Engin Burhan, Güler Özden Müge, Karstarlı Bakay Özge Sevil, Kartal Selda Pelin, Zindancı İlkin, Çınar Salih Levent, Dursun Recep, Pehlivan Ulutaş Gizem, Özkök Akbulut Tuğba Özkök, Hapa Fatma Aslı, Bülbül Başkan Emel, Melikoğlu Mehmet, Polat Ekinci Algün, Demirel Öğüt Neslihan, Hızlı Pelin, Türkoğlu Zafer, Küçük Özlem Su, Topkarcı Zeynep, Türsen Ümit, Canpolat Filiz, Uçgun Hanife, Yaşar Şirin, Temiz Selami Aykut, Doğramacı Asena Çiğdem, Altuğ Sedat, Kozlu Serhat, Ulu Nadir, Serdaroğlu Server
Cerrahpaşa Faculty of Medicine, İstanbul University-Cerrahpaşa, Istanbul, Türkiye.
Faculty of Medicine, Ondokuz Mayıs University, Samsun, Türkiye.
Dermatol Ther (Heidelb). 2024 Dec;14(12):3337-3350. doi: 10.1007/s13555-024-01301-1. Epub 2024 Nov 22.
Topical therapies are used in almost all patients with psoriasis. A novel fixed topical combination cream (GN-037) with a lower concentration (0.0356%) of clobetasol 17-propionate (CP) was developed together with urea, salicylic acid, and retinoic acid to provide a better benefit-risk ratio. The present multicenter randomized double-blind vehicle-controlled parallel group phase 2 study aimed to investigate the efficacy and safety of GN-037 in patients with mild-to-moderate plaque psoriasis (MMPP).
Patients (n = 190) were randomized (2:2:1) to receive GN-037 or CP or vehicle (V) cream twice daily to a selected target body lesion for 4 weeks. The primary endpoint was treatment success defined as percentage of patients with at least two-grade improvement in Investigator's Global Assessment Score (IGA) and IGA score equal to 0 or 1 evaluated at weeks 2, 4, 6, and 8 in each arm compared with baseline. Treatment-emergent adverse events (TEAEs) and safety were evaluated throughout the study.
GN-037 demonstrated statistically significant superiority over V throughout the study. At week 4, treatment success was achieved in 37.9% of patients in the GN-037 arm compared with 29.2% and 9.1% in the CP and V arms, respectively. At least two-grade improvement compared with baseline was achieved by 57.6%, 72.7%, and 80.3% of the patients in the GN-037 arm for erythema, plaque elevation, and scaling, respectively. The mean changes in affected BSA were -2.1 ± 2.9, -1.8 ± 2.4, and -0.5 ± 1.6 in the GN-037, CP, and V arms, respectively. The TEAEs were similar among the arms and the most frequently observed TEAEs were Psoriasis Area and Severity Index (PASI) increase in all arms.
GN-037 was more effective than V in achieving primary and all secondary endpoints throughout the study. Safety data did not reveal any new safety concerns with the combination cream product. Therefore, 4 weeks of GN-037 treatment demonstrated an excellent efficacy and safety profile in patients with MMPP.
ClinicalTrials.gov identifier, NCT05706870.
几乎所有银屑病患者都会使用局部治疗方法。一种新型的固定局部复方乳膏（GN-037）被研发出来，它含有较低浓度（0.0356%）的丙酸氯倍他索（CP），并与尿素、水杨酸和维甲酸混合，以提供更好的效益风险比。本多中心随机双盲赋形剂对照平行组2期研究旨在调查GN-037治疗轻度至中度斑块状银屑病（MMPP）患者的疗效和安全性。
190名患者被随机分组（2:2:1），分别接受GN-037或CP或赋形剂（V）乳膏，每天两次涂抹于选定的目标身体皮损部位，持续4周。主要终点是治疗成功，定义为在第2、4、6和8周时，与基线相比，各治疗组中研究者整体评估评分（IGA）至少改善两级且IGA评分为0或1的患者百分比。在整个研究过程中评估治疗中出现的不良事件（TEAE）和安全性。
在整个研究过程中，GN-037在统计学上显示出优于赋形剂的效果。在第4周时，GN-037治疗组中37.9%的患者治疗成功，而CP治疗组和赋形剂治疗组分别为29.2%和9.1%。与基线相比，GN-037治疗组中分别有57.6%、72.7%和80.3%的患者在红斑、斑块隆起和鳞屑方面至少改善两级。GN-037、CP和赋形剂治疗组中受累体表面积的平均变化分别为-2.1±2.9、-1.8±2.4和-0.5±1.6。各治疗组的TEAE相似，所有治疗组中最常观察到的TEAE是银屑病面积和严重程度指数（PASI）增加。
在整个研究过程中，GN-037在实现主要和所有次要终点方面比赋形剂更有效。安全性数据未显示该复方乳膏产品有任何新的安全问题。因此，4周的GN-037治疗在MMPP患者中显示出优异的疗效和安全性。
ClinicalTrials.gov标识符，NCT05706870。
