0.005% Latanoprost Gel for Nonsegmental Vitiligo

Universitas Padjadjaran

Status and phase: Not yet enrolling; Phase 2

Conditions: Vitiligo - Macular Depigmentation

Treatments: Drug: 0.1% mometasone furoate cream; Drug: 0.005% latanoprost gel

Study type: Interventional

Funder types: Other

Identifiers

NCT07016113

DV-202506.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

10 participants in 2 patient groups

Group A: 0.005% latanoprost gel and 308 nm excimer phototherapy

Experimental group

Description:

* 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.

Treatment:

Drug: 0.005% latanoprost gel

Group B : 0.1% mometasone furoate cream and 308 nm excimer phototherapy

Active Comparator group

Description:

* 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.

Treatment:

Drug: 0.1% mometasone furoate cream