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Gary Goldenberg - One of the best experts on this subject based on the ideXlab platform.
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an investigator initiated study to assess the safety and efficacy of ingenol mebutate 0 05 gel when used after Cryosurgery in the treatment of hypertrophic actinic keratosis on dorsal hands
The Journal of clinical and aesthetic dermatology, 2016Co-Authors: Peter W Hashim, John K. Nia, Skylar Singer, Gary GoldenbergAbstract:Objectives: To evaluate the safety and efficacy of ingenol mebutate 0.05% gel after Cryosurgery versus Cryosurgery alone for the treatment of hypertrophic and nonhypertrophic actinic keratosis on the dorsal hands. Design: Investigator-blinded split arm study. Setting: Academic institution. Participants: Sixteen subjects with actinic keratoses on dorsal hands. Results: There was a mean reduction in the number of hypertrophic actinic keratosis lesions adjusted for baseline in ingenol mebutate-treated versus control group of -4.3 versus -2.8, respectively. There was a mean reduction in the number of non-hypertrophic actinic keratosis lesions in the ingenol mebutate-treated versus control group of -3.8 versus -0.3. Conclusion: A statistically significant and clinically meaningful difference in response was demonstrated in favor of ingenol mebutate-treated hands versus controls. No significant increase in local skin responses was noted when applying ingenol mebutate 0.05% gel on the same day as Cryosurgery. Trial registry: ClinicalTrials.gov, {"type":"clinical-trial","attrs":{"text":"NCT02251652","term_id":"NCT02251652"}}NCT02251652.
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efficacy and safety of ingenol mebutate 0 015 gel after Cryosurgery of actinic keratosis 12 month results
Journal of Drugs in Dermatology, 2014Co-Authors: Brian Berman, William C Hanke, Wm Philip Werschler, Kim Mark Knudsen, Gary Goldenberg, Stephen K. Tyring, Thomas Larsson, Neil A SwansonAbstract:INTRODUCTION: Recurrence rates of actinic keratosis (AK) lesions after Cryosurgery are high, and this treatment does not address field cancerization. We investigated the efficacy and safety of field treatment of AKs with ingenol mebutate gel following Cryosurgery. METHODS: In this phase 3, randomized, double-blind, vehicle-controlled study (NCT01541553), patients ≥18 years with four to eight clinically typical, visible, discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp underwent Cryosurgery followed 3 weeks later by once-daily ingenol mebutate 0.015% or vehicle gel for 3 consecutive days. Endpoints included complete clearance at week 11 and safety and efficacy over 12 months. RESULTS: In 329 randomized patients, complete clearance rates were greater with ingenol mebutate than vehicle (week 11: 60.5% vs 49.4%; P=.04; month 12: 30.5% vs 18.5%; P=.01). Fewer patients experienced the emergence of new lesions with ingenol mebutate than with vehicle (38.9% vs 51.9%; P =.02). At month 12, mean percentage reduction of AKs was higher with ingenol mebutate than with vehicle (68.2% vs 54.1%; P =.002). The probability of remaining free of lesions was sustained longer with ingenol mebutate compared with vehicle gel: 78% vs 68% at 6 months; 64% vs 57% at 9 months; 55% vs 40% at month 12, respectively. Ingenol mebutate 0.015% gel was well tolerated and no unexpected adverse events occurred; all adverse events resolved within 2 weeks of starting treatment. CONCLUSIONS: Field treatment with ingenol mebutate 0.015% gel following Cryosurgery significantly enhanced clearance of baseline lesions, and was well tolerated. Furthermore, ingenol mebutate 0.015% gel following Cryosurgery reduced development of new lesions in the treated field.
