Zymbilan®-PSO cream with nano-encapsulated RetileX-A®-PRO mitigates the clinical severity and relieves the symptoms of chronic plaque psoriasis: an interventional clinical study

Authors

  • Jan Wadstein Department of Research and Development, Wadlund A/S, Lund, Sweden

DOI:

https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20212544

Keywords:

Zymbilan®, RetileX-A®, Psoriasis, Retinoids, Nanoencapsulation, Topical treatment

Abstract

Background: Skin psoriasis is a serious inflammatory disorder with increased risk of rheumatic, cardiometabolic and psychosocial complications. At present, >50% of patients are dissatisfied with their treatment; thus, novel approaches are in high clinical demand. Retinoids are a major group of anti-psoriatic compounds; nonetheless, dose-dependent topical side effects have limited their effective topical application. RetileX-A®-PRO (Pharma Medico, Aarhus, Denmark) is a novel nano-encapsulated retinol ester designed to minimise the risk of skin irritation. The proprietary nano-encapsulation technology used in this compound can protect retinoid molecules from degradation, and thereby prolong and stabilise its release profile. The safety and efficacy of RetileX-A®-PRO were evaluated in this study.

Methods: 45 patients (58% female, aged 18-80 years) with mild to moderate skin psoriasis were enrolled in a 4-week interventional study. Participants were treated once daily with Zymbilan®-PSO cream with RetileX-A®-PRO and evaluated both objectively and subjectively at baseline, after 8 hours and at endpoint.

Results: Our observations demonstrated that Zymbilan®-PSO cream possesses both short-term and long-term anti-psoriatic effects. Shortly after application, objective skin characteristics were improved, and itching reduced in >84% of subjects. At endpoint, 87% of skin lesions improved, 9% did not change and 4% progressed as assessed by a dermatologist. Patients’ self-evaluation yielded similar results: 78% judged Zymbilan®-PSO cream as a ‘good’ to ‘very good’ skin care product with suitable cosmetic parameters. No side effects recorded in 95% of participants.

Conclusions: In conclusion, Zymbilan®-PSO cream is a well-tolerated treatment that can mitigate both clinical severity and subjective symptoms of chronic skin psoriasis.

References

Parisi R, Symmons DP, Griffiths CE, Ashcroft DM. Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013;133(2):377-85.

Takeshita J, Grewal S, Langan SM, Mehta NN, Ogdie A, Van Voorhees AS, et al. Psoriasis and comorbid diseases: Epidemiology. J Am Acad Dermatol. 2017;76(3):377-390.

Kurd SK, Gelfand JM. The prevalence of previously diagnosed and undiagnosed psoriasis in US adults: results from NHANES 2003-2004. J Am Acad Dermatol. 2009;60(2):218-24.

Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol. 2013;149(10):1180-5.

Boehncke WH, Schön MP. Psoriasis. Lancet. 2015;386(9997):983-94.

Roos TC, Jugert FK, Merk HF, Bickers DR. Retinoid metabolism in the skin. Pharmacol Rev. 1998;50(2):315-33.

Jean J, Soucy J, Pouliot R. Effects of retinoic acid on keratinocyte proliferation and differentiation in a psoriatic skin model. Tissue Eng Part A. 2011;17(13-14):1859-68.

Orfanos CE, Pullmann H, Runne U, Kurka M, Strunk V, Künzig M et al. Treatment of psoriasis using vitamin A, vitamin A acid and oral retinoids. Hautarzt. 1979;30(3):124-33.

Date AA, Naik B, Nagarsenker MS. Novel drug delivery systems: potential in improving topical delivery of antiacne agents. Skin Pharmacol Physiol. 2006;19(1):2-16.

World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191-4.

Fry L, Macdonald A, McMinn RM. Effect of retinoic acid in psoriasis. Bri j Dermatol. 1970;83(3):391-6.

Macdonald A, Fry L. Retinoic acid in the treatment of psoriasis. Bri J Dermatol. 1972;86(5):524-7.

McMichael AJ, Griffiths CE, Talwar HS, Finkel LJ, Rafal ES, Hamilton TA et al. Concurrent application of tretinoin (retinoic acid) partially protects against corticosteroid‐induced epidermal atrophy. Bri J Dermatol. 1996;135(1):60-4.

Orienti I, Fini A, Zecchi V, Zuman P. Diffusion of naproxen in presence of beta-cyclodextrin across a silicone rubber membrane. Pharm Acta Helv. 1991;66(7):204-8.

Baek JS, Lim JH, Kang JS, Shin SC, Jung SH, Cho CW. Enhanced transdermal drug delivery of zaltoprofen using a novel formulation. Int J Pharm. 2013;453(2):358-62.

Kim BH, Lee YS, Kang KS. The mechanism of retinol-induced irritation and its application to anti-irritant development. Toxicol Lett. 2003;146(1):65-73.

Downloads

Published

2021-06-24

Issue

Section

Original Research Articles