0
Study |

Long-term Follow-up Study of Ingenol Mebutate Gel for the Treatment of Actinic Keratoses

Mark Lebwohl, MD; Stephen Shumack, MB, BS; Linda Stein Gold, MD; Anita Melgaard, MSc, Stat; Thomas Larsson, DrMedSci; Stephen K. Tyring, MD, PhD
JAMA Dermatol. 2013;149(6):666-670. doi:10.1001/jamadermatol.2013.2766.
Text Size: A A A
Published online

Importance Ingenol mebutate is the active agent (a macrocyclic diterpene ester) in the sap of the plant Euphorbia peplus. This herb has been used as a traditional remedy for several different skin lesions, including skin cancers.

Objective To assess 12-month recurrence rates and safety associated with ingenol mebutate gel treatment in patients who previously had achieved complete clearance of actinic keratoses.

Design and Setting The treatment area was observed for recurrence for 12 months after the original study. Patients were treated in an outpatient setting.

Participants Patients received ingenol mebutate gel, 0.015%, daily for 3 consecutive days for actinic keratoses on the face or scalp or ingenol mebutate gel, 0.05%, daily for 2 consecutive days for actinic keratoses on the trunk or extremities. Study participants had achieved complete clearance in a prespecified 25-cm2 area at day 57 of their original trial.

Main Outcome Measures Recurrence rates and safety were assessed.

Results In total, 108 patients with complete clearance of face or scalp lesions in the original trial and 76 patients with complete clearance of trunk or extremity lesions in the original trial were enrolled in the 12-month observational follow-up study. Of these, 100 patients (face or scalp) and 71 patients (trunk or extremities) completed all 12 months. The sustained lesion reduction rates compared with baseline were 87.2% for the face or scalp and 86.8% for the trunk or extremities. The estimated median times to recurrence were 365 days (face or scalp) and 274 days (trunk or extremities). There were no safety concerns during the follow-up period.

Conclusion and Relevance Ingenol mebutate gel applied as field therapy for 2 or 3 consecutive days to treat actinic keratoses produced clinically relevant sustained clearance and long-term lesion reduction.

Trial Registration clinicaltrials.gov Identifiers: NCT00953732, NCT00952783, and NCT00989313

Figures in this Article

Sign In to Access Full Content

Don't have Access?

Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours

Figures

Place holder to copy figure label and caption
Graphic Jump Location

Figure 1. Patient disposition among those who had achieved complete clearance of actinic keratoses with ingenol mebutate gel by day 57 of a previous study and who continued in a long-term follow-up study.

Place holder to copy figure label and caption
Graphic Jump Location

Figure 2. Probability of sustained actinic keratosis (AK) clearance on the face or scalp (A) and the trunk or extremities (B) across months (Kaplan-Meier estimate).

Tables

References

Correspondence

CME


You need to register in order to view this quiz.
NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).
Submit a Comment

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Web of Science® Times Cited: 3

Sign In to Access Full Content

Related Content

Customize your page view by dragging & repositioning the boxes below.

Multimedia Related by Topic
Articles Related By Topic
Related Topics
PubMed Articles
Jobs
brightcove.createExperiences();