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efficacy and safety of ingenol mebutate 0 015 gel 3 weeks after Cryosurgery of actinic keratosis 11 week results
Journal of Drugs in Dermatology, 2014Co-Authors: Brian Berman, William C Hanke, Wm Philip Werschler, Kim Mark Knudsen, Torsten Skov, Joana Carla Soares Goncalves, Gary Goldenberg, Stephen K. Tyring, Thomas Larsson, Neil A SwansonAbstract:INTRODUCTION: Cryosurgery is the most common treatment for actinic keratosis (AK) in the United States. Efficacy with Cryosurgery is variable, and is a modality for treating individual, visible lesions while failing to treat subclinical lesions. METHODS: FIELD Study 1 (NCT01541553) is a phase 3, multicenter, randomized, double-blind study that evaluated the short- (11-week) and long- (12-month) term efficacy and safety of sequential AK treatment using Cryosurgery with liquid nitrogen followed by ingenol mebutate gel, versus Cryosurgery followed by vehicle. RESULTS: Overall, 329 patients were randomized to ingenol mebutate 0.015% gel (n=167) or vehicle (n=162) 3 weeks after Cryosurgery. Baseline characteristics were balanced across groups. At week 11, complete clearance rate (100%) in the treatment area was higher for ingenol mebutate gel compared with vehicle (60.5% vs 49.4%, respectively; P=.04). Mean percentage reduction in number of AKs versus baseline was also numerically higher for ingenol mebutate gel (82.7% vs 75.6%). A general reduction from baseline lesion count was observed 3 weeks after Cryosurgery. Treatment after Cryosurgery was well tolerated. CONCLUSIONS: Short-term (11-week) AK clearance rates on the face or scalp with ingenol mebutate gel after Cryosurgery were higher than with Cryosurgery alone.
R P H Veth - One of the best experts on this subject based on the ideXlab platform.
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aneurysmal bone cyst the role of Cryosurgery as local adjuvant treatment
Journal of Surgical Oncology, 2009Co-Authors: S P Peeters, R P H Veth, I C M Van Der Geest, J W J De Rooy, H W B SchreuderAbstract:BACKGROUND: Aneurysmal bone cysts (ABCs) are most often treated with intralesional surgery (curettage) and additional bone grafting. There is debate on whether or not to use adjuvant therapy to decrease the local recurrence rate. This study is done to assess the outcome of curettage and Cryosurgery as a treatment of ABC. METHODS: We analyzed 80 consecutive cases of ABC treated with curettage and Cryosurgery. Patients were followed minimal 24 months after surgery (average 55 months, range 24-122 months) with physical examination and radiographs. Functional outcome was evaluated using the musculoskeletal tumor society score (MSTS). RESULTS: The 80 patients were all treated with curettage and Cryosurgery. Additional bone grafting was used in 73 patients, osteosynthesis in 12 and spondylodesis in 1 patient. Four local recurrences were found in this study, a recurrence rate of 5%. All local recurrences were treated successfully with curettage and Cryosurgery again 7-33 months after the initial surgery. Postoperative one fracture, one wound infection, and three transient nerve palsy occurred. The average MSTS score was 29.2 at follow-up. CONCLUSIONS: The use of Cryosurgery as adjuvant therapy results in a lower local recurrence rate when compared to other publications for the treatment of ABC and excellent functional results.
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the cryosurgical treatment of chondroblastoma of bone long term oncologic and functional results
Journal of Surgical Oncology, 2007Co-Authors: Ingrid C M Van Der Geest, M Pruszczynski, Jacky W J De Rooy, Marinel P Van Noort, H Bart W Schreuder, R P H VethAbstract:BACKGROUND: Chondroblastoma of bone is a rare tumor that occurs most often in the epiphysis or apophysis of long bones. This benign tumor sometimes shows aggressive or malignant behaviour, and rarely metastases occur. Since wide resection often leads to growth impairment, intra-lesional curettage followed by an adjuvant therapy is developed to decrease the negative effects on growth and function without increased recurrence rates. PATIENTS AND METHODS: Between 1980 and 2001, 18 patients were treated for chondroblastoma of bone. Since 1989 Cryosurgery has been used as an adjuvant treatment. The functional and oncologic results at follow-up were studied. RESULTS: Four patients were treated with curettage, and four with wide resection without adjuvant therapy. One patient developed a local recurrence and distant metastases. Ten patients were treated with curettage and Cryosurgery. One patient developed a local recurrence 6 years later that was treated with curettage and Cryosurgery again. No serious complications from Cryosurgery occurred and the functional results at follow-up were excellent [mean MSTS score at follow-up 29]. CONCLUSIONS: Chondroblastoma of bone is a benign tumor with a relatively high recurrence rate. The local recurrence rates can be decreased with Cryosurgery as a local adjuvant therapy with excellent functional results.
