Formulation and Clinical Evaluation Of Ultradeformable Liposomes in the Topical Treatment of Psoriasis

Abstract

Ultradeformable liposomes of Methotrexate (MTX) were formulated to enhance its transdermal delivery in the treatment of psoriasis. Formulations were characterized for particle size, polydispersity index, morphology employing TEM and residual solvent analysis. The efficacy of topical liposomal MTX gel was compared with the commercially available plain MTX gel by clinically investigating the reduction in PASI score in psoriasis patients. Allergic contact sensitization potential of placebo ultradeformable liposomal gel was evaluated which showed that the placebo gel did not produce any reaction in the induction as well as challenge phase in 12 human volunteers. Open label, randomized parallel study was conducted in 25 patients. Baseline PASI score in the group receiving liposomal gel (0.25%) was 5.3 ± 1.027 and at the 10th week was reduced to 2.4 ± 0.625. In the case of the group applying plain MTX gel (1%), the baseline PASI score was 6.2 ± 0.17, reduced to 2.9 ± 0.79 at the 10th week. It was observed that liposomal MTX gel of 0.25% improved palmoplantar psoriasis in comparison with 1% plain MTX gel. Therefore, reducing the dose by entrapping MTX in liposomes improved the efficacy and patient compliance.

Key words: :

• Ultradeformable Liposomes
• Methotrexate
• Psoriasis
• PASI

Notes

19 Standard Operating Procedures, Clinical Trials 930.00, Repeat Insult Patch Test (RIPT). Based on the method published in Appraisal of the Safety of Chemicals, Drugs and Cosmetics - Association for Food and Drug Officials USA