Vitiligo - Macular DepigmentationPhase 2NCT07016113
0.005% Latanoprost Gel for Nonsegmental Vitiligo
A Phase 2 study testing 0.005% latanoprost gel and 0.1% mometasone furoate cream in people with Vitiligo - Macular Depigmentation, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Vitiligo - Macular Depigmentation
- What is being tested?
- 0.005% latanoprost gel and 0.1% mometasone furoate cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2025to 30 Nov 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the 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
- Being tested
- 0.005% latanoprost gel, 0.1% mometasone furoate cream
- Keywords
- Latanoprost, Vitiligo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.005% latanoprost gelDrug
- 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 creamDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 0.1% mometasone furoate cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (2)
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.
Measured: From enrollment to the end of treatment at 12 weeks
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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vitiligo - Macular DepigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: 0.005% latanoprost gel and 308 nm excimer phototherapy Group B: 0.1% mometasone furoate cream and 308 nm excimer phototherapy
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reiva F Dwiyana, MD, PhD, Principal investigator, Hasan Sadikin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016113
- Sponsor's protocol ID
- DV-202506.01
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19627411Korobko 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.
PubMed 27329330Anbar 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.
PubMed 25545321Nowroozpoor 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.
PubMed 31758835
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07016113
- Acronym / sponsor ID
- DV-202506.01
- Conditions
- Vitiligo - Macular Depigmentation
- Keywords
- Latanoprost, Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Group A: 0.005% latanoprost gel and 308 nm excimer phototherapy Group B: 0.1% mometasone furoate cream and 308 nm excimer phototherapy
| Arm | Type | Receives |
|---|---|---|
| Group A: 0.005% latanoprost gel and 308 nm excimer phototherapy | Experimental | 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. |
| Group B : 0.1% mometasone furoate cream and 308 nm excimer phototherapy | Active comparator | 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Group A: 0.005% latanoprost gel and 308 nm excimer phototherapy |
| 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. | Drug | Group B : 0.1% mometasone furoate cream and 308 nm excimer phototherapy |
Primary outcome
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.
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.
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.
2 secondary outcomes
VASI score assessment
Time frame: From enrollment to the end of treatment at 12 weeks
Side effects and subjective complaints
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Results publication: PubMed 19627411Anbar 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.
- Results publication: PubMed 27329330Korobko 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.
- Results publication: PubMed 25545321Anbar 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.
- Results publication: PubMed 31758835Nowroozpoor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reiva F Dwiyana, MD, PhD principal investigator
Hasan Sadikin General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.005% latanoprost gel and 0.1% mometasone furoate cream in people with Vitiligo - Macular Depigmentation, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Safira M Pranata, MD (+6281220648003, safira14001@mail.unpad.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area of repigmentation (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07016113, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.