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Cryosurgery in aggressive benign and low grade malignant bone tumours
Lancet Oncology, 2005Co-Authors: R P H Veth, Bart Schreuder, Herman Van Beem, M Pruszczynski, Jacky W J De RooyAbstract:Summary Cryosurgery is a method of treatment for various tumours that induces tissue necrosis with ablative intent. It is used in benign, aggressive, and low-grade malignant bone tumours such as chondrosarcoma grade 1. We describe the history of the technique and the issues associated with cryobiology, as well as the indications, technique, complications, and results of Cryosurgery. At the University Medical Centre Nijmegen, Netherlands, 302 tumours have been treated by use of Cryosurgery with at least 2 years' follow-up. 96–100% of patients were cured—the response depended on tumour type. Comparison of functional results with data from studies shows that these results concur with other studies on Cryosurgery, and are at least equal to results of marginal excision and mostly better than those of wide excisions of grade 1 chondrosarcomas. Thus from an oncological point of view, Cryosurgery combined with intralesional excision is equal to marginal excision.
Kim Mark Knudsen - One of the best experts on this subject based on the ideXlab platform.
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variables in Cryosurgery technique associated with clearance of actinic keratosis
Dermatologic Surgery, 2017Co-Authors: Brian Berman, Arsalan Shabbir, Tanya Macneil, Kim Mark KnudsenAbstract:Cryosurgery is the most commonly used method to treat actinic keratosis (AK). Cryosurgical methods are not standardized. To examine differences in the spray techniques used for liquid nitrogen Cryosurgery when treating AKs of the head, and the effect of these variations in technique on rates of complete clearance of AKs. Patients were those from the FIELD-1 study, who received Cryosurgery as per the investigators' usual practice to all AKs. This was followed by topical treatment with either vehicle gel or ingenol mebutate gel, 0.015%, after 3 weeks. The investigator recorded the average duration of Cryosurgery spray used, the number of freeze–thaw cycles, and the distance from the tip of the spray device to the AK. Clearance rates were determined at Week 11. Less-aggressive freezing techniques were used for AKs on the face than for those on the scalp. However, higher rates of complete clearance on the face and scalp were associated with more-aggressive freezing techniques. Patients with AKs on the face receive less-aggressive Cryosurgery than do patients with AKs on the scalp.
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efficacy and safety of ingenol mebutate 0 015 gel after Cryosurgery of actinic keratosis 12 month results
Journal of Drugs in Dermatology, 2014Co-Authors: Brian Berman, William C Hanke, Wm Philip Werschler, Kim Mark Knudsen, Gary Goldenberg, Stephen K. Tyring, Thomas Larsson, Neil A SwansonAbstract:INTRODUCTION: Recurrence rates of actinic keratosis (AK) lesions after Cryosurgery are high, and this treatment does not address field cancerization. We investigated the efficacy and safety of field treatment of AKs with ingenol mebutate gel following Cryosurgery. METHODS: In this phase 3, randomized, double-blind, vehicle-controlled study (NCT01541553), patients ≥18 years with four to eight clinically typical, visible, discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp underwent Cryosurgery followed 3 weeks later by once-daily ingenol mebutate 0.015% or vehicle gel for 3 consecutive days. Endpoints included complete clearance at week 11 and safety and efficacy over 12 months. RESULTS: In 329 randomized patients, complete clearance rates were greater with ingenol mebutate than vehicle (week 11: 60.5% vs 49.4%; P=.04; month 12: 30.5% vs 18.5%; P=.01). Fewer patients experienced the emergence of new lesions with ingenol mebutate than with vehicle (38.9% vs 51.9%; P =.02). At month 12, mean percentage reduction of AKs was higher with ingenol mebutate than with vehicle (68.2% vs 54.1%; P =.002). The probability of remaining free of lesions was sustained longer with ingenol mebutate compared with vehicle gel: 78% vs 68% at 6 months; 64% vs 57% at 9 months; 55% vs 40% at month 12, respectively. Ingenol mebutate 0.015% gel was well tolerated and no unexpected adverse events occurred; all adverse events resolved within 2 weeks of starting treatment. CONCLUSIONS: Field treatment with ingenol mebutate 0.015% gel following Cryosurgery significantly enhanced clearance of baseline lesions, and was well tolerated. Furthermore, ingenol mebutate 0.015% gel following Cryosurgery reduced development of new lesions in the treated field.
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efficacy and safety of ingenol mebutate 0 015 gel 3 weeks after Cryosurgery of actinic keratosis 11 week results
Journal of Drugs in Dermatology, 2014Co-Authors: Brian Berman, William C Hanke, Wm Philip Werschler, Kim Mark Knudsen, Torsten Skov, Joana Carla Soares Goncalves, Gary Goldenberg, Stephen K. Tyring, Thomas Larsson, Neil A SwansonAbstract:INTRODUCTION: Cryosurgery is the most common treatment for actinic keratosis (AK) in the United States. Efficacy with Cryosurgery is variable, and is a modality for treating individual, visible lesions while failing to treat subclinical lesions. METHODS: FIELD Study 1 (NCT01541553) is a phase 3, multicenter, randomized, double-blind study that evaluated the short- (11-week) and long- (12-month) term efficacy and safety of sequential AK treatment using Cryosurgery with liquid nitrogen followed by ingenol mebutate gel, versus Cryosurgery followed by vehicle. RESULTS: Overall, 329 patients were randomized to ingenol mebutate 0.015% gel (n=167) or vehicle (n=162) 3 weeks after Cryosurgery. Baseline characteristics were balanced across groups. At week 11, complete clearance rate (100%) in the treatment area was higher for ingenol mebutate gel compared with vehicle (60.5% vs 49.4%, respectively; P=.04). Mean percentage reduction in number of AKs versus baseline was also numerically higher for ingenol mebutate gel (82.7% vs 75.6%). A general reduction from baseline lesion count was observed 3 weeks after Cryosurgery. Treatment after Cryosurgery was well tolerated. CONCLUSIONS: Short-term (11-week) AK clearance rates on the face or scalp with ingenol mebutate gel after Cryosurgery were higher than with Cryosurgery alone.
Gang Zhao - One of the best experts on this subject based on the ideXlab platform.
