Topical use of the herbal formulation Ṭila-i Muhāsā (TM) is effective and well-tolerated for patients with moderate to severe acne vulgaris, according to study findings published in the Journal of Herbal Medicine.
The single-arm, interventional study included patients who were clinically diagnosed with facial acne vulgaris from Karnataka, India, from March 2019 to May 2020. TM contained Azadirachta indica A Juss leaves, Albizia lebbeck L stem bark, and Iris ensata Thunb roots.
Participants were administered finely powdered TM to apply on a washed and dried face at night after preparing a homogeneous paste in lukewarm water. After 20 to 30 minutes, they were advised to wash their face with water. The 3-week trial included 3 follow-ups, and the response to treatment was assessed with a 4-point grading scale.
A total of 30 patients (mean ± SD age, 24.5 ± 4.07 years; 80% women) were included, of whom 53.3% had oily skin, 46.7% had mixed skin type, and 40% had a positive family history for acne.
Of the cohort, 43.3% of patients had mild comedones, 36.7% had moderate comedones, and 13.3% had severe comedones. At the study’s end, 83.3% of participants reported no comedones, and 16.7% had mild comedones. The total percentage change between the pre- and post-intervention variables was 76.6%, which was statistically significant (P <.0001).
All participants had papules at baseline, of whom 70.0% had moderate papules, 16.7% had mild papules, and 13.3% had severe papules. After treatment, 86.7% of patients were free of papules, 16.7% had mild papules, and 3.3% had moderate papules. The total percentage change between the pre- and post-intervention variables was 86.7%, which was statistically significant (P <.0001).
At baseline, 73.3% patients had moderate pustules, 20.0% had mild pustules, and 6.7% had severe pustules. At the end of the trial, 80.0% patients were free of pustules, and20.0% had mild pustules. The total percentage change between the pre- and post-intervention variables was 80.0%, which was statistically significant (P <.0001).
Statistically significant improvements were also observed in nodules, itching, and erythema.
Overall disease severity was assessed with investigators’ global assessment, with mean rankings at baseline, first follow-up, second follow-up, and third follow-up of 3.82, 3.07, 2.00, and 1.12, respectively, showing a steady decrease the investigators noted.
The Cardiff Acne Disability Index (CADI) was used to assess participants’ quality of life. The mean ± SD of total data was 9.7 ± 2.5 before treatment and significantly decreased to 2.7 ± 2.6 at the end of the study (P <.0001), and 16.7% of participants reported bearable dryness.
Study limitations include the smaller sample size, noncontrolled design, and shorter duration of therapy.
“This study has provided evidence that the present formulation is safe, efficacious, and tolerable in acne patients,” the study authors commented. “Randomized controlled clinical trials with an adequate sample size should be conducted to further establish the efficacy of intervention.”
Doni M, Patel MI, Khalid M, Husain N, Khan MQ, Ayesha B. Therapeutic evaluation of herbal formulation in acne vulgaris and its influence on quality of life—a single-arm clinical trial. J Herbal Med. Published online May 28, 2022. doi.org/10.1016/j.hermed.2022.100577