De Padova Maria Pia, Marzani Barbara, Pinto Daniela, Rinaldi Fabio
Dermatology, Nigrisoli Private Hospital, Bologna, Italy.
R&D, Giuliani SpA, Milan, Italy.
Dermatol Ther (Heidelb). 2018 Sep;8(3):455-462. doi: 10.1007/s13555-018-0252-3. Epub 2018 Jul 27.
Actinic keratosis (AKs) are epidermal lesions that commonly occur in skin exposed to chronic cumulative UV irradiation. Untreated AK lesions can advance to squamous cell carcinoma. Current treatments of AK have many shortcomings; for instance, not all treatments can be used for the hyperkeratotic form of AK. The aim of this study was to test the efficacy and tolerability of a topical product containing 2,4,6-octatrienoic acid and urea for the treatment of hyperkeratotic AK lesions.
Forty male and female subjects with at least two hyperkeratotic AK lesions were enrolled in this single-arm, open-label phase IV study. The product was applied twice daily for two consecutive months. The efficacy endpoints were the reductions in the mean number of AK lesions per subject from baseline (T0) to the end of the trial (T1) and to three months after the end of the treatment period (T2).
At T0, the mean (SD) number of lesions per subject was 3.65 (1.25). At the end of the treatment period (T1), this number had dropped (significantly, p < 0.0001) by 83.56%. The mean number of lesions per subject then decreased by 41.47% (p < 0.0001) between T1 and the three-month follow-up visit (T2). Complete elimination of lesions had occurred in 57.5% of the subjects at T1, and 82.5% (55% who had remained completely clear of lesions since T1, and 27.5% who had fully eliminated their lesions during the period from T1 to T2) at T2. No side effects were reported.
The application of a topical combination of 2,4,6-octatrienoic acid and urea twice daily for 60 consecutive days is a safe and effective treatment for hyperkeratotic AK lesions.
Giuliani SpA.
光化性角化病（AK）是一种表皮病变，常见于长期累积紫外线照射的皮肤部位。未经治疗的AK病变可能会发展为鳞状细胞癌。目前AK的治疗方法存在许多缺点；例如，并非所有治疗方法都可用于治疗角化过度型AK。本研究的目的是测试一种含有2,4,6 - 辛三烯酸和尿素的外用产品治疗角化过度型AK病变的疗效和耐受性。
本单臂、开放标签的IV期研究纳入了至少有两处角化过度型AK病变的40名男性和女性受试者。该产品每天涂抹两次，连续使用两个月。疗效终点是每位受试者从基线（T0）到试验结束（T1）以及治疗期结束后三个月（T2）时AK病变平均数量的减少情况。
在T0时，每位受试者的病变平均（标准差）数量为3.65（1.25）。在治疗期结束时（T1），这一数字显著下降（p < 0.0001）了83.56%。然后，每位受试者的病变平均数量在T1和三个月随访期（T2）之间又下降了41.47%（p < 0.0001）。在T1时，57.5%的受试者病变完全消除，在T2时这一比例为82.5%（55%自T1起一直保持病变完全清除，27.5%在从T1到T2期间病变完全消除）。未报告有副作用。
连续60天每天两次外用2,4,6 -辛三烯酸和尿素的组合是治疗角化过度型AK病变的一种安全有效的方法。
朱利亚尼股份公司
