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Table 1 Text of Disclosure Statements Reviewed by Physicians

From: Influence of data disclosures on physician decisions about off-label uses: findings from a qualitative study

Disclosure Statement Text

1

Not an Approved Indication

Use of topical imiquimod as a neoadjuvant treatment of lentigo maligna is not an approved indication based on the current imiquimod US Prescribing Information

Other Data

Another study that used topical imiquimod to treat LM found a significantly increased rate of recurrence (9.6% within three years of follow up), compared to other studies of topical imiquimod. In addition, ten percent of the study’s initial patient sample had to withdraw due to adverse reactions to topical imiquimod. (Spangelo BD, Grosz OJH, Joyce JM. Effect of topical imiquimod as primary treatment for lentigo maligna: Results from a phase II clinical trial. Arch Dermatol. 2012;148(7):928 930.)

2

Not an Approved Indication

Use of topical imiquimod as a neoadjuvant treatment of lentigo maligna is not an approved indication based on the current imiquimod US Prescribing Information

Other Data

Another study investigating the use of topical imiquimod as a treatment strategy to prevent surgery for LM did not support the conclusion displayed here. (Spangelo BD, Grosz OJH, Joyce JM. Effect of topical imiquimod as primary treatment for lentigo maligna: Results from a phase II clinical trial. Arch Dermatol. 2012;148(7):928–930.)

3

Not an Approved Indication

Use of topical imiquimod as a neoadjuvant treatment of lentigo maligna is not an approved indication based on the current imiquimod US Prescribing Information

Other Data

Other study results may not support the conclusion(s) displayed here