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enhanced killing of hepg2 during Cryosurgery with fe 3 o 4 nanoparticle improved intracellular ice formation and cell dehydration
Oncotarget, 2017Co-Authors: Fuquan Yuan, Gang Zhao, Fazil PanhwarAbstract:// Fuquan Yuan 1 , Gang Zhao 1, 2 and Fazil Panhwar 1 1 Center for Biomedical Engineering, Department of Electronic Science and Technology, University of Science and Technology of China, Hefei 230027, Anhui, China 2 Anhui Provincial Engineering Research Center for Biopreservation and Artificial Organs, Hefei 230027, Anhui, China Correspondence to: Gang Zhao, email: zhaog@ustc.edu.cn Keywords: Cryosurgery, Fe 3 O 4 nanoparticles, intracellular ice formation, cell dehydration, killing efficiency Received: June 20, 2017 Accepted: September 08, 2017 Published: October 05, 2017 ABSTRACT Cryosurgery is a minimally invasive treatment that utilize extreme low temperatures to destroy abnormal tissues. The clinical monitoring methods for Cryosurgery are almost based on the visualization of the iceball. However, for a normal Cryosurgery process, the effective killing region is always smaller than the iceball. As a result, the end of the Cryosurgery process can only be judged by the surgeons according to their experience. The subjective judgement is one of the main reasons for poor estimation of tumor ablation, and it sparks high probability of recurrence and metastasis associate with Cryosurgery. Being different from the previous optimization studies, we develop a novel approach with the aid of nanoparticles to enlarge the effective killing region of entire iceball, and thus it greatly decrease the difficulty of precise judgement of the Cryosurgery only by applying the common clinical imaging methods. To verify this approach, both the experiments on a tissue-scale phantom with embedded living HepG2 cells in agarose and on a cell-scale cryo-microscopic freeze-thaw stage are performed. The results indicate that the introduction of the self-synthesized Fe 3 O 4 nanoparticles significantly improved cell killing in the Cryosurgery and the range of killing is extended to the entire iceball. The potential mechanism is further revealed by the cryo-microscopic experiments, which verifies the presence of Fe 3 O 4 nanoparticles can significantly enhance the probability of intracellular ice formation and the cell dehydration during freezing hence it promote precise killing of the cells. These findings may further promote the widespread clinical application of modern Cryosurgery.
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two phase heat transfer model for multiprobe Cryosurgery
Applied Thermal Engineering, 2017Co-Authors: Xin Zhang, Gang Zhao, S Chapal M Hossain, Beisheng QiuAbstract:Cryosurgery has been studied as an effective alternative to the conventional chemo and radiotherapies for treating various diseases including cancer. However, it is difficult to accurately quantify the temperature for determining the cell injury in tissue during Cryosurgery. One way to overcome this difficulty is to develop numerical models to predict the temperature distribution during Cryosurgery. However, contemporary models do not account for the fluid flow and heat transfer inside the cryoprobe(s) and its coupling with the heat transfer in the tissue outside the cryoprobe. In this study, we developed a two-phase flow model to predict the temperature distributions within multiple cryoprobe(s) and further coupled it with the heat transfer in the tissue, to reveal the synergistic effects among the cryoprobes on multi-probe Cryosurgery. Our results show that coupled modeling of the heat transfer inside and outside the cryoprobes is crucial for accurate prediction of the cooling power of cryoprobes during multi-probe Cryosurgery. The coupled model developed in this study represents a major step forward in mechanistically modeling Cryosurgery and may be a valuable tool for optimizing the design of cryoprobes and the procedure of Cryosurgery for treating various diseases.
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effect of vascular network and nanoparticles on heat transfer and intracellular ice formation in tumor tissues during Cryosurgery
Cryo letters, 2014Co-Authors: Gang Zhao, Yuntian ZhangAbstract:BACKGROUND Cryosurgery is a physical therapy of tumor treatment which is welcome in clinics for its minimally invasive advantage. However, the high recurrence rate makes the conventional Cryosurgery unsatisfactory, which needs adjuvant treatment such as introduction of nanoparticles. OBJECTIVE This study is to examine the effects of vascular network and MgO nanoparticles on heat transfer and intracellular ice formation in tumor tissues during Cryosurgery. METHOD We developed a multi-scale model to study the efficiency of Cryosurgery, including the macro-level (mass tumor tissue) heat transfer and the micro-level (tumor cells) probability of intracellular ice formation (PIF). The model is used to examine the effects of fractal vascular network (VN) and nanoparticles with different concentration on heat transfer and PIF during Cryosurgery in the breast cancer tissue (MCF-7 cells). The nucleation rate kinetic parameter and the thermodynamic parameter of MCF-7 cells are determined by nonlinear curve-fitting the published experimental data, and then the probability of intracellular ice formation of the picked points in the tumor tissue are determined using the classic model for intracellular ice nucleation with the simulated thermal profiles at those points during Cryosurgery. RESULTS AND CONCLUSION The introduction of nanoparticles have significantly enhanced the heat transfer in the mass tumor tissue and increased the PIF of tumor cells, indicating the nanoCryosurgery is more efficient than conventional Cryosurgery.
