In Vitro and Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy and Safety of Nine Antiacne Medicinal Plants

Omar Said; Iyad Khamaysi; Abdalsalam Kmail; Stephen Fulder; Basheer AboFarekh; Riyad Amin; Jamila Daraghmeh; Bashar Saad

doi:10.1155/2020/3231413

In Vitro and Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy and Safety of Nine Antiacne Medicinal Plants

Evid Based Complement Alternat Med. 2020 Jul 9:2020:3231413. doi: 10.1155/2020/3231413. eCollection 2020.

Authors

Omar Said¹, Iyad Khamaysi², Abdalsalam Kmail³, Stephen Fulder¹, Basheer AboFarekh⁴, Riyad Amin¹, Jamila Daraghmeh³, Bashar Saad^{3

4}

Affiliations

¹ Independent Researcher, Beleaf Pharma, P.O. Box 2205, Kfar Kana, Galilee 16930, Israel.
² Faculty of Medicine, Technion-ITT, Rambam Medical Center, Haifa, Israel.
³ Faculty of Arts and Sciences, Arab American University Jenin, P.O. Box 240, Jenin, State of Palestine.
⁴ Qasemi Research Center-Al-Qasemi Academy, P.O. Box 124, Baqa El-Gharbia 30100, Israel.

Abstract

The present in vitro and randomized, double-blind, placebo-controlled trial aims to determine the efficacy and safety of nine Mediterranean antiacne medicinal plants. The antimicrobial, antisebum, and anti-inflammatory activities of the plant extracts were evaluated in cells from the immortalized human keratinocytes (HaCaT) and human monocytic cell line (THP-1) as well as in a double-blind, randomized, and placebo-controlled trial. Most of the extracts showed no significant cytotoxic effects on HaCaT cells up to 250 μg/ml. Inula helenium (IH) and Saponaria officinalis (SO) inhibited sebum production at 90 μg/ml and 30 μg/ml, respectively. The inhibition effect of SO on the growth of Cutibacterium acnes was 1.2 times higher than that of chloramphenicol. IH and SO extracts significantly inhibited the lipopolysaccharide- (LPS-) induced IL-6 and TNF-α production in THP-1 cells reaching the control levels of untreated cells at a concentration of 250 μg/ml. SO, IH, and Solanum nigrum (SN) extracts inhibited the nitric oxide (NO) production in a dose-dependent manner. Based on these results, an antiacne herbal cream (AHC) was prepared from different portions of extracts from SO, IH, and SN, and its efficacy was evaluated in a double-blind, randomized, and controlled efficacy study with 41 acne patients, ages 18-24, who were asked to apply AHC (n = 27) or a placebo (n = 14) two to three times daily for six weeks. Results obtained indicate that the AHC has unique synergistic effects that halt sebum production, combined with highly antiseptic and anti-inflammatory activity, in which 54.95% (t = 19.37 P < 0.001) of acne inflammatory and noninflammatory lesions disappeared after two weeks, 85.3%, after five weeks (t = 14.19 P < 0.001), and 91.4%, at the end of the sixth week of application (t = 5.7 P < 0.001). In conclusion, SO, IH, and SN as single extracts and in combination as AHC showed significant antimicrobial, antisebum, and anti-inflammatory activities in vitro and in a double-blind, randomized, and controlled antiacne efficacy. Therefore, AHC represents an interesting alternative treatment for acne.