Therapeutic Equivalence of Fluorouracil Cream, 5% Compared With Fluorouracil 5% Topical Cream of MylanPharmaceuticals Inc., U.S.A in the Treatment of Actinic Keratosis
Public ClinicalTrials.gov record NCT05078827. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Multi-center, Three-arm, Parallel-group, Multiple-dose, Placebo Controlled Study to Assess the Therapeutic Equivalence of Fluorouracil Cream USP 5% of Encube Ethicals Pvt. Ltd., India Compared With Fluorouracil 5% Topical Cream of Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. in the Treatment of Actinic Keratosis
Study identification
- NCT ID
- NCT05078827
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Encube Ethicals Pvt. Ltd.
- Industry
- Enrollment
- 458 participants
Conditions and interventions
Conditions
Interventions
- Placebo Product (C): Test vehicle cream for fluorouracil 5% of Encube Ethicals Pvt. Ltd., India Drug
- Reference Product (B): Fluorouracil 5% Topical Cream of Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Drug
- Test Product (A): Fluorouracil Cream, 5% topical cream Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2022
- Primary completion
- Oct 31, 2022
- Completion
- Nov 30, 2022
- Last update posted
- Mar 13, 2023
2022
United States locations
- U.S. sites
- 7
- U.S. states
- 3
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CBCC Global Research Site 005 | Bakersfield | California | 93309 | — |
| CBCC Global Research Site 006 | Cerritos | California | 90703 | — |
| CBCC Global Research Site 004 | Lauderdale Lakes | Florida | 33308 | — |
| CBCC Global Research Site 001 | Miami | Florida | 33015 | — |
| CBCC Global Research Site 002 | Miami | Florida | 33175 | — |
| CBCC Global Research Site 003 | Miramar | Florida | 33027 | — |
| CBCC Global Research Site 007 | Sugarloaf | Pennsylvania | 18249 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05078827, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 13, 2023 · Synced May 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05078827 live on ClinicalTrials.gov.