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In Vivo Skin Penetration, Radical Protection, and Structural Changes After Topical Application of a Herbal Oil Cream Compared to Topical Calcipotriol in Mild to Moderate Psoriasis Publisher Pubmed



Lademann J1 ; Mansouri P2 ; Nahavandi A3 ; Ahlers A3 ; Zibakalammofrad F3 ; Brower B3 ; Nahavandi M3 ; Feddern F3 ; Darvin ME1 ; Schanzer S1 ; Richter H1 ; Meinke MC1 ; Rezaii SA4 ; Rohaninasab M2 Show All Authors
Authors
  1. Lademann J1
  2. Mansouri P2
  3. Nahavandi A3
  4. Ahlers A3
  5. Zibakalammofrad F3
  6. Brower B3
  7. Nahavandi M3
  8. Feddern F3
  9. Darvin ME1
  10. Schanzer S1
  11. Richter H1
  12. Meinke MC1
  13. Rezaii SA4
  14. Rohaninasab M2
  15. Farshi S2
  16. Iacobelli M5
  17. Jung S1
Show Affiliations
Authors Affiliations
  1. 1. Department of Dermatology, Venerology and Allergology, Charite, Universitatsmedizin Berlin, Corporate Member of Freie Universitat Berlin, Humboldt-Universitat zu Berlin, Berlin Institute of Health, Berlin, Germany
  2. 2. Tehran University of Medical Science, TUMS, Skin and Stem Cell Research Center, Tehran, Iran
  3. 3. Alnapharm AG and Co. KG, Hamburg, Germany
  4. 4. Tehran University of Medical Science, TUMS, Research Management Office, Tehran, Iran
  5. 5. Techitra Srl, Milan, Italy

Source: Skin Pharmacology and Physiology Published:2021


Abstract

Background: The chronicity of psoriasis often requires continuous topical treatment. Materials and Methods: Here, the radical protection of a cream containing various herbal oils was evaluated in vivo by electron paramagnetic resonance (EPR) spectroscopy and its skin penetration by Raman microscopy in intact and barrier-disturbed skin. Changes in skin barrier properties were evaluated after 4 weeks of daily topical application using in vivo laser scanning microscopy (LSM) and transepidermal water loss in 26 healthy volunteers. A randomized, controlled, double-blind, three-arm parallel clinical study evaluated the efficacy of the herbal oil cream compared to a 0.05% calcipotriol-containing cream and to a vehicle cream, in 135 patients with mild to moderate plaque psoriasis with the change in Psoriasis Area and Severity Index (PASI) from baseline to week 12 as the primary endpoint. Results: EPR spectroscopy disclosed a significantly higher radical formation in untreated than skin treated with the herbal oil cream (p ≤ 0.05). LSM measurements indicated a protective skin barrier effect in treated compared to untreated skin. In the clinical trial, the topical application of herbal oils showed a significant reduction of the PASI score compared to topical calcipotriol at week 12 (p = 0.016). The mean reduction in PASI was 49% for the herbal oil cream, 38% for calcipotriol, and 55% for the vehicle cream. The percentage of patients, who reached PASI 50 and 75 at any time point, was 55.9% and 29.4% for the herbal oil cream, 47.4% and 15.8% for calcipotriol, and 23 (60.5%) and 13 (34.2%) for the vehicle, respectively (p > 0.05). The vehicle, originally designed as a placebo, contained a main ingredient of the herbal oil cream and therefore showed corresponding results. Conclusion: The herbal oil cream demonstrated effectiveness in the treatment of mild to moderate plaque psoriasis. © 2021 S. Karger AG. All rights reserved.