A Randomized Trial of the Off-label Use of Imiquimod, 5%, Cream With vs Without Tazarotene, 0.1%, Gel for the Treatment of Lentigo Maligna, Followed by Conservative Staged Excisions

    loading  Checking for direct PDF access through Ovid

Abstract

Objective

To determine if the complete response rates of lentigo maligna (LM) to imiquimod, 5%, cream can be improved by the addition of a topical retinoid.

Design

Prospective randomized study of patients treated with imiquimod alone vs imiquimod plus a topical retinoid, followed by conservative staged excisions.

Setting

Mohs surgical clinic in an academic institution.

Patients

Ninety patients with biopsy-confirmed LM.

Interventions

Ninety patients with 91 LMs were randomized into 2 groups. One group received imiquimod, 5%, cream 5 d/wk for 3 months, while the other group also received tazarotene, 0.1%, gel 2 d/wk for 3 months. Following topical therapy, all patients underwent staged excisions and frozen section analysis with Melan-A immunostaining to confirm negative margins.

Main Outcome Measure

The presence or absence of residual LM at the time of staged excision.

Results

Forty-six patients with 47 LMs were randomized to receive monotherapy: 42 of 47 LMs reached the intended treatment duration, with 27 complete responses (64%). Forty-four patients with 44 LMs were randomized to receive combined therapy: 37 of 44 LMs reached the intended treatment duration, with 29 complete responses (78%). This difference did not reach statistical significance (P = .17). There have been no recurrences to date, with a mean follow-up period of 42 months.

Conclusions

Among patients who received topical imiquimod with vs without tazarotene, 22% (8 of 37) of lesions vs 36% (15 of 42) of lesions showed residual LM on staged excisions. Pretreating LM with imiquimod, 5%, cream may decrease surgical defect sizes; however, total reliance on topical imiquimod as an alternative to surgery may put the patient at increased risk of a local recurrence.

Trial Registration

clinicaltrials.gov Identifier: NCT00707174

Related Topics

    loading  Loading Related Articles