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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

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy End Point
Superiority to Placebo
Therapeutic equivalence with Reference product
Secondary study objectives
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

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
~131 spots leftby Sep 2025
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