Ingenol mebutate gel for actinic keratosis: the link between quality of life, treatment satisfaction, and clinical outcomes
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Ingenol mebutate gel for actinic keratosis: the link between quality of life, treatment satisfaction, and clinical outcomes. / Augustin, Matthias; Tu, John H; Knudsen, Kim Mark; Erntoft, Sandra; Larsson, Thomas; Hanke, C William.
In: J AM ACAD DERMATOL, Vol. 72, No. 5, 05.2015, p. 816-821.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Ingenol mebutate gel for actinic keratosis: the link between quality of life, treatment satisfaction, and clinical outcomes
AU - Augustin, Matthias
AU - Tu, John H
AU - Knudsen, Kim Mark
AU - Erntoft, Sandra
AU - Larsson, Thomas
AU - Hanke, C William
N1 - Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
PY - 2015/5
Y1 - 2015/5
N2 - BACKGROUND: Actinic keratosis therapy can elicit unsightly and painful local skin responses; assessment of treatment satisfaction and health-related quality of life (QoL) is important. Ingenol mebutate gel is a novel topical field therapy for actinic keratosis.OBJECTIVE: Post-hoc analyses were performed based on patient-reported outcomes from phase-III trials (n = 1005) to assess the effects of ingenol mebutate on QoL and the relationship between both QoL and treatment satisfaction, and degree of lesion clearance.METHODS: Patients received ingenol mebutate or vehicle for self-application to a 25-cm(2) contiguous area: 0.015% once daily for 3 consecutive days (face/scalp) or 0.05% once daily for 2 consecutive days (trunk/extremities). QoL (Skindex-16) and Treatment Satisfaction Questionnaire for Medication data were recorded.RESULTS: Significant, positive associations between Treatment Satisfaction Questionnaire for Medication score and degree of clearance were identified for patients in the face/scalp (effectiveness P < .0001 and global satisfaction P = .0002) and trunk/extremities (P < .0001 and P = .0014, respectively) groups. There was a significant association between Skindex-16 score and clearance for patients in the face/scalp group for change in symptoms (P = .0218), emotions (P = .0002), and overall Skindex-16 score (P = .0006) from baseline.LIMITATIONS: Clinical trial population findings may not be generalizable to clinical practice.CONCLUSION: Ingenol mebutate significantly improved patients' QoL and treatment satisfaction. Improvements were associated with higher degrees of actinic keratosis lesion clearance.
AB - BACKGROUND: Actinic keratosis therapy can elicit unsightly and painful local skin responses; assessment of treatment satisfaction and health-related quality of life (QoL) is important. Ingenol mebutate gel is a novel topical field therapy for actinic keratosis.OBJECTIVE: Post-hoc analyses were performed based on patient-reported outcomes from phase-III trials (n = 1005) to assess the effects of ingenol mebutate on QoL and the relationship between both QoL and treatment satisfaction, and degree of lesion clearance.METHODS: Patients received ingenol mebutate or vehicle for self-application to a 25-cm(2) contiguous area: 0.015% once daily for 3 consecutive days (face/scalp) or 0.05% once daily for 2 consecutive days (trunk/extremities). QoL (Skindex-16) and Treatment Satisfaction Questionnaire for Medication data were recorded.RESULTS: Significant, positive associations between Treatment Satisfaction Questionnaire for Medication score and degree of clearance were identified for patients in the face/scalp (effectiveness P < .0001 and global satisfaction P = .0002) and trunk/extremities (P < .0001 and P = .0014, respectively) groups. There was a significant association between Skindex-16 score and clearance for patients in the face/scalp group for change in symptoms (P = .0218), emotions (P = .0002), and overall Skindex-16 score (P = .0006) from baseline.LIMITATIONS: Clinical trial population findings may not be generalizable to clinical practice.CONCLUSION: Ingenol mebutate significantly improved patients' QoL and treatment satisfaction. Improvements were associated with higher degrees of actinic keratosis lesion clearance.
KW - Administration, Topical
KW - Diterpenes
KW - Drug Administration Schedule
KW - Gels
KW - Humans
KW - Keratosis, Actinic
KW - Patient Satisfaction
KW - Pharmaceutical Vehicles
KW - Quality of Life
KW - Self Administration
KW - Surveys and Questionnaires
KW - Treatment Outcome
U2 - 10.1016/j.jaad.2015.01.036
DO - 10.1016/j.jaad.2015.01.036
M3 - SCORING: Journal article
C2 - 25770879
VL - 72
SP - 816
EP - 821
JO - J AM ACAD DERMATOL
JF - J AM ACAD DERMATOL
SN - 0190-9622
IS - 5
ER -