NCT05536856 Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo
| NCT ID | NCT05536856 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Al-Azhar University |
| Condition | Vitiligo |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-10-15 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2022-10-15 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A novel approach for 5-Fluorouracil delivery based on a solid effervescent formulation is proposed . 5-Fluorouracil is water soluble (\~50mg/ml) and therefore has been used for the development of novel topical formulations including nano and microparticles intended for skin targeting. After hydration 5-Fluorouracil could form a complex, a suspension or even be formulated to generate effervescence. In effervescent technology, gas bubbles occur from the liquid after chemical reaction between alkali salts and organic acids (mainly citric or tartaric. Due to liberation in CO2 gas, the dissolution of drug in water is enhanced. The aim of this study is the development and clinical evaluation of topical 5-florouracil effervescent powder formulation in the treatment of vitiligo.
Eligibility Criteria
Inclusion Criteria: * Patients who will be diagnosed as localized stable vitiligo. * Age older than 10 years * Stability of lesions for a duration of at least 1 year. * Patients who didn't receive treatment for vitiligo in the previous 6 weeks before starting the study. * Patients who agreed to join the study and signed written consent and continued till the end of the follow up period Exclusion Criteria: * Patients with vitiligo patches on mucous membrane, * Patients with Koebner phenomenon, * Other uncontrolled systemic illnesses * Patients receiving any systemic or topical treatment for vitiligo
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05536856 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 70 Years, studying Vitiligo. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05536856 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05536856 currently recruiting?
Yes, NCT05536856 is actively recruiting participants. Contact the research team at nevenabdo@azhar.edu.eg for enrollment information.
Where is the NCT05536856 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT05536856 clinical trial?
NCT05536856 is sponsored by Al-Azhar University. The trial plans to enroll 60 participants.