Vejjabhinanta Voraphol, Muangsiri Walaisiri, Werawatganone Pornpen
Faculty of Pharmaceutical Sciences, Chulalongkorn University, 254 Payathai Road Patumwan, Bangkok, 10330, Thailand.
AAPS PharmSciTech. 2022 Apr 22;23(5):122. doi: 10.1208/s12249-022-02249-1.
This study introduces fluocinolone acetonide (FA) microemulsion in combination with ablative fractional lasering as a new effective treatment for scalp psoriasis. A pseudo-ternary phase diagram was constructed using the aqueous titration method. The suitable ratio of surfactant mixture (S):oil mixture (O):water was chosen from the microemulsion region of the diagram. FA was loaded into the selected ratio to prepare FA microemulsion. Ex vivo skin permeation study of the FA microemulsion with fractional laser assistance was performed to determine a proper ablative depth. A pilot clinical study was conducted to evaluate the efficacy of FA microemulsion and FA microemulsion combination with lasering at the optimum ablation depth. The selected microemulsion base contained (in wt%) 77% water, 20% S (Tween 80:ethanol, 2:1), 3% O (10% benzyl benzoate and 1% benzyl alcohol in bergamot oil), and 0.2% sodium carboxymethylcellulose. FA was loaded into this base at a concentration of 0.1%. The skin lasered at an ablation depth of 50 µm was conducted in the pilot clinical study. Scalp psoriasis responded well to the FA microemulsion. Psoriasis scalp severity index (PSSI) scores indicated that the FA microemulsion plus laser treatment provides higher efficacy than the FA microemulsion alone without any topical and systemic side effects. The efficacy of the treatments could be maintained for at least 1 week after treatment discontinuation. FA microemulsion was properly formulated and evaluated. The microemulsion demonstrating the greatest benefits was used in combination with ablative fractional lasering to treat scalp psoriasis.
本研究引入醋酸氟轻松(FA)微乳联合剥脱性点阵激光作为头皮银屑病的一种新的有效治疗方法。采用水相滴定法构建了伪三元相图。从相图的微乳区域中选择合适的表面活性剂混合物(S):油相混合物(O):水的比例。将FA载入选定比例中制备FA微乳。进行了FA微乳在点阵激光辅助下的离体皮肤渗透研究,以确定合适的剥脱深度。开展了一项初步临床研究,以评估FA微乳以及FA微乳与在最佳剥脱深度下的激光联合治疗的疗效。所选的微乳基质包含(重量百分比)77%的水、20%的S(吐温80:乙醇,2:1)、3%的O(佛手柑油中10%的苯甲酸苄酯和1%的苯甲醇)以及0.2%的羧甲基纤维素钠。FA以0.1%的浓度载入该基质中。在初步临床研究中对剥脱深度为50 µm的皮肤进行了激光治疗。头皮银屑病对FA微乳反应良好。银屑病头皮严重程度指数(PSSI)评分表明,FA微乳加激光治疗比单独使用FA微乳具有更高的疗效,且无任何局部和全身副作用。治疗停止后,疗效可维持至少1周。FA微乳得到了合理的配制和评估。将显示出最大益处的微乳与剥脱性点阵激光联合用于治疗头皮银屑病。