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.

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.

• Authors: Mark A Hyde, Michael L Hadley, Payam Tristani-Firouzi, David Goldgar, Glen M Bowen
• Journal: Archives of dermatology (Arch Dermatol) Vol. 148 Issue 5 Pg. 592-6 (May 2012) ISSN: 1538-3652 [Electronic] United States
• PMID: 22431716 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Aminoquinolines
• Antineoplastic Agents
• Dermatologic Agents
• Gels
• Nicotinic Acids
• Ointments
• tazarotene
• Imiquimod

Topics

• Administration, Topical
• Adult
• Aged
• Aged, 80 and over
• Aminoquinolines (administration & dosage)
• Antineoplastic Agents (administration & dosage)
• Biopsy
• Cheek
• Dermatologic Agents (administration & dosage)
• Diagnosis, Differential
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Drug Therapy, Combination
• Follow-Up Studies
• Gels
• Humans
• Hutchinson's Melanotic Freckle (diagnosis, drug therapy, surgery)
• Imiquimod
• Middle Aged
• Mohs Surgery (methods)
• Nicotinic Acids (administration & dosage)
• Off-Label Use
• Ointments
• Postoperative Care (methods)
• Prospective Studies
• Skin Neoplasms (diagnosis, drug therapy, surgery)
• Treatment Outcome