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

NCT03487042 | Unknown Phase 4

• 1 other identifier: BSNUFCO2
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Generalized Vitiligo

Outcome Measures

Primary Outcomes (2)

• 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

• Frequency and types of side effects

  Frequency and types of side effects.

  3 months

Secondary Outcomes (2)

• Vitiligo area scoring index score

  3 months

• Patient satisfaction

  6 months

Study Arms (1)

Generalized vitiligo patients

EXPERIMENTAL

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.

Drug: Bimatoprost 0.03% ophthalmic solution

Interventions

Bimatoprost 0.03% ophthalmic solution DRUG

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.

Also known as: Narrow band ultraviolet rays B, Fractional carbon dioxide laser

Generalized vitiligo patients

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with active infection.
• Patients with sensitivity to bimatoprost or photosensitivity.
• Patients with history or active skin cancer.
• Pregnant or lactating females.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• 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.

  PMID: 25596811 BACKGROUND

• 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.

  PMID: 21839315 BACKGROUND

• 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.

  PMID: 28834191 BACKGROUND

• 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.

  PMID: 28744094 BACKGROUND

• 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.

  PMID: 27550870 BACKGROUND

• 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.

  PMID: 29123631 BACKGROUND

• 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.

  PMID: 24771971 BACKGROUND

• 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.

  PMID: 29110015 BACKGROUND

• 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.

  PMID: 21451378 BACKGROUND

MeSH Terms

Interventions

Bimatoprost; Ophthalmic Solutions

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Central Study Contacts

Amira Abdel-Motaleb

CONTACT

01005263721; Amiraali21@yahoo.com

Yasmin Tawfik

CONTACT

01006033331

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: April 3, 2018
• Study Start: May 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 3, 2018

Record last verified: 2018-03