Veraldi S, Barbareschi M, Guanziroli E, Bettoli V, Minghetti S, Capitanio B, Sinagra J L, Sedona P, Schianchi R
Department of Pathophysiology and Transplantation, University of Milan, I.R.C.C.S. Foundation, Cà Granda Ospedale Maggiore Policlinico, Milan, Italy -
G Ital Dermatol Venereol. 2015 Apr;150(2):143-7.
A fixed combination of 0.1% hydroxypinacolone retinoate (synthetic esther of 9-cis-retinoic acid), 1% retinol in glycospheres and 2% papain in glycospheres in aqueous gel has been recently introduced into the Italian market in order to reduce the incidence and severity of irritant contact dermatitis caused by topical retinoids, without compromising their efficacy. Primary objectives of this sponsor-free, pilot, open, multicenter study were to evaluate the efficacy and tolerability of this gel in patients with comedonal-papular, mild to moderate acne of the face.
Ninety-eight Caucasian patients (28 males and 70 females), with an age ranging from 15 to 40 years, were treated with the gel once daily for 12 weeks. Acne severity and treatment efficacy were evaluated by means of the Global Acne Grading System (GAGS) and lesions count.
Ninety-four patients were considered evaluable. A 41% mean reduction in the GAGS score was observed; a 40.8% mean reduction of total lesions was recorded; 15.3% of patients experienced mild to moderate local side effects (dryness, peeling, erythema, burning). No patients stopped the treatment because of these side effects.
This study, based on a high number of evaluable patients, demonstrates that this fixed combination is an effective and safe option for the treatment of comedonal-papular, mild to moderate acne of the face. A controlled clinical study is necessary to confirm these data.
一种含有0.1%羟基频哪酮视黄酸酯(9-顺式维甲酸的合成酯)、1%包裹于糖球体中的视黄醇和2%包裹于糖球体中的木瓜蛋白酶的水凝胶固定组合最近已进入意大利市场,旨在降低局部维甲酸类药物引起的刺激性接触性皮炎的发生率和严重程度,同时不影响其疗效。这项无赞助的、试点性的、开放性的多中心研究的主要目的是评估这种凝胶对面部粉刺丘疹型轻至中度痤疮患者的疗效和耐受性。
98名年龄在15至40岁之间的白种人患者(28名男性和70名女性),每天使用该凝胶一次,持续12周。通过全球痤疮分级系统(GAGS)和皮损计数评估痤疮严重程度和治疗效果。
94名患者被认为可评估。观察到GAGS评分平均降低41%;记录到总皮损平均减少40.8%;15.3%的患者出现轻至中度局部副作用(干燥、脱皮、红斑、烧灼感)。没有患者因这些副作用而停止治疗。
这项基于大量可评估患者的研究表明,这种固定组合是治疗面部粉刺丘疹型轻至中度痤疮的一种有效且安全的选择。需要进行对照临床研究来证实这些数据。