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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: 0.005% latanoprost gel and 308 nm excimer phototherapy | Experimental |
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| Group B : 0.1% mometasone furoate cream and 308 nm excimer phototherapy | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.005% latanoprost gel | Drug | - 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area of repigmentation | The percentage level of repigmentation area in lesions before and after therapy. Evaluated by Software ImageJ on the week 2, week 4, week 6, week 8, week 10, week 12. The assessment categories are as follows: Poor for less than 50%, Fair for 50 to 74%, Good for 75 to 89%, and Excellent for 90 to 100%. These percentage ranges help classify the level of achievement or effectiveness in the evaluation. | From enrollment to the end of treatment at 12 weeks |
| Pattern of repigmentation | The pattern of skin color return, such as perifolicular, diffuse, marginal or mixed. Evaluated by dermoscopy on the week 2, week 4, week 6, week 8, week 10, week 12. | From enrollment to the end of treatment at 12 weeks |
| Number of lesions with repigmentation | The initial appearance of repigmentation on VNS lesions after treatment. Evaluated by dermoscopy on the week 2, week 4, week 6, week 8, week 10, week 12. | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| VASI score assessment | An assessment to measure the area of depigmented lesions and the severity of depigmentation. Evaluated by VASI score on the week 2, week 4, week 6, week 8, week 10, week 12. The improvement levels are categorized as follows: Minimal improvement ranges from 0 to +10, Improvement ranges from +10 to 25, Significant improvement ranges from +25 to 50, and Excellent improvement is above +50. These categories help to describe the degree of progress observed. |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Safira M Pranata, MD | Contact | +6281220648003 | safira14001@mail.unpad.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Reiva F Dwiyana, MD, PhD | Hasan Sadikin General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasan Sadikin General Hospital | Bandung | West Java | 40161 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19627411 | Result | 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. | |
| 27329330 | Result | 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. |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Group A: 0.005% latanoprost gel and 308 nm excimer phototherapy Group B: 0.1% mometasone furoate cream and 308 nm excimer phototherapy
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| 0.1% mometasone furoate cream | Drug | - 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. |
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| From enrollment to the end of treatment at 12 weeks |
| Side effects and subjective complaints | Side effects and subjective complaints after the intervention. Evaluated by history taking, on the week 2, week 4, week 6, week 8, week 10, and week 12. | From enrollment to the end of treatment at 12 weeks |
| 25545321 | Result | 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. |
| 31758835 | Result | 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. |