0.005% Latanoprost Gel for Nonsegmental Vitiligo
ConditionVitiligo - Macular Depigmentation
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10-17
SponsorUniversitas Padjadjaran
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
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.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Group A: 0.005% latanoprost gel and 308 nm excimer phototherapyExperimental treatment 1 intervention
Group B: Group B : 0.1% mometasone furoate cream and 308 nm excimer phototherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 12 weeks2
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.
Time frame
From enrollment to the end of treatment at 12 weeks3
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.
Time frame
From enrollment to the end of treatment at 12 weeksSecondary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 12 weeks2
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.
Time frame
From enrollment to the end of treatment at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov
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