A prospective, interventional, randomized, open-label, comparative, three-arm, parallel allocation, single-center clinical study to evaluate the effectiveness of Venusia CeraPlus cream and lotion as an adjuvant in the treatment of atopic dermatitis

Objectives: Atopic dermatitis (AD), often referred to as eczema, is a persistent inflammatory skin disorder that exhibits a remarkable prevalence worldwide. Adjuvant therapies, alongside prescribed treatment, have potential in effective management. The present clinical study aims to explore the safety and efficacy of two test formulations (cream and lotion) on the AD condition when used as an adjuvant alongside the prescribed treatment. Materials and Methods: A prospective, interventional, randomized, open-label, comparative, three-arm, parallel allocation clinical study was conducted on 45 participants, diagnosed with AD based on the AD severity index (ADSI) score between 2 and 8 (mild-to-moderate eczema) with two independent lesions. They were equally distributed into three arms: Arm 1 – cream with standard of care (SoC), Arm 2 – lotion with SoC, and Arm 3 – SoC alone. They were randomized to receive either of the test products with SoC or SoC alone, for 28 days, and underwent dermatological, instrumental, and subjective assessments. Results: The mean ADSI score in arm 1 was significantly reduced by 45.556% and 81.349%, and for arm 2 by 51.403% and 93.240% on day 14 and 28, respectively ( P < 0.0001). Arm 3 also exhibited a significant reduction of 32.355% and 63.946% ( P < 0.0001). After 24 h (Day 02), arms 1 and 2 demonstrated significant improvement in skin moisturization by 47.861% and 42.742%, whereas arm 3 exhibited 34.862% increase ( P < 0.0001); in contrast, the respective untreated control sites showed 0.121%, 0.848%, and 4.527% improvement in moisturization. Test sites of arms 1 and 2 showed greater improvement by 36.11% and 22.33% than arm 3. A reduction by 26.648%, 26.308%, and 21.371% for the skin barrier function for treated sites of arms 1, 2, and 3 was recorded on day 02, wherein 1.408%, 0.998%, and 1.451% change from baseline was examined in respective control sites. Clinically, the cream and lotion, when applied along with SoC, exhibited 22.39% and 23.04% greater results than the SoC alone. Both the test products were found effective in retaining/improving skin’s moisture and in reducing the severity of eczema/AD, skin itchiness, and skin redness as assessed by subjective feedback. Conclusion: The test products (cream and lotion), when used as an adjuvant, alongside the prescribed treatment, were found effective in reducing the severity of AD within 28 days, improved skin moisturization and skin barrier function within 24 h, and helped in reducing skin itching and redness, and were well tolerated.