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Not yet recruiting NCT07016113

0.005% Latanoprost Gel for Nonsegmental Vitiligo

Phase II Interventional Vitiligo - Macular Depigmentation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 0.005% latanoprost gel, 0.1% mometasone furoate cream.
Who it may be relevant to
Registry conditions: Vitiligo - Macular Depigmentation. Basic parameters: 10 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug 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.
  • Drug 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.

Primary outcome measures

  • Area of repigmentation [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Pattern of repigmentation [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Number of lesions with repigmentation [Time frame: From enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (2)
  • VASI score assessment [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Side effects and subjective complaints [Time frame: From enrollment to the end of treatment at 12 weeks]

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:
  • 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Hasan Sadikin General Hospital — Bandung

Publications

  • 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

Identifiers

NCT: NCT07016113 · DV-202506.01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