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

Brian Berman; Stephen Tyring; Walter K Nahm; Marie Louise Østerdal; Astrid H Petersen; Daniel M Siegel

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

J Clin Aesthet Dermatol. 2017 Nov;10(11):26-32. Epub 2017 Nov 1.

Authors

Brian Berman^{1

2

3

4

5}, Stephen Tyring^{1

2

3

4

5}, Walter K Nahm^{1

2

3

4

5}, Marie Louise Østerdal^{1

2

3

4

5}, Astrid H Petersen^{1

2

3

4

5}, Daniel M Siegel^{1

2

3

4

5}

Affiliations

¹ Dr. Berman is Co-Director at Center for Clinical and Cosmetic Research in Aventura, Florida.
² Dr. Tyring is Medical Director at the Center for Clinical Studies at University of Texas Health Science Center in Houston, Texas.
³ Dr. Nahm is affiliated with the University of California, San Diego School of Medicine in San Diego, California, and is an investigator for LEO Pharma AS in Ballerup, Denmark. Ms. Østerdal.
⁴ Dr. Petersen are employees of LEO Pharma in Ballerup, Denmark AS.
⁵ Dr. Siegel is a practicing dermatologist at Long Island Skin Cancer and Dermatologic Surgery in New York, New York.

PMID: 29399258
PMCID: PMC5774908

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.

Associated data

ClinicalTrials.gov/NCT02305888