Vitiligo VulgarisPTX-5FU-VITNCT07775105
Comparative Study of Topical Pentoxifylline Versus Topical 5-Fluorouracil Combined With Microneedling and NB-UVB for Stable Vitiligo
A study testing Microneedling + topical treatment (PTX 20 mg/ml) followed by NB phototherapy, Microneedling + topical treatment (5-FU 5%) followed by NB phototherapy and Microneedling alone followed by NB phototherapy in people with Vitiligo Vulgaris and Microneedling-Assisted Delivery, run by Tanta University at 1 site in Egypt.
Trial summary
This randomized, single-blinded clinical trial evaluates the efficacy and safety of topical pentoxifylline compared with topical 5-fluorouracil, both combined with microneedling and narrow-band ultraviolet B (NB-UVB) phototherapy, in patients with stable vitiligo. Read more about this study
- Who is it for?
- Ages 6 to 55 years
- Conditions the study is for
- Vitiligo Vulgaris, Microneedling-Assisted Delivery, Phototherapy
- What is being tested?
- Microneedling + topical treatment (PTX 20 mg/ml) followed by NB phototherapy, Microneedling + topical treatment (5-FU 5%) followed by NB phototherapy and Microneedling alone followed by NB phototherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with stable vitiligo. No new or progressive vitiligo lesions for at least 1 year. No vitiligo treatment for at least 3 months. Age 6-55 years based on the enrolled study population
Who cannot join
- History of keloidal tendency. Bleeding tendency. Current anticoagulant therapy. Pregnancy or breastfeeding. Presence of other systemic or dermatological diseases. Contraindications to phototherapy. Photosensitive disorders, including lupus erythematosus or xeroderma pigmentosum.
- Personal or family history of skin cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Topical Pentoxiphylline Versus Topical 5- Fluorouracil Both in Combination With Narrow- Band Ultraviolet B Phototherapy and Microneedling for the Treatment of Vitiligo
This randomized, single-blinded clinical trial evaluates the efficacy and safety of topical pentoxifylline compared with topical 5-fluorouracil, both combined with microneedling and narrow-band ultraviolet B (NB-UVB) phototherapy, in patients with stable vitiligo. A total of 42 patients with stable vitiligo received six biweekly microneedling sessions over three months, with concomitant NB-UVB phototherapy twice weekly, followed by a three-month follow-up period. Each patient had three vitiliginous patches allocated to topical pentoxifylline with microneedling, topical 5-fluorouracil with microneedling, or microneedling alone.
Read the detailed description
Vitiligo is a chronic depigmenting disorder characterized by depigmented macules and patches resulting from selective destruction of melanocytes. Narrow-band ultraviolet B (NB-UVB) phototherapy is an established treatment for vitiligo, while microneedling may enhance treatment response by creating microchannels that improve topical drug delivery and stimulate a wound-healing response.
This study was designed as a single-blinded comparative randomized trial involving 42 patients with stable vitiligo. Eligible patients had stable disease, defined as no new or progressive lesions for one year, and had received no treatment for at least three months. Patients with a history of keloidal or bleeding tendencies, anticoagulant therapy, pregnancy or breastfeeding, systemic or dermatological diseases, contraindications to phototherapy, photosensitive disorders, or a personal or family history of skin cancer were excluded.
In each patient, three vitiliginous patches were randomly assigned to three treatment groups. Group A received microneedling combined with topical pentoxifylline (20 mg/mL), Group B received microneedling combined with topical 5-fluorouracil (5%), and Group C received microneedling alone. Microneedling was performed every two weeks for six sessions. All groups additionally received NB-UVB phototherapy twice weekly for three months, followed by NB-UVB phototherapy alone during the subsequent three-month follow-up period.
Treatment response was assessed at baseline, at the end of treatment, and at three-month follow-up. Three blinded physicians evaluated repigmentation using the Physician Global Aesthetic Improvement Scale (GAIS). Quantitative assessment was also performed using a Visual Analog Scale (VAS) to measure percentage reduction in lesion size. Patient satisfaction and treatment-related adverse effects, including erythema, perilesional hyperpigmentation, and pain, were recorded. Participants were followed for an additional three months to assess durability of repigmentation, recurrence, and worsening of lesions.
The study found that both topical pentoxifylline and topical 5-fluorouracil, when combined with microneedling and NB-UVB, produced greater improvement than microneedling alone. Pentoxifylline showed favorable response rates, particularly for lesions on the trunk, head, and neck, and was associated with fewer adverse effects. Perilesional hyperpigmentation was more frequent with topical 5-fluorouracil.
The study was approved by the Ethics Committee under approval code 35642/8/22, and written informed consent was obtained from all participants after explanation of the study procedures, risks, and objectives.
- Being tested
- Microneedling + topical treatment (PTX 20 mg/ml) followed by NB phototherapy, Microneedling + topical treatment (5-FU 5%) followed by NB phototherapy, Microneedling alone followed by NB phototherapy
- Keywords
- vitiligo, microneedling, Narrow band phototherapy, 5-flurouracil, Pentoxiphylline
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedling + topical treatment (PTX 20 mg/ml) followed by NB phototherapyCombination product
Microneedling + topical treatment (PTX 20 mg/ml) followed by NB phototherapy
Microneedling + topical treatment (5-FU 5%) followed by NB phototherapyCombination product
Microneedling + topical treatment (5-FU 5%) followed by NB phototherapy
Microneedling alone followed by NB phototherapyProcedure or surgery
Microneedling alone followed by NB phototherapy
| Study group | Role | What they receive |
|---|---|---|
| Microneedling + topical treatment (PTX 20 mg/ml) | Active comparator | Microneedling + topical treatment (PTX 20 mg/ml) followed by phototherapy Receives: Combination Product: Microneedling + topical treatment (PTX 20 mg/ml) followed by NB phototherapy |
| Microneedling + topical treatment (5-FU 5%) | Active comparator | Microneedling + topical treatment (5-FU 5%)+phototherapy Receives: Combination Product: Microneedling + topical treatment (5-FU 5%) followed by NB phototherapy |
| Microneedling alone | Placebo comparator | Microneedling alone+phototherapy Receives: Procedure: Microneedling alone followed by NB phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Global Aesthetic Improvement Scale (GAIS) score
Physician-assessed percentage of repigmentation of treated vitiligo lesions using the GAIS.
Measured: After 6 treatment sessions (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Jan 2023
- Primary completion4 Apr 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitiligo VulgarisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesrin Sabry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775105
- Sponsor's protocol ID
- 35642/8/22
- Acronym
- PTX-5FU-VIT
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Topical Pentoxiphylline Versus Topical 5- Fluorouracil Both in Combination With Narrow- Band Ultraviolet B Phototherapy and Microneedling for the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT07775105
- Acronym / sponsor ID
- PTX-5FU-VIT / 35642/8/22
- Keywords
- vitiligo, microneedling, Narrow band phototherapy, 5-flurouracil, Pentoxiphylline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 20 Aug 2026 (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.
This randomized, single-blinded clinical trial evaluates the efficacy and safety of topical pentoxifylline compared with topical 5-fluorouracil, both combined with microneedling and narrow-band ultraviolet B (NB-UVB) phototherapy, in patients with stable vitiligo. A total of 42 patients with stable vitiligo received six biweekly microneedling sessions over three months, with concomitant NB-UVB phototherapy twice weekly, followed by a three-month follow-up period. Each patient had three vitiliginous patches allocated to topical pentoxifylline with microneedling, topical 5-fluorouracil with microneedling, or microneedling alone.
Detailed description
Vitiligo is a chronic depigmenting disorder characterized by depigmented macules and patches resulting from selective destruction of melanocytes. Narrow-band ultraviolet B (NB-UVB) phototherapy is an established treatment for vitiligo, while microneedling may enhance treatment response by creating microchannels that improve topical drug delivery and stimulate a wound-healing response.
This study was designed as a single-blinded comparative randomized trial involving 42 patients with stable vitiligo. Eligible patients had stable disease, defined as no new or progressive lesions for one year, and had received no treatment for at least three months. Patients with a history of keloidal or bleeding tendencies, anticoagulant therapy, pregnancy or breastfeeding, systemic or dermatological diseases, contraindications to phototherapy, photosensitive disorders, or a personal or family history of skin cancer were excluded.
In each patient, three vitiliginous patches were randomly assigned to three treatment groups. Group A received microneedling combined with topical pentoxifylline (20 mg/mL), Group B received microneedling combined with topical 5-fluorouracil (5%), and Group C received microneedling alone. Microneedling was performed every two weeks for six sessions. All groups additionally received NB-UVB phototherapy twice weekly for three months, followed by NB-UVB phototherapy alone during the subsequent three-month follow-up period.
Treatment response was assessed at baseline, at the end of treatment, and at three-month follow-up. Three blinded physicians evaluated repigmentation using the Physician Global Aesthetic Improvement Scale (GAIS). Quantitative assessment was also performed using a Visual Analog Scale (VAS) to measure percentage reduction in lesion size. Patient satisfaction and treatment-related adverse effects, including erythema, perilesional hyperpigmentation, and pain, were recorded. Participants were followed for an additional three months to assess durability of repigmentation, recurrence, and worsening of lesions.
The study found that both topical pentoxifylline and topical 5-fluorouracil, when combined with microneedling and NB-UVB, produced greater improvement than microneedling alone. Pentoxifylline showed favorable response rates, particularly for lesions on the trunk, head, and neck, and was associated with fewer adverse effects. Perilesional hyperpigmentation was more frequent with topical 5-fluorouracil.
The study was approved by the Ethics Committee under approval code 35642/8/22, and written informed consent was obtained from all participants after explanation of the study procedures, risks, and objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microneedling + topical treatment (PTX 20 mg/ml) | Active comparator | Combination Product: Microneedling + topical treatment (PTX 20 mg/ml) followed by NB phototherapyMicroneedling + topical treatment (PTX 20 mg/ml) followed by phototherapy |
| Microneedling + topical treatment (5-FU 5%) | Active comparator | Combination Product: Microneedling + topical treatment (5-FU 5%) followed by NB phototherapyMicroneedling + topical treatment (5-FU 5%)+phototherapy |
| Microneedling alone | Placebo comparator | Procedure: Microneedling alone followed by NB phototherapyMicroneedling alone+phototherapy |
Who may qualify
- Ages
- 6 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with stable vitiligo. No new or progressive vitiligo lesions for at least 1 year. No vitiligo treatment for at least 3 months. Age 6-55 years based on the enrolled study population
Key exclusion criteria (2 listed)
- History of keloidal tendency. Bleeding tendency. Current anticoagulant therapy. Pregnancy or breastfeeding. Presence of other systemic or dermatological diseases. Contraindications to phototherapy. Photosensitive disorders, including lupus erythematosus or xeroderma pigmentosum.
- Personal or family history of skin cancer
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 |
|---|---|---|
| Microneedling + topical treatment (PTX 20 mg/ml) followed by NB phototherapyMicroneedling + topical treatment (PTX 20 mg/ml) followed by NB phototherapy | Combination product | Microneedling + topical treatment (PTX 20 mg/ml) |
| Microneedling + topical treatment (5-FU 5%) followed by NB phototherapyMicroneedling + topical treatment (5-FU 5%) followed by NB phototherapy | Combination product | Microneedling + topical treatment (5-FU 5%) |
| Microneedling alone followed by NB phototherapyMicroneedling alone followed by NB phototherapy | Procedure or surgery | Microneedling alone |
Primary outcome
Physician Global Aesthetic Improvement Scale (GAIS) score
Time frame: After 6 treatment sessions (3 months)
Physician-assessed percentage of repigmentation of treated vitiligo lesions using the GAIS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling + topical treatment (PTX 20 mg/ml) followed by NB phototherapy, Microneedling + topical treatment (5-FU 5%) followed by NB phototherapy and Microneedling alone followed by NB phototherapy in people with Vitiligo Vulgaris and Microneedling-Assisted Delivery, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 20 Aug 2026. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Global Aesthetic Improvement Scale (GAIS) score (time frame: After 6 treatment sessions (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.