FindMyKOL
Clinical trialNCT01354717CompletedPhase 3Interventional

Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo

SponsorSpear PharmaceuticalsEnrollment377Actinic Keratoses
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a double-blind, randomized, placebo-controlled, three treatment parallel study in which normal, healthy men and women (age 45-85) with actinic keratosis will be treated on the face once daily for two weeks with 5-Fluorouracil Cream 0.5%, Spear Pharmaceuticals (Generic), Carac® Cream 0.5% (Brand), or Cream Vehicle (Placebo). Actinic keratoses will be counted at the baseline visit and at the visit four weeks following cessation of treatment.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

No facility list is in our current data snapshot for this study. The registry record on ClinicalTrials.gov ↗ carries any published locations. Why? →

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Brand CaracGeneric 0.5% 5-fluorouracil cream
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2010
Primary completion
31 Mar 2011
Completion
31 Mar 2011
Last update posted
20 Oct 2014
Registered enrollment
377
Registry id
NCT01354717
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.