William C Hanke1, Jenny M Norlin2, Kim Mark Knudsen2, Thomas Larsson2, Stephen Stone3. 1. a Indiana University School of Medicine , Indianapolis , IN , USA ; 2. b LEO Pharma A/S , Ballerup , Denmark ; 3. c Division of Dermatology , Southern Illinois University School of Medicine , Springfield , IN , USA.
Abstract
BACKGROUND: Treatments for actinic keratosis (AK) can elicit adverse local skin responses (LSRs). Knowledge regarding the burden of AK treatment on health related quality of life (HRQoL) is however limited. OBJECTIVES: To investigate whether treatment of AK improved HRQoL; to assess whether LSRs had an impact on HRQoL during treatment and to analyze the relationship between LSRs and HRQoL. METHODS:Patients (n = 329) were randomized for treatment with cryosurgery (CRY) followed by ingenol mebutate (IngMeb) (CRY + IngMeb) or CRY followed by vehicle (CRY + vehicle). HRQoL was analyzed using DLQI, EQ-5D and EQ-VAS at baseline, three days, two weeks and eight weeks post treatment. RESULTS: Statistically significant HRQoL improvements were seen in all measures in both treatment groups (p < 0.001). Impairments in DLQI in CRY + IngMeb at LSR peak were within a range interpreted as having "a small impact on patients' life" (2-5), which normalized within two weeks. LIMITATIONS: DLQI may not be sensitive to change in the AK disease as it mainly captures symptoms and has a limited focus on feelings. CONCLUSION: The treatment burden of IngMeb is small, manageable and short-lasting. Since AK is a chronic condition, often requiring repeated treatment courses, combining treatments that provide enhanced effectiveness, while limiting HRQoL impairment is essential.
RCT Entities:
BACKGROUND: Treatments for actinic keratosis (AK) can elicit adverse local skin responses (LSRs). Knowledge regarding the burden of AK treatment on health related quality of life (HRQoL) is however limited. OBJECTIVES: To investigate whether treatment of AK improved HRQoL; to assess whether LSRs had an impact on HRQoL during treatment and to analyze the relationship between LSRs and HRQoL. METHODS:Patients (n = 329) were randomized for treatment with cryosurgery (CRY) followed by ingenol mebutate (IngMeb) (CRY + IngMeb) or CRY followed by vehicle (CRY + vehicle). HRQoL was analyzed using DLQI, EQ-5D and EQ-VAS at baseline, three days, two weeks and eight weeks post treatment. RESULTS: Statistically significant HRQoL improvements were seen in all measures in both treatment groups (p < 0.001). Impairments in DLQI in CRY + IngMeb at LSR peak were within a range interpreted as having "a small impact on patients' life" (2-5), which normalized within two weeks. LIMITATIONS: DLQI may not be sensitive to change in the AK disease as it mainly captures symptoms and has a limited focus on feelings. CONCLUSION: The treatment burden of IngMeb is small, manageable and short-lasting. Since AK is a chronic condition, often requiring repeated treatment courses, combining treatments that provide enhanced effectiveness, while limiting HRQoL impairment is essential.
Entities:
Keywords:
Actinic keratosis; DLQI; EQ-5D; health related ouality of life; ingenol mebutate gel; local skin responses
Authors: Brian Berman; Stephen Tyring; Walter K Nahm; Marie Louise Østerdal; Astrid H Petersen; Daniel M Siegel Journal: J Clin Aesthet Dermatol Date: 2017-11-01