Academic Journal
Efficacy and safety of follow-up field treatment of actinic keratosis with ingenol mebutate 0·015% gel: a randomized, controlled 12-month study
| العنوان: | Efficacy and safety of follow-up field treatment of actinic keratosis with ingenol mebutate 0·015% gel: a randomized, controlled 12-month study |
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| المؤلفون: | Garbe, C., Basset-Seguin, N., Poulin, Y., Larsson, T., Østerdal, M.L., Venkata, R., Lear, J.T. |
| المساهمون: | LEO Pharma |
| المصدر: | British Journal of Dermatology ; volume 174, issue 3, page 505-513 ; ISSN 1365-2133 0007-0963 |
| بيانات النشر: | Oxford University Press (OUP) |
| سنة النشر: | 2016 |
| الوصف: | Summary Background Ingenol mebutate (IngMeb) is a novel patient-applied topical field therapy for actinic keratosis. Objectives To demonstrate the efficacy and safety of follow-up IngMeb field treatment of actinic keratoses (AKs) present at 8 weeks after initial treatment or emerging in a previously cleared field. Methods In this phase III, randomized, double-blind study in patients with 4–8 clinically visible AKs within a contiguous 25-cm2 treatment area on the face or scalp, all patients were treated initially with IngMeb 0·015% gel for three consecutive days. If lesions were present in the field at 8 weeks, or emerged at weeks 26 or 44, patients were randomized (2 : 1) to follow-up IngMeb or vehicle gel for three consecutive days. The main outcome was complete clearance rates of AKs 8 weeks after randomization. Results Of 450 patients who received initial treatment with IngMeb, 61·6% demonstrated complete clearance at 8 weeks. Patients with AKs present at 8 weeks or emerging at weeks 26 or 44 were randomized to IngMeb (n = 134) or vehicle (n = 69). IngMeb achieved a higher complete clearance rate than vehicle 8 weeks after randomization in AKs present at 8 weeks (46·7% vs. 18·4%; P < 0·01) and in emergent AKs (59·5% vs. 25·0%; P = 0·01). Based on those who completed 12 months of follow-up (n = 340), the overall 12-month clearance rate was estimated at 50·0%. Follow-up IngMeb treatment was well tolerated. Conclusions This study demonstrated the long-term benefit of IngMeb 0·015% gel for initial and follow-up therapy of AKs. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1111/bjd.14222 |
| الاتاحة: | http://dx.doi.org/10.1111/bjd.14222 https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1111%2Fbjd.14222 https://academic.oup.com/bjd/article-pdf/174/3/505/49716309/bjd0505.pdf |
| Rights: | https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model |
| رقم الانضمام: | edsbas.77F8CDFD |
| قاعدة البيانات: | BASE |
| DOI: | 10.1111/bjd.14222 |
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