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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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ClinicalTrials.gov Identifier: NCT03487042
Recruitment Status : Not yet recruiting
First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Aml Hassan Ali, Assiut University

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.


Condition or disease Intervention/treatment Phase
Generalized Vitiligo Drug: Bimatoprost 0.03% ophthalmic solution Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bimatoprost 0.03% Solution, NB-UVB and Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: Generalized vitiligo patients

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

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.

Other Names:
  • Narrow band ultraviolet rays B
  • Fractional carbon dioxide laser




Primary Outcome Measures :
  1. Repigmentation of skin lesions [ Time Frame: 3 months ]

    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).

  2. Frequency and types of side effects [ Time Frame: 3 months ]
    Frequency and types of side effects.


Secondary Outcome Measures :
  1. Vitiligo area scoring index score [ Time Frame: 3 months ]
    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.

  2. Patient satisfaction [ Time Frame: 6 months ]

    The patient overall satisfaction will be assessed after 6 months according to Wong Overall satisfaction:

    1. dissatisfied
    2. neutral
    3. somewhat satisfied
    4. moderately satisfied
    5. very satisfied



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487042


Contacts
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Contact: Amira Abdel-Motaleb 01005263721 Amiraali21@yahoo.com
Contact: Yasmin Tawfik 01006033331

Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: Aml Hassan Ali, Principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03487042     History of Changes
Other Study ID Numbers: BSNUFCO2
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Bimatoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents