0.005% Latanoprost Gel for Nonsegmental Vitiligo

NCT07016113 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: DV-202506.01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitiligo - Macular Depigmentation

Keywords

Latanoprost; Vitiligo

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• VASI score assessment

  From enrollment to the end of treatment at 12 weeks

• Side effects and subjective complaints

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

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

EXPERIMENTAL

* 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: 0.005% latanoprost gel

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

ACTIVE COMPARATOR

* 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.

Drug: 0.1% mometasone furoate cream

Interventions

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.

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

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.

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

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location

Related Publications (4)

• 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 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.

  PMID: 27329330 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.

  PMID: 25545321 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.

  PMID: 31758835 RESULT

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Reiva F Dwiyana, MD, PhD

  Hasan Sadikin General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Safira M Pranata, MD

CONTACT

+6281220648003; safira14001@mail.unpad.ac.id

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A: 0.005% latanoprost gel and 308 nm excimer phototherapy Group B: 0.1% mometasone furoate cream and 308 nm excimer phototherapy

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: July 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 30, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

ID (1)