Efficacy of Novel Topical Liposomal Formulation of Cyclosporine in Mild to Moderate Stable Plaque Psoriasis

Prerana Patel, Mercer University College of Pharmacy

 

The American Academy of Dermatology (AAD) psoriasis guidelines state that approximately 80% of those effected with psoriasis have mild to moderate disease.  It is also noted that for most of these patients, topical agents can be used to help provide lesion clearance in a safe and efficacious manner.  Topical agents as monotherapy are not recommended in those with extensive disease. [1]

Title: Efficacy of Novel Topical Liposomal Formulation of Cyclosporine (CysA)  in Mild to Moderate Stable Plaque Psoriasis [2]
Design A double-blind, single-center, randomized clinical trial; N = 38
Objective To evaluate the efficacy of topical cyclosporine using liposomal nanocarriers (lipogel) in limited chronic plaque psoriasis
Study Groups Cyclosporin lipogel or placebo (n = 24), cyclosporine lipogel or conventional cylosporine cream (n = 7), cyclosporine lipogel or standard clobetasol propionate cream (n = 7)
Methods Patients were examined twice weekly for 14 weeks, or until total lesional clearance was observed, whichever was earlier.
Duration Fourteen weeks
Primary Outcome Measure Dermatological sum score (DSS) assessing erythema, scaling, and plaque
Baseline Characteristics   Arm 1 Cyclosporin Lipofel 2.0% (w/w) and Placebo Lipogel

(n = 24)

Arm 2

Cyclosporine Lipogel 2.0% (w/w) and Conventional o/w Cream of Cyclosporine 2.0% (w/w)

(n = 7)

Arm 3 Cyclosporine Lipogel 2.0% (w/w) and Clobetasol Propionate Cream 0.05% (w/w)

(n = 7)

Age, mean (SD),y 37 (14) 35 (8) 40 (13)
Men, No. 16 2 5
Women, No. 8 5 2
Psoriatic sites, No. 48 14 14
Disease duration, mean (SD), y 4.39 (2.26) 7.2 (5.3) 5.7 (3.1)
Lesion area, mean (SD), cm2 93.56 (5.67) 88.72 (6.82) 94.23 (5.42)
Mean (SD) body surface area involved (%) 8.94 (2.3) 7.2 (2.1) 5.7 (3.1)
Results   Measured by DSS
  Week 0 Week 14
Arm 1
DSS in CysA lipogel 2.0% 8.3 0.25
DSS in placebo lipogel 2.0% 8.3 6
Arm 2
DSS in CysA lipogel 2.0% 8.8 0.5
DSS in conventional cream 8.2 7.9
Arm 3
DSS in CysA lipogel 2.0% 9 8.5
DSS in Clobetasol Propionate cream 8.5 0
Adverse Events Common Adverse Events: erythema, irritation, and dryness (8.8%); fissuring (2.6%)
Serious Adverse Events: N/A
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions Topical liposomal formulation of cyclosporine, 2.0% weight-by-weight (w/w), is effective in treatment of limited chronic plaque psoriasis with a satisfactory safety profile. Future clinical trials should assess liposomal cyclosporine in larger study populations.

While the AAD does not recommend the use of topical agents alone in the treatment of serve psoriasis, the study focused on topical treatment by using a more lipophilic vehicle to deliver the drug.  Unlike other studies that only look at the number of lesions, this study took into consideration erythema, scaling, and plaque when looking at outcomes.  Knowing how cyclosporine lipogel compare to other treatments can help healthcare providers better treat patients who present with psoriasis.

 

References

[1] American Academy of Dermatology. Psoriasis: General principles Section 3 guidelines. Available at: https://www.aad.org/practice-tools/quality-care/clinical-guidelines/psoriasis/topical-therapy. Accessed April 21, 2016.

 

[2] Kumar R, Dogra S, Amarji B, et al. Efficacy of Novel Topical Liposomal Formulation of Cyclosporine in Mild to Moderate Stable Plaque Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2016

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