NCT07016113

0.005% Latanoprost Gel for Nonsegmental Vitiligo

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Universitas Padjadjaran · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitiligo - Macular Depigmentation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-10-31
• Completion: 2025-11-30
• First posted: 2025-06-11
• Last updated: 2025-06-11

Locations

1 site across 1 country: Indonesia