Abstract
Background Treating dermatological pathologies under occlusion therapy is a popular adjunct, especially in thickened, lichenified areas of psoriasis where sustained contact with topical corticosteroids plays a pivotal role. Film-forming spray (FFS) can be a novel, alternate approach along with topical treatment in this area for carefully selected cases. This study aimed to evaluate the safety profile and physical characteristics of a novel formulation of an FFS in patients with psoriasis and eczema. Methods This open-label, multicentre, comparative study included subjects diagnosed with chronic plaque psoriasis requiring topical corticosteroid therapy or those with eczema necessitating its application and occlusion therapy. The study product was applied to two groups of subjects. For patients in group 1, the FFS was applied to the skin area affected by the dermatological condition, which was covered with ointment only. In the second group, the FFS was applied to the corresponding unaffected skin area. The FFS was applied for 60-90 seconds and was observed for two hours after the application. The subjects were evaluated for primary outcomes, including safety assessment, overall physical characteristics, and appearance of FFS from local skin effects. The secondary outcomes included physical appearance characteristics and overall patient satisfaction following the application of FFS at the target sites. Further statistical assessments were conducted using the SAS software version 9.4 (2023; SAS Institute Inc., Cary, North Carolina, United States). Result A total of 100 subjects were included in the study across 10 outpatient centers, of which 79% had psoriatic plaques and 21% had eczematous lesions. Primary outcomes showed a lack of appearance of clinical symptoms such as dryness, flakiness, or irritation. A total of 10% of subjects in group 1 had erythema, and 6% had a tingling sensation, which was transient and mild. The secondary outcomes showed that only 12% of subjects in Group 1 and 6% of subjects in Group 2 showed a feeling of stickiness at the application site. In group 1, 8% reported a cooling sensation, which disappeared in one and two minutes, and none experienced a cooling sensation in Group 2. The average drying time for FFS in subjects with dermatological conditions was 5.19 minutes compared to 1.51 minutes on unaffected skin. The film washability results indicated that 96% of subjects in group 1 reported complete removal in less than two minutes. At the end of the study period, the mean satisfaction score was 8.99. No significant adverse events were reported in the patients. Conclusion This study highlights the potential application of a novel formulation of FFS as a safe and well-tolerated option for enhancing uniform skin coverage with the topical corticosteroid in patients affected with psoriasis and eczema.