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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites.
Study identification
- NCT ID
- NCT05078827
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 458 participants
Conditions and interventions
Conditions
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
- Mar 1, 2022 (Actual)
- Primary completion
- Nov 1, 2022 (Actual)
- Completion
- Dec 1, 2022 (Actual)
- Last update posted
- Mar 14, 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 14, 2023 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05078827 live on ClinicalTrials.gov.