The Therapeutic Effects of a Bentonite‐Based Facial Mask With Alcea sulphurea Extract on Acne Severity and Patient Experience: Add‐On Randomized Controlled Clinical Trial

ABSTRACT Background Acne vulgaris adversely impacts quality of life, requiring safer alternatives to conventional treatments. This study explores a facial mask combining Bentonite's detoxifying and Alcea sulphurea 's anti‐inflammatory properties, rooted in Traditional Persian Medicine (TPM). It aims to evaluate its efficacy in reducing acne severity and enhancing patient satisfaction, integrating traditional and modern therapeutic approaches. Methods This add‐on randomized, controlled clinical trial included 60 patients with moderate acne, recruited through purposive sampling in Sari from October 2022 to November 2023. Participants were randomly allocated into intervention (Bentonite‐Alcea mask + Azithromycin 250 mg) and placebo (placebo + Azithromycin 250 mg). Outcomes, including lesion count, acne severity, and satisfaction, were assessed at baseline, 4 weeks, and 8 weeks. Data analysis was conducted using SPSS version 16. Results Sixty people completed the study (30 persons in both group). The mean and standard deviation of the age in control group was 24 ± 8.03 years and in placebo group was 19.03 ± 7.03 and 46 subjects (76.7%) were female. TLC and ASI in the fourth and eighth weeks in control group were significantly less than in placebo group ( p  < 0.001). The percentage of relatively satisfied and very satisfied participants in the intervention group was significantly higher than the control group ( p  < 0.001). Bentonite‐based facial mask with Alcea sulphurea extract had no serious side effects. The intervention group exhibited significant reductions in TLC (total lesion count) (55.45% ± 21.74%) and ASI (Acne Severity Index) (66.33% ± 27.15%) from baseline to 8 weeks ( p  < 0.001), outperforming the placebo group. Patient satisfaction was notably higher in the intervention group, with 43.3% being very satisfied compared to 3.3% in the placebo group ( p  < 0.001). Conclusion A facial mask based on Bentonite and A. sulphurea extract effectively reduces acne severity and enhances patient satisfaction. These findings suggest its potential as a natural alternative or adjunct to conventional acne treatments. Trial Registration Iranian registry: IRCT20220403054395N1