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Cryosurgery and Cream Combination for Actinic Keratosis
Phase 3 trial testing Carac Cream in Actinic Keratosis in 60 participants. Completed in 29 October 2013.
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 5 January 2011 |
| Primary completion | 29 October 2013 |
| Estimated completion | 29 October 2013 |
| Sites | 1 location across United States |
Wake Forest University Health Sciences
Adults 18 to 90, any sex, with Actinic Keratosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment
| Group | Value | 95% CI |
|---|---|---|
| Group 1 Carac (Fluorouracil) 0.5% Cream | 12 | |
| Group 2 Placebo | 13 |
The secondary endpoint is number of participants that receive 75 % clearance of
| Group | Value | 95% CI |
|---|---|---|
| Group 1 Carac (Fluorouracil) 0.5% Cream | 18 | |
| Group 2 Placebo | 16 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Group 1 Carac (Fluorouraci… | Group 2 Placebo |
|---|---|---|---|
| viral infection | Infections and infestations | — | — |
| basal cell carcinoma | Skin and subcutaneous tissue disorders | — | — |
| joint pain | Musculoskeletal and connective tissue disorders | — | — |
| tooth pain | Infections and infestations | — | — |
Data from ClinicalTrials.gov NCT03037541 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing