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Anti-metabolites

Test Product (A): Fluorouracil Cream, 5% topical cream for Actinic Keratosis

Phase 3

Waitlist Available

Research Sponsored by Encube Ethicals Pvt. Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial found that a 5% strength of fluorouracil was more effective than a lower concentration in treating actinic keratoses.

Eligible Conditions

Actinic Keratosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Efficacy End Point

Superiority to Placebo

Therapeutic equivalence with Reference product

Secondary outcome measures

Safety Analysis

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Arms and InterventionsExperimental Treatment1 Intervention

Test Product (A): Fluorouracil Cream, 5% of Encube Ethicals Pvt. Ltd., India

Group II: Comparator ArmActive Control1 Intervention

Reference Product (B): Fluorouracil 5% Topical Cream of Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

Group III: Placebo ArmPlacebo Group1 Intervention

Placebo Product (C): Test vehicle cream for fluorouracil 5% of Encube Ethicals Pvt. Ltd., India

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Test Product (A): Fluorouracil Cream, 5% topical cream

2022

Completed Phase 3

~460

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Encube Ethicals Pvt. Ltd.Lead Sponsor

3 Previous Clinical Trials

1,740 Total Patients Enrolled

CBCC Global ResearchNETWORK

7 Previous Clinical Trials

825 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the standard protocol for Test Product (A): Fluorouracil Cream, 5% topical cream?

"Fluorouracil Cream, 5% topical cream is used to treat actinic keratosis and other conditions like superficial basal cell carcinoma, rectal carcinoma, and malignant neoplasm of colon."

Answered by AI

In how many different medical clinics is this clinical study being performed today?

"Presently, this trial is being conducted at 7 distinct locations. 4 of these sites are in California (Cerritos, Bakersfield and Miramar) with the remaining 3 spread throughout the country. If you choose to participate in this research study, it would be advantageous to select a location near you so as to reduce travel time and hassle."

Answered by AI

Are there any dangerous side effects associated with using Test Product (A): Fluorouracil Cream, 5% topical cream?

"There is prior clinical data supporting the safety of Test Product (A): Fluorouracil Cream, 5% topical cream, so it received a score of 3."

Answered by AI

Does this new fluorouracil cream have any precedence in other medical trials?

"There are a total of 331 ongoing clinical trials for Test Product (A): Fluorouracil Cream, 5% topical cream. Out of those, 106 are in Phase 3 and 18810 locations worldwide are running trials."

Answered by AI

Are there any available positions for volunteers in this clinical trial?

"That is correct, the online clinicaltrials.gov registry shows that this study is actively looking for patients to enroll. The trial was posted on March 1st, 2022 and was edited April 22nd, 2022. There are 7 sites recruiting a total of 430 patients."

Answered by AI

What is the participation level in this research project?

"In order to run this trial, we need 430 patients that meet the pre-determined eligibility requirements. Two of the locations where people can participate in the trial are CBCC Global Research Site 006 located in Cerritos, California and CBCC Global Research Site 005 situated in Bakersfield, Pennsylvania."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Therapeutic Equivalence of Fluorouracil Cream, 5% Compared With Fluorouracil 5% Topical Cream of MylanPharmaceuticals Inc., U.S.A in the Treatment of Actinic Keratosis

2022. "Therapeutic Equivalence of Fluorouracil Cream, 5% Compared With Fluorouracil 5% Topical Cream of MylanPharmaceuticals Inc., U.S.A in the Treatment of Actinic Keratosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05078827.