Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07016113

0.005% Latanoprost Gel for Nonsegmental Vitiligo

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Area of repigmentation

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

  2. Pattern of repigmentation

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

  3. Number of lesions with repigmentation

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

Secondary outcomes

  1. VASI score assessment

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

  2. Side effects and subjective complaints

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Safira M Pranata, MD

CONTACT

[email protected]

+6281220648003

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.