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

Salimi, S, Fakhri, M, Saeedi, M ORCID: 0000-0003-2617-9961, Rahimnia, SM ORCID: 0000-0003-1499-7668, Kazeminejad, A ORCID: 0000-0002-3870-0382, Moosazadeh, M ORCID: 0000-0002-5452-514X, Habibi, E ORCID: 0000-0002-7367-1484 and Jokar, A ORCID: 0000-0002-0843-5151 (2025) 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. Journal of Cosmetic Dermatology, 24 (12). ISSN 1473-2130

Preview

Text J of Cosmetic Dermatology - 2025 - Salimi - The Therapeutic Effects of a Bentonite‐Based Facial Mask With Alcea sulphurea.pdf - Published Version Available under License Creative Commons Attribution. Download (549kB) | Preview

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

Item Type:	Article
Uncontrolled Keywords:	Humans; Acne Vulgaris; Bentonite; Azithromycin; Plant Extracts; Anti-Bacterial Agents; Treatment Outcome; Severity of Illness Index; Double-Blind Method; Masks; Quality of Life; Adolescent; Adult; Patient Satisfaction; Female; Male; Young Adult; Alcea sulphurea extract; acne vulgaris; add‐on randomized controlled clinical trial; bentonite; traditional Persian medicine; Humans; Acne Vulgaris; Female; Male; Adult; Severity of Illness Index; Young Adult; Patient Satisfaction; Treatment Outcome; Bentonite; Plant Extracts; Azithromycin; Adolescent; Double-Blind Method; Masks; Anti-Bacterial Agents; Quality of Life; 32 Biomedical and Clinical Sciences; 3202 Clinical Sciences; Complementary and Integrative Health; Clinical Research; Clinical Trials and Supportive Activities; 6.1 Pharmaceuticals; Humans; Acne Vulgaris; Female; Male; Adult; Severity of Illness Index; Young Adult; Patient Satisfaction; Treatment Outcome; Bentonite; Plant Extracts; Azithromycin; Adolescent; Double-Blind Method; Masks; Anti-Bacterial Agents; Quality of Life; 1103 Clinical Sciences; Dermatology & Venereal Diseases; 3202 Clinical sciences
Subjects:	R Medicine > RL Dermatology R Medicine > RM Therapeutics. Pharmacology R Medicine > RS Pharmacy and materia medica
Divisions:	Pharmacy and Biomolecular Sciences
Publisher:	Wiley
Date of acceptance:	30 October 2025
Date of first compliant Open Access:	15 January 2026
Date Deposited:	15 Jan 2026 15:39
Last Modified:	15 Jan 2026 15:39
DOI or ID number:	10.1111/jocd.70586
URI:	https://researchonline.ljmu.ac.uk/id/eprint/27921

View Item