Clinical trial NCT07016113: 0.005% Latanoprost Gel for Nonsegmental Vitiligo
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Vitiligo - Macular Depigmentation
Keywords: Latanoprost
Vitiligo
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: 0.005% latanoprost gel and 308 nm excimer phototherapy Group B: 0.1% mometasone furoate cream and 308 nm excimer phototherapy
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Area of repigmentation
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Pattern of repigmentation
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Number of lesions with repigmentation
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: VASI score assessment
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Side effects and subjective complaints
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin General Hospital
state: West Java
Study officials:
affiliation: Hasan Sadikin General Hospital
name: Reiva F Dwiyana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.