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

NCT01354717 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2014-10-20

No results posted yet for this study

Summary

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.

Conditions

  • Actinic Keratoses

Interventions

DRUG

Brand Carac

treatment of actinic keratosis

DRUG

Generic 0.5% 5-fluorouracil cream

treatment of actinic keratosis

OTHER

Placebo cream

treatment of actinic keratosis

Sponsors & Collaborators

  • Spear Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Melanie Appell, M.D. · Alliance Clinical Research, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-03-31
Completion
2011-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01354717 on ClinicalTrials.gov