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Patients with multiple actinic keratoses (AKs) may be treated either sequentially or simultaneously with ingenol mebutate gel, according to the authors of a study that found no difference in outcomes or adverse effects from either treatment approach.
The phase IIIb study conducted in Italy and Spain enrolled 199 patients with two separate areas of clinically visible, nonhyperkeratotic AKs. Subjects were randomized to have the two areas (face/scalp and trunk/extremities) treated simultaneously (101 patients) or sequentially (98 patients) with 0.015% and 0.05% ingenol mebutate gel.
There were no significant differences in localized skin responses between the simultaneous and sequential treatment groups, based on the mean composite local skin response scores 3 days after treatment started, which were similar between the groups for the face/scalp and trunk/extremities applications. About 22% of patients in each group experienced adverse events.
At 8 weeks, the complete clearance rates also were not statistically different between the simultaneous and sequential groups (52.7% and 46.9%, respectively; P = .34), and patient satisfaction with treatment was similar for both treatment approaches. At that time, the number of AKs had dropped by a mean of 83.4% among those in the simultaneous group and 79.1% in the sequential group (P = .20).
“The favorable rate of complete clearance in the simultaneous treatment group means that patients can receive their treatment for both areas in one visit, rather than having to return to the clinic for a second cycle of treatment,” wrote Dr. Giovanni Pellacani of the department of dermatology at the University of Modena (Italy) and Reggio Emilia, and his coauthors (J Eur Acad Dermatol Venereol. 2015;29[11]:2192-8).
“Ultimately, the treatment schedule is based on agreement between the physician and the patient; this study helps to support the selection of the most appropriate regimen to treat AK in individual patients,” they commented.
The study was funded by LEO Pharma, the manufacturer of ingenol mebutate gel (Picato). Dr. Pellacani has received consultant fees from the company; three authors are employees of the company; and the other authors declared consultancies, honoraria and, grants from LEO Pharma and other pharmaceutical companies.
Patients with multiple actinic keratoses (AKs) may be treated either sequentially or simultaneously with ingenol mebutate gel, according to the authors of a study that found no difference in outcomes or adverse effects from either treatment approach.
The phase IIIb study conducted in Italy and Spain enrolled 199 patients with two separate areas of clinically visible, nonhyperkeratotic AKs. Subjects were randomized to have the two areas (face/scalp and trunk/extremities) treated simultaneously (101 patients) or sequentially (98 patients) with 0.015% and 0.05% ingenol mebutate gel.
There were no significant differences in localized skin responses between the simultaneous and sequential treatment groups, based on the mean composite local skin response scores 3 days after treatment started, which were similar between the groups for the face/scalp and trunk/extremities applications. About 22% of patients in each group experienced adverse events.
At 8 weeks, the complete clearance rates also were not statistically different between the simultaneous and sequential groups (52.7% and 46.9%, respectively; P = .34), and patient satisfaction with treatment was similar for both treatment approaches. At that time, the number of AKs had dropped by a mean of 83.4% among those in the simultaneous group and 79.1% in the sequential group (P = .20).
“The favorable rate of complete clearance in the simultaneous treatment group means that patients can receive their treatment for both areas in one visit, rather than having to return to the clinic for a second cycle of treatment,” wrote Dr. Giovanni Pellacani of the department of dermatology at the University of Modena (Italy) and Reggio Emilia, and his coauthors (J Eur Acad Dermatol Venereol. 2015;29[11]:2192-8).
“Ultimately, the treatment schedule is based on agreement between the physician and the patient; this study helps to support the selection of the most appropriate regimen to treat AK in individual patients,” they commented.
The study was funded by LEO Pharma, the manufacturer of ingenol mebutate gel (Picato). Dr. Pellacani has received consultant fees from the company; three authors are employees of the company; and the other authors declared consultancies, honoraria and, grants from LEO Pharma and other pharmaceutical companies.
Patients with multiple actinic keratoses (AKs) may be treated either sequentially or simultaneously with ingenol mebutate gel, according to the authors of a study that found no difference in outcomes or adverse effects from either treatment approach.
The phase IIIb study conducted in Italy and Spain enrolled 199 patients with two separate areas of clinically visible, nonhyperkeratotic AKs. Subjects were randomized to have the two areas (face/scalp and trunk/extremities) treated simultaneously (101 patients) or sequentially (98 patients) with 0.015% and 0.05% ingenol mebutate gel.
There were no significant differences in localized skin responses between the simultaneous and sequential treatment groups, based on the mean composite local skin response scores 3 days after treatment started, which were similar between the groups for the face/scalp and trunk/extremities applications. About 22% of patients in each group experienced adverse events.
At 8 weeks, the complete clearance rates also were not statistically different between the simultaneous and sequential groups (52.7% and 46.9%, respectively; P = .34), and patient satisfaction with treatment was similar for both treatment approaches. At that time, the number of AKs had dropped by a mean of 83.4% among those in the simultaneous group and 79.1% in the sequential group (P = .20).
“The favorable rate of complete clearance in the simultaneous treatment group means that patients can receive their treatment for both areas in one visit, rather than having to return to the clinic for a second cycle of treatment,” wrote Dr. Giovanni Pellacani of the department of dermatology at the University of Modena (Italy) and Reggio Emilia, and his coauthors (J Eur Acad Dermatol Venereol. 2015;29[11]:2192-8).
“Ultimately, the treatment schedule is based on agreement between the physician and the patient; this study helps to support the selection of the most appropriate regimen to treat AK in individual patients,” they commented.
The study was funded by LEO Pharma, the manufacturer of ingenol mebutate gel (Picato). Dr. Pellacani has received consultant fees from the company; three authors are employees of the company; and the other authors declared consultancies, honoraria and, grants from LEO Pharma and other pharmaceutical companies.
FROM THE JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
Key clinical point: Patients with multiple AKs may be treated either sequentially or simultaneously with ingenol mebutate gel, with similar efficacy and safety outcomes.
Major finding: The incidence of localized skin responses, complete clearance rates, and patient treatment satisfaction were similar for simultaneous and sequential treatment approaches.
Data source: A phase IIIb randomized, multicenter, open-label, parallel-group study evaluated 199 patients with two separate areas of clinically visible, nonhyperkeratotic AKs.
Disclosures: The study was funded by ingenol mebutate gel manufacturer LEO Pharma. Three authors are employees of the company; the other authors declared consultancies, honoraria, and/or grants from LEO Pharma and other pharmaceutical companies.
