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Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Oct 30, 2024 to Dec 30, 2025v8
  2. Primary and study completion dates: Apr 30, 2024 to Oct 30, 2024v7
  3. Primary and study completion dates: Dec 30, 2023 to Apr 30, 2024v6
  4. Primary and study completion dates: Nov 15, 2023 to Dec 30, 2023v5
  5. Primary and study completion dates: Mar 15, 2023 to Nov 15, 2023v4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  2. Start date: Sep 15, 2022 to Oct 15, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05536856
Lead Sponsor Al-Azhar University
Conditions
(from sponsor)		 Vitiligo, Topical Fluorouracil, Effervescent Mixture
Related terms Vitiligo
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov