DOI: http://dx.doi.org/10.18203/issn.2455-4529.IntJResDermatol20212544

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

Jan Wadstein

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.


Keywords


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

Full Text:

PDF

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.