THE EFFICACY OF 7% ECTOINE CREAM FOR FACIAL SEBORRHEIC DERMATITIS IN THE ACUTE AND MAINTENANCE PHASES, RANDOMIZED CONTROLLED TRIAL

Abstract

This randomized controlled trial aimed to evaluate the efficacy and safety of 7% ectoine cream in the treatment of facial seborrheic dermatitis during both the acute and maintenance phases. In the acute phase, 40 patients were randomized to receive either 7% ectoine cream or 1% hydrocortisone cream for four weeks. Both 7% ectoine and 1% hydrocortisone showed a statistically significant reduction in seborrheic dermatitis area and severity index (SEDASI) from baseline at day 42 (p = 0.001 and < 0.001, respectively). Although the hydrocortisone group showed a greater reduction, the difference between the two groups was not statistically significant (p = 0.622). The rates of complete remission and clinical improvement were also not significantly difference between the two groups (p = 0.358 and p = 0.871, respectively). In the maintenance phase, 32 patients who responded to the acute treatment phase were randomized to receive either 7% ectoine cream or placebo for 12 weeks. Both were formulated to be identical in appearance. Moreover, The composition of the placebo cream was the same as 7%ectoine cream base. The ectoine group exhibited lower relapse rates at days 28, 56, and 84 (31.25%, 56.25%, 81.25% vs. 75%, 93.75%, 93.75%, respectively). Although the difference did not reach statistical significance (p = 0.065), a favorable trend was observed. The mean time to relapse was longer in the ectoine group (56 days) compared to the placebo group (28 days). Adverse events in both phases were mild, such as stinging or itching. No serious adverse effects were reported. In conclusion, 7% ectoine cream demonstrated comparable efficacy to 1% hydrocortisone cream in the acute phase and showed a trend toward reducing relapse and prolonging disease control in the maintenance phase. It can be used as a safe alternative treatment, especially for patients who prefer avoid corticosteroids.

การศึกษานี้เป็นการวิจัยเชิงทดลองแบบสุ่มมีกลุ่มควบคุม (Randomized Controlled Trial) โดยมีวัตถุประสงค์เพื่อประเมินประสิทธิผลและความปลอดภัยของครีม 7% ectoine ในการรักษาภาวะผิวหนังอักเสบซีบอเรอิคบริเวณใบหน้า ทั้งในระยะเฉียบพลันและระยะโรคสงบ ในระยะเฉียบพลัน ผู้ป่วย 40 รายถูกสุ่มให้ใช้ครีม 7% ectoine หรือ 1% hydrocortisone เป็นเวลา 4 สัปดาห์ ผลการประเมินโดยใช้ค่า seborrheic dermatitis area and severity index (SEDASI) พบว่าทั้ง7% ectoine และ 1% hydrocortisone ณ วันที่ 42 มีคะแนนลดลงจาก baseline อย่างมีนัยสำคัญทางสถิติ (p= 0.001 และ