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J Am Acad Dermatol. 2015 May;72(5):816-21. doi: 10.1016/j.jaad.2015.01.036. Epub 2015 Mar 11.

Ingenol mebutate gel for actinic keratosis: the link between quality of life, treatment satisfaction, and clinical outcomes.

Author information

1
German Center for Health Services Research in Dermatology, University Medical Center, Hamburg, Germany. Electronic address: m.augustin@uke.de.
2
Dermatology Associates of Rochester, Rochester, New York; Department of Dermatology, University of Rochester School of Medicine and Dentistry, Rochester, New York.
3
LEO Pharma A/S, Ballerup, Denmark.
4
Indiana University School of Medicine, Indianapolis, Indiana.

Abstract

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.

KEYWORDS:

Skindex-16; Treatment Satisfaction Questionnaire for Medication; actinic keratosis; clearance; ingenol mebutate; quality of life

PMID:
25770879
DOI:
10.1016/j.jaad.2015.01.036
[Indexed for MEDLINE]

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