Three-Day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: Cosmetic Outcomes and Patient Satisfaction from a Phase II Trial

Abstract

Objective: To report cosmetic outcomes and patient satisfaction with ingenol disoxate (LEO 43204) used in a once-daily, three-day field treatment regimen in patients with actinic keratosis. Design: This was a phase II, multicenter, open-label trial (ClinicalTrials.gov: NCT02305888) involving 20 trial sites in the United States. Participants: Patients with between five and 20 clinically typical actinic keratoses lesions on the full face/250cm2 on the chest, 25cm2 to 250cm2 on the scalp, or 250cm2 on the trunk/extremities were included. Measurements: The assessment methods in this study included the examination of global photo-damage at Week 8; a cosmetic outcome questionnaire to evaluate the overall appearance and feel of the skin following treatment at Week 8; and a treatment satisfaction questionnaire for medication (TSQM) to evaluate patient satisfaction with treatment at Week 8. Results: Treatment adherence was high, with 97 percent of patients overall applying the full three-day regimen. Global photo-damage improvement was seen in 66, 69, and 72 percent of patients in the face/chest, scalp, and trunk/extremities groups, respectively. Improved overall appearance of the treatment area was reported by 95, 97, and 80 percent of patients in the face/chest, scalp, and trunk/extremities groups, respectively. In addition, overall feel of the treatment area was reported as improved by 92, 95, and 70 percent of patients in the face/chest, scalp, and trunk/extremities groups, respectively. Overall, the mean scores for all four treatment satisfaction questionnaires for medication domains were high in each treatment group, ranging from 66.7/100 to 91.3/100. In particular, mean scores for global satisfaction were 73.9/100, 79.7/100, 66.7/100 for the face/chest, scalp, and trunk/extremities groups, respectively. Conclusion: Actinic keratosis field treatment with ingenol disoxate provided favorable cosmetic benefits and high treatment satisfaction.

Keywords: Actinic keratosis; cosmetic outcomes; field treatment; ingenol disoxate; patient satisfaction.

Conflict of interest statement

FUNDING:This study was funded by LEO Pharma. DISCLOSURES:Dr. Berman reports that he is a consultant, investigator, and a member of the Speaker’s Bureau for LEO Pharma AS. Dr. Nahm reports he is an investigator for LEO Pharma AS. Ms. Østerdal and Dr. Petersen report they are employees of LEO Pharma AS. Dr. Siegel reports receiving compensation from LEO Pharma AS for lectures and advisory boards within the last two years.

Figures

FIGURE 1.

Trial design. TSQM: Treatment Satisfaction Questionnaire for Medication

FIGURE 2.

Global photo-damage outcome assessment at Week 8 by treatment group

FIGURE 3.

Mean change from baseline to Week 8 in photo-damage assessment scores

FIGURE 4.

Cosmetic outcome at Week 8

FIGURE 5.

TSQM at Week 8