Brian Berman1,2,3,4,5, Stephen Tyring1,2,3,4,5, Walter K Nahm1,2,3,4,5, Marie Louise Østerdal1,2,3,4,5, Astrid H Petersen1,2,3,4,5, Daniel M Siegel1,2,3,4,5. 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.
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.
RCT Entities:
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.
Authors: Marc Bourcier; Linda Stein Gold; Lyn Guenther; Camilla M Andreassen; Johan Selmer; Gary Goldenberg Journal: J Dermatolog Treat Date: 2017-04-04 Impact factor: 3.359
Authors: William C Hanke; Jenny M Norlin; Kim Mark Knudsen; Thomas Larsson; Stephen Stone Journal: J Dermatolog Treat Date: 2016-04-07 Impact factor: 3.359
Authors: Matthias Augustin; John H Tu; Kim Mark Knudsen; Sandra Erntoft; Thomas Larsson; C William Hanke Journal: J Am Acad Dermatol Date: 2015-03-11 Impact factor: 11.527
Authors: Daniel M Siegel; Stephen Tyring; Walter K Nahm; Marie Louise Østerdal; Astrid H Petersen; Brian Berman Journal: J Clin Aesthet Dermatol Date: 2017-12-01
Authors: Daniel M Siegel; Stephen Tyring; Walter K Nahm; Marie Louise Østerdal; Astrid H Petersen; Brian Berman Journal: J Clin Aesthet Dermatol Date: 2017-12-01