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effect of vascular network on conventional Cryosurgery and nano Cryosurgery
Volume 1A: Abdominal Aortic Aneurysms; Active and Reactive Soft Matter; Atherosclerosis; BioFluid Mechanics; Education; Biotransport Phenomena; Bone J, 2013Co-Authors: Gang Zhao, Weiping Ding, Dayong GaoAbstract:Cryosurgery is a physical therapy of tumor treatment, which is becoming more and more popular recent years due to its important clinical merit1. However, in many clinical cases, treatment by Cryosurgery has high recurrence rate, especially for tumors in some internal organs, such as liver. Most of these recurrent cases are caused by the low freezing efficiency, for example, it can’t destroy all the tumor cells especially the cells in the edge of the tumor or near the vascular network during conventional Cryosurgery process. In view of this, Liu et al. proposed a new surgical strategy, “nano-Cryosurgery”, to enhance freezing efficiency2.Copyright © 2013 by ASME
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effect of blood flow and metabolism on multidimensional heat transfer during Cryosurgery
Medical Engineering & Physics, 2007Co-Authors: Gang Zhao, Haifeng Zhang, Xiaojie Guo, Dawei Luo, Dayong GaoAbstract:Cryosurgery has been recently accepted as a treatment option for eradicating undesirable tissues, especially tumor tissues, due to its minimally invasive nature and low hospitalization needs. A multidimensional, finite element analysis (FEA) for the cooling, holding and rewarming processes of biological tissues during Cryosurgery is presented. The tissues were treated as non-ideal materials with temperature dependent thermophysical properties. The enthalpy method has been applied to solve the non-linear problem. The influence of heating effect due to blood flow and metabolism was studied, and furthermore, the effect of pre-injecting solutions with particular thermal properties into the target tissues was also numerically studied. It was found that the heat source term due to blood flow and metabolism in the bioheat transfer equation has a significant influence on the thermal and thermal gradient histories of the target tissues, and that the method of injection of solutions with particular thermal properties into the target tissues before Cryosurgery may be a possible way to optimize the treatment process. However, in vitro experiments have not fully supported this viewpoint.
Brian Berman - One of the best experts on this subject based on the ideXlab platform.
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variables in Cryosurgery technique associated with clearance of actinic keratosis
Dermatologic Surgery, 2017Co-Authors: Brian Berman, Arsalan Shabbir, Tanya Macneil, Kim Mark KnudsenAbstract:Cryosurgery is the most commonly used method to treat actinic keratosis (AK). Cryosurgical methods are not standardized. To examine differences in the spray techniques used for liquid nitrogen Cryosurgery when treating AKs of the head, and the effect of these variations in technique on rates of complete clearance of AKs. Patients were those from the FIELD-1 study, who received Cryosurgery as per the investigators' usual practice to all AKs. This was followed by topical treatment with either vehicle gel or ingenol mebutate gel, 0.015%, after 3 weeks. The investigator recorded the average duration of Cryosurgery spray used, the number of freeze–thaw cycles, and the distance from the tip of the spray device to the AK. Clearance rates were determined at Week 11. Less-aggressive freezing techniques were used for AKs on the face than for those on the scalp. However, higher rates of complete clearance on the face and scalp were associated with more-aggressive freezing techniques. Patients with AKs on the face receive less-aggressive Cryosurgery than do patients with AKs on the scalp.
