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NCT03037541 · ClinicalTrials.gov registry record · Phase 3
Cryosurgery and Cream Combination for Actinic Keratosis
A Phase 3 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
NCT03037541 is a Phase 3 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 60 participants.
The verdict
NCT03037541, a Phase 3 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
Study 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.
Interventions
- DRUG Carac Cream
- DRUG Placebo Cetaphil cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-01-05 |
| Est. Completion | 2013-10-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03037541
The ClinicalTrials.gov registry entry for NCT03037541 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Carac Cream is the first listed.
NCT03037541 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03037541 about?
NCT03037541 is a clinical study titled "Cryosurgery and Cream Combination for Actinic Keratosis". 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 ...
What is the current status of trial NCT03037541?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2011-01-05. Estimated completion is 2013-10-29.
What interventions are being tested in trial NCT03037541?
The interventions under investigation include: Carac Cream (DRUG), Placebo Cetaphil cream (DRUG).
Who is sponsoring clinical trial NCT03037541?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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