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A randomized trial comparing simultaneous vs. sequential field treatment of actinic keratosis with ingenol mebutate on two separate areas of the head and body
Author(s) -
Pellacani G.,
Peris K.,
Guillen C.,
Clonier F.,
Larsson T.,
Venkata R.,
Puig S.
Publication year - 2015
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.13211
Subject(s) - medicine , actinic keratosis , tolerability , scalp , adverse effect , dermatology , trunk , randomized controlled trial , regimen , surgery , basal cell , ecology , biology
Background Actinic keratoses ( AK s) are precursors to invasive squamous cell carcinoma and can progress if untreated. Limited data support the use of ingenol mebutate to treat AK s on more than one area of the body simultaneously. Objective To investigate safety, efficacy and treatment satisfaction when treating separate areas simultaneously or sequentially with different concentrations of ingenol mebutate gel. Methods In this phase III b study ( NCT 01787383), patients with clinically visible, non‐hyperkeratotic AK s on two separate treatment areas (face/scalp and trunk/extremities) were randomized to simultaneous or sequential treatment with ingenol mebutate gel (0.015% and 0.05%). Endpoints included composite local skin response ( LSR ) score 3 days after first application, complete AK clearance and percentage reduction in AK s at week 8. Results There were no statistically significant differences between simultaneous ( n = 101) and sequential ( n = 98) groups in composite LSR score (10.4 vs. 9.7), complete clearance (52.7% vs. 46.9%) or percentage reduction in AK s (83.4% vs. 79.1%). Mean composite LSR scores on face/scalp and trunk/extremities were similar for both groups. Adverse event ( AE ) incidence was comparable between groups, the most common treatment‐related AE s being pruritus and pain at the application site. Conclusion Treating AK s with ingenol mebutate simultaneously or sequentially gave similar results in terms of tolerability ( LSR score, AE s) and efficacy (complete clearance). Therefore, the physician and patient can select the most convenient treatment regimen, with confidence in achieving a similar outcome.