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efficacy and safety of ingenol mebutate 0 015 gel after Cryosurgery of actinic keratosis 12 month results
Journal of Drugs in Dermatology, 2014Co-Authors: Brian Berman, William C Hanke, Wm Philip Werschler, Kim Mark Knudsen, Gary Goldenberg, Stephen K. Tyring, Thomas Larsson, Neil A SwansonAbstract:INTRODUCTION: Recurrence rates of actinic keratosis (AK) lesions after Cryosurgery are high, and this treatment does not address field cancerization. We investigated the efficacy and safety of field treatment of AKs with ingenol mebutate gel following Cryosurgery. METHODS: In this phase 3, randomized, double-blind, vehicle-controlled study (NCT01541553), patients ≥18 years with four to eight clinically typical, visible, discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp underwent Cryosurgery followed 3 weeks later by once-daily ingenol mebutate 0.015% or vehicle gel for 3 consecutive days. Endpoints included complete clearance at week 11 and safety and efficacy over 12 months. RESULTS: In 329 randomized patients, complete clearance rates were greater with ingenol mebutate than vehicle (week 11: 60.5% vs 49.4%; P=.04; month 12: 30.5% vs 18.5%; P=.01). Fewer patients experienced the emergence of new lesions with ingenol mebutate than with vehicle (38.9% vs 51.9%; P =.02). At month 12, mean percentage reduction of AKs was higher with ingenol mebutate than with vehicle (68.2% vs 54.1%; P =.002). The probability of remaining free of lesions was sustained longer with ingenol mebutate compared with vehicle gel: 78% vs 68% at 6 months; 64% vs 57% at 9 months; 55% vs 40% at month 12, respectively. Ingenol mebutate 0.015% gel was well tolerated and no unexpected adverse events occurred; all adverse events resolved within 2 weeks of starting treatment. CONCLUSIONS: Field treatment with ingenol mebutate 0.015% gel following Cryosurgery significantly enhanced clearance of baseline lesions, and was well tolerated. Furthermore, ingenol mebutate 0.015% gel following Cryosurgery reduced development of new lesions in the treated field.
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efficacy and safety of ingenol mebutate 0 015 gel 3 weeks after Cryosurgery of actinic keratosis 11 week results
Journal of Drugs in Dermatology, 2014Co-Authors: Brian Berman, William C Hanke, Wm Philip Werschler, Kim Mark Knudsen, Torsten Skov, Joana Carla Soares Goncalves, Gary Goldenberg, Stephen K. Tyring, Thomas Larsson, Neil A SwansonAbstract:INTRODUCTION: Cryosurgery is the most common treatment for actinic keratosis (AK) in the United States. Efficacy with Cryosurgery is variable, and is a modality for treating individual, visible lesions while failing to treat subclinical lesions. METHODS: FIELD Study 1 (NCT01541553) is a phase 3, multicenter, randomized, double-blind study that evaluated the short- (11-week) and long- (12-month) term efficacy and safety of sequential AK treatment using Cryosurgery with liquid nitrogen followed by ingenol mebutate gel, versus Cryosurgery followed by vehicle. RESULTS: Overall, 329 patients were randomized to ingenol mebutate 0.015% gel (n=167) or vehicle (n=162) 3 weeks after Cryosurgery. Baseline characteristics were balanced across groups. At week 11, complete clearance rate (100%) in the treatment area was higher for ingenol mebutate gel compared with vehicle (60.5% vs 49.4%, respectively; P=.04). Mean percentage reduction in number of AKs versus baseline was also numerically higher for ingenol mebutate gel (82.7% vs 75.6%). A general reduction from baseline lesion count was observed 3 weeks after Cryosurgery. Treatment after Cryosurgery was well tolerated. CONCLUSIONS: Short-term (11-week) AK clearance rates on the face or scalp with ingenol mebutate gel after Cryosurgery were higher than with Cryosurgery alone.