A clinical trial to find out the efficacy and safety of novel topical formulation of Cyclosporin A, in comparison to placebo and marketed formulation, in patients with stable plaque psoriasis.
- Conditions
- Mild to moderate symmetrical stable plaquepsoriasis
- Registration Number
- CTRI/2011/12/002307
- Lead Sponsor
- UGC Center with Potential for Excellence in Biomedical Sciences
- Brief Summary
This study is asingle centric randomized, double-blind trial for evaluation of the efficacyand safety of a developed novel topical formulation of Cyclosporin A 2% w/w inpatients with localized stable plaque psoriasis. Twenty patients withsymmetrical plaque type psoriasis were randomized to treatment with 2% w/w CysAtopical gel or vehicle / placebo gel (negative control), in a 14-weekleft-right (with-in patient) intra-individual comparison study. Further, in 14patients, a pilot comparative study to evaluate the clinical efficacy ofdeveloped CysA lipogel vis-à -vis two active comparators (In house conventionalcream of CysA and a marketed topical clobetasol propