VitiligoNCT06209138
5-fluorouracil for Treatment of Stable Vitiligo
A study testing 5 fluorouracil and Saline in people with Vitiligo, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Vitiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- 5 fluorouracil and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jan 2024to 15 Apr 2024
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with stable vitlligo
Who cannot join
- patients under the age of 10 years.
- Individuals with a history of the Koebner phenomenon, a tendency for keloid or hypertrophic scarring
- Pregnancy.
- Recent isotretinoin therapy within the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailoring of HPMC-Zein Based Film Forming Gel of 5-fluorouracil for Treat-ment of Stable Vitiligo: a Strategy Assisted by Carbon Dioxide Laser Dermabra-sion
Vitiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal.
Read the detailed description
Vtiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal. 5FU is a well-known chemotherapeutic agent that has been used for colorectal cancer treatment. The drug prevents DNA synthesis by inhibiting the thymidylate synthetase. The hyperpigmenta-tion of the skin is the most side effect observed with 5-FU therapy which directed its use in treat-ment of vitiligo. Besides, many studies reported that 5-FU could induce regimentation in vitiligo by direct stimulation of melanocytes and increasing melanosomes numbers in the keratinocytes.
- Conditions
- Vitiligo
- Being tested
- 5 fluorouracil, Saline
- Keywords
- 5FU, Film forming gel, vitiligo, JAK3 gene expression, Dermabrasion
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 fluorouracilDrug
5 fluorouracil (5FU) using different ratios of hydroxyl propyl methyl cellulose (HPMC) and Zein
SalineOther
Normal saline solution contains 0.9 percent sodium chloride (salt)
| Study group | Role | What they receive |
|---|---|---|
| CO2 laser assisted dermabrasion and 5FU film | Experimental | Not described Receives: Drug: 5 fluorouracil |
| CO2 laser assisted dermabrasion and saline | Active comparator | Not described Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guartile grading scale
A grading system with a quartile grading scale was used. Here, grading of > 75% will be considered excellent improvement, very good (51-75%), good (50-25%), poor (<25%), mild (25%), and poor improvement if less than 25% grading.
Measured: 2 months
analysis of Jak3 expression in vitiligo lesions
the improvement will be associated with a reduction in JAK levels
Measured: 2months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start23 Jan 2024
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud A Makki, MD, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209138
- Sponsor's protocol ID
- HV04/2020
- Status last verified
- Apr 2024
- First submitted
- 22 Dec 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring of HPMC-Zein Based Film Forming Gel of 5-fluorouracil for Treat-ment of Stable Vitiligo: a Strategy Assisted by Carbon Dioxide Laser Dermabra-sion
- ClinicalTrials.gov ID
- NCT06209138
- Acronym / sponsor ID
- HV04/2020
- Conditions
- Vitiligo
- Keywords
- 5FU, Film forming gel, vitiligo, JAK3 gene expression, Dermabrasion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 17 Jan 2024 (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.
Vitiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal.
Detailed description
Vtiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal. 5FU is a well-known chemotherapeutic agent that has been used for colorectal cancer treatment. The drug prevents DNA synthesis by inhibiting the thymidylate synthetase. The hyperpigmenta-tion of the skin is the most side effect observed with 5-FU therapy which directed its use in treat-ment of vitiligo. Besides, many studies reported that 5-FU could induce regimentation in vitiligo by direct stimulation of melanocytes and increasing melanosomes numbers in the keratinocytes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 laser assisted dermabrasion and 5FU film | Experimental | Drug: 5 fluorouracil |
| CO2 laser assisted dermabrasion and saline | Active comparator | Other: Saline |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with stable vitlligo
Key exclusion criteria (4 listed)
- patients under the age of 10 years.
- Individuals with a history of the Koebner phenomenon, a tendency for keloid or hypertrophic scarring
- Pregnancy.
- Recent isotretinoin therapy within the last 6 months.
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 |
|---|---|---|
| 5 fluorouracil5 fluorouracil (5FU) using different ratios of hydroxyl propyl methyl cellulose (HPMC) and Zein | Drug | CO2 laser assisted dermabrasion and 5FU film |
| SalineNormal saline solution contains 0.9 percent sodium chloride (salt) | Other | CO2 laser assisted dermabrasion and saline |
Primary outcome
Guartile grading scale
Time frame: 2 months
A grading system with a quartile grading scale was used. Here, grading of > 75% will be considered excellent improvement, very good (51-75%), good (50-25%), poor (<25%), mild (25%), and poor improvement if less than 25% grading.
analysis of Jak3 expression in vitiligo lesions
Time frame: 2months
the improvement will be associated with a reduction in JAK levels
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 17 Apr 2024.
- 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 5 fluorouracil and Saline in people with Vitiligo, run by Al-Azhar 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 4 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 17 Apr 2024. 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. 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?
Guartile grading scale (time frame: 2 months). The study lists 2 primary outcomes in all. 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 17 Apr 2024.