Niosomal methotrexate gel in the treatment of localized psoriasis: phase I and phase II studies.

نویسندگان

  • P K Lakshmi
  • Gayathri S Devi
  • Shyamala Bhaskaran
  • S Sacchidanand
چکیده

BACKGROUND Efficacy of topical methotrexate in psoriasis is limited by its penetration. AIMS The study involved the preparation of niosomal methotrexate in chitosan gel and to test the same for irritation and sensitization on healthy human volunteers followed by assessing the efficacy of the gel through double-blind placebo-controlled study on psoriasis patients and also comparing its efficacy with a marketed methotrexate gel. METHODS The methotrexate niosomes were prepared by lipid layer hydration method. The characterized niosomes were incorporated in chitosan gel. The gels were tested on 10 human volunteers to check for irritation and skin sensitivity by human repeated insult patch test (HRIPT). The formulations were assessed for efficacy by double-blind placebo-controlled study in 10 psoriasis patients for each formulation. The efficacy was calculated by psoriasis area and severity index scoring method. The global score was used to assess the progress of the disease. RESULTS The HRIPT test did not produce any significant irritation or sensitization on healthy human volunteers. The placebo and marketed gels were compared with niosomal methotrexate gel. At Week 12, with niosomal methotrexate gel, there was reduction in total score from 6.2378+/-1.4857 to 2.0023+/-0.1371. CONCLUSION These results suggest that niosomal methotrexate gel is more efficacious than placebo and marketed methotrexate gel.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

3 . 3 . Review of work done on Methotrexate

Modi Chetna D. 83 Ph. D. Thesis 3.3. Review of work done on Methotrexate Laxmi et al. 52 showed the preparation of niosomal MTX in chitosan gel and test the same of irritation and sensitization on healthy human volunteers and also comparing its efficacy with a marketed MTX gel in the treatment of localized psoriasis. Results showed that no significant irritation and sensitization is produced fr...

متن کامل

Exploring the potential of complex-vesicle based niosomal ocular system loaded with azithromycin: Development of in situ gel and ex vivo characterization

Abstract Bacterial conjunctivitis characterized as pink eye referred as an inflammation of an eye caused by the enlargement of blood vessels present in conjunctiva, resulting in a red or bloodshot appearance of the eyes. Topical ocular delivery is found to be useful in treating conjunctivitis, but to maintain an effective drug concentration at a site of action in order to achieve desired pha...

متن کامل

Comparison of bath PUVA and Acitretin in treatment of Psoriatic patients

Background: Psoriasis treatment is very important regard to mental sequeler and creating morbidity. First line treatment of generalized plaque type psoriasis includes methotrexate, phototherapy and retinoids. Objective: To compare bath-PUVA and acitretin in the treatment of generalized plaque type psoriasis. Patients and Methods: 40 patients with generalized plaque type psoriasis with PAS...

متن کامل

Does Short-Term Low-Dose Methotrexate Treatment Affect Homocysteine Blood Level in Patients with Psoriasis?

Background: An elevated homocysteine level is an independent risk factor for cardiovascular disorders. Psoriatic patients have an increased risk of cardiovascular diseases; In addition, hyperhomocysteinemia is a complication of methotrexate treatment. We undertook a study to evaluate the plasma levels of homocysteine, vitamin B12 and folate in patients with psoriasis before and after short-term...

متن کامل

Psoriasis: History, Present and Future Prospects

Psoriasis is a chronic condition which causes the inflammation of the skin due to the activation of immune system leading to abnormal keratinocytes proliferation. The keratinocytes mature within a week as compared to normal cycle of 27 to 28 days. The oldest of the treatment includes the use of coal tar, Dithranol, sunlight, Dead Sea salts and emollients. Dermatologists now have a host of new t...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • Indian journal of dermatology, venereology and leprology

دوره 73 3  شماره 

صفحات  -

تاریخ انتشار 2007