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Cryosurgery and Cream Combination for Actinic Keratosis

NCT03037541 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-08-29

Study results available
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Summary

Carac 0.5% cream is approved for daily topical treatment of AK's for up to four weeks as tolerated, though local irritation often occurs within the first week of treatment and increases in a dose-dependent manner. In this study, the investigators will examine the combination of standard cryosurgery treatment followed by a shortened course of topical fluorouracil cram. The investigators anticipate that a one week treatment course will maintain overall effectiveness when combined with previous cryosurgery, but will reduce the overall adverse effects of topical therapy due to the reduced treatment time and the presence of fewer baseline lesions to treat. This treatment approach may provide a more acceptable risk/benefit ratio option for patients with more extensive disease and simplify standard combination treatment options. The primary objective is to evaluate the efficacy of combination cryosurgery and 5-fluorouracil0.5% cream, compared to combination cryosurgery and placebo in the treatment of actinic keratosis lesions. The efficacy of this combination therapy will be evaluated by assessing AK lesion clearance. The primary efficacy parameter will be 10% clearance of all AK lesions from treatment initiation to end-of-treatment.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Carac Cream

Carac Cream will be used once daily for seven consecutive days

DRUG

Placebo Cetaphil cream

Placebo Cetaphil Cream will be used once daily for seven consecutive days

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Joseph Jorizzo, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-05
Primary Completion
2013-10-29
Completion
2013-10-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03037541 on ClinicalTrials.gov