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.

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.