11.061. Review. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 months
Primary	Frequency and types of side effects	Frequency and types of side effects.	3 months
Secondary	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.	3 months
Secondary	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	6 months