0.005% Latanoprost Gel for Nonsegmental Vitiligo

Официальное название

Comparison of the Effectiveness Between a Combination of 0.005% Latanoprost Gel With 308 nm Excimer Phototherapy and a Combination of 0.1% Mometasone Furoate Cream With 308 nm Excimer Phototherapy on Repigmentation of Nonsegmental Vitiligo in Children

Обзор

Latanoprost, a prostaglandin F2α (PGF2α) analog used for glaucoma treatment, is known to cause iris darkening, hypertrichosis, and periocular skin hyperpigmentation. PGF2α has been shown to stimulate the growth of melanocyte dendrites, increasing dendricity even at low doses, as well as enhancing tyrosinase activity and quantity, thereby promoting repigmentation. Studies on the use of 0.005% latanoprost gel in both children and adults with vitiligo have demonstrated effective repigmentation without reported side effects.

Подробное описание

Vitiligo is an acquired pigmentation disorder caused by the progressive loss of melanocytes in the epidermal layer of the skin and/or mucosa, characterized by macules or patches of depigmentation. Vitiligo can occur at any age, including in childhood. Treatment options for vitiligo include medical therapies (topical, systemic, and radiation) as well as surgical approaches. A combination of topical corticosteroids and phototherapy has shown fairly good repigmentation success in treating vitiligo in children. However, long-term use can lead to side effects such as skin atrophy, striae, telangiectasia, hypopigmentation, acneiform eruptions, and hypertrichosis. Latanoprost, a prostaglandin F2α (PGF2α) analog used for glaucoma treatment, is known to cause iris darkening, hypertrichosis, and periocular skin hyperpigmentation. Because of these effects, it has been studied as a treatment for alopecia and hypopigmentation disorders. PGF2α has been shown to stimulate the growth of melanocyte dendrites, increasing dendricity even at low doses, as well as enhancing tyrosinase activity and quantity, thereby promoting repigmentation. Studies on the use of 0.005% latanoprost gel in both children and adults with vitiligo have demonstrated effective repigmentation without reported side effects. To date, there have been no published studies in Indonesia investigating the use of 0.005% topical latanoprost gel for the repigmentation of stable vitiligo lesions in children. Therefore, research comparing the effectiveness of latanoprost gel and 0.1% mometasone furoate cream in combination with phototherapy-the mainstay treatment for pediatric vitiligo in Indonesia-is necessary.

Вмешательства

• Препарат 0.005% latanoprost gel
  \- Apply 0.005% latanoprost gel to the predetermined skin lesions twice daily (morning and evening) every day for 12 weeks. - Phototherapy is administered at a dose based on the lesion's location and the response to previous phototherapy sessions. Phototherapy is performed twice a week for 12 weeks.
• Препарат 0.1% mometasone furoate cream
  \- Apply 0.1% mometasone furoate cream to the predetermined skin lesions twice daily (morning and evening) for 12 weeks. - Phototherapy is administered at a dose based on the lesion's location and the response to previous phototherapy sessions. Phototherapy is performed twice a week for 12 weeks.

Первичные конечные точки

• Area of repigmentation [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Pattern of repigmentation [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Number of lesions with repigmentation [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (2)

• VASI score assessment [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Side effects and subjective complaints [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

• Patients with non-segmental vitiligo.
• Patients with stable vitiligo for at least 6 months based on the Vitiligo Disease Activity (VIDA) score.
• Aged 10-17 years.
• Affected area <10%.
• Having at least two lesions to be treated. The vitiligo lesions selected for treatment must meet the following criteria:

• Relatively the same size, ranging from a minimum of 1 cm² to 4 cm².
• Bilateral location on both sides of the body.
• A minimum distance of 5 cm between the studied lesions and other vitiligo lesions.
• Not located on the palms, soles, or genital area.

Критерии исключения

• Use of topical therapy (corticosteroids, calcineurin inhibitors, psoralen, and antioxidants) for at least 2 weeks before the study, systemic therapy (corticosteroids, antioxidants, and vitamin D) for at least 4 weeks before the study, and phototherapy for at least 4 weeks before the study.
• Presence of other active autoimmune diseases such as type 1 diabetes mellitus, thyroid disease, alopecia areata, rheumatoid arthritis, or Addison's disease, based on medical history and physical examination.
• History of or current skin cancer, photosensitivity, or undergoing radiotherapy.
• Allergy or contraindication to topical corticosteroids or latanoprost.
• History of hypertension, asthma, diabetes mellitus, anemia, kidney, liver, neurological, or cardiovascular diseases.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Hasan Sadikin General Hospital — Bandung

Публикации

• Anbar TS, El-Ammawi TS, Barakat M, Fawzy A. Skin pigmentation after NB-UVB and three analogues of prostaglandin F(2alpha) in guinea pigs: a comparative study. J Eur Acad Dermatol Venereol. 2010 Jan;24(1):28-31. doi: 10.1111/j.1468-3083.2009.03346.x. Epub 2009 Jul 13. PMID 19627411
• Korobko IV, Lomonosov KM. A pilot comparative study of topical latanoprost and tacrolimus in combination with narrow-band ultraviolet B phototherapy and microneedling for the treatment of nonsegmental vitiligo. Dermatol Ther. 2016 Nov;29(6):437-441. doi: 10.1111/dth.12383. Epub 2016 Jun 21. PMID 27329330
• Anbar TS, El-Ammawi TS, Abdel-Rahman AT, Hanna MR. The effect of latanoprost on vitiligo: a preliminary comparative study. Int J Dermatol. 2015;54(5):587-93. doi: 10.1111/ijd.12631. Epub 2014 Dec 29. PMID 25545321
• Nowroozpoor Dailami K, Hosseini A, Rahmatpour Rokni G, Saeedi M, Morteza-Semnani K, Sadeghi Z, Ghasemzadeh Diva SM, Goldust M, Lotti T, Vojvodic A, Goren A, Sonthalia S, Rathod D. Efficacy of topical latanoprost in the treatment of eyelid vitiligo: A randomized, double-blind clinical trial study. Dermatol Ther. 2020 Jan;33(1):e13175. doi: 10.1111/dth.13175. Epub 2019 Dec 26. PMID 31758835

Идентификаторы

NCT: NCT07016113 · DV-202506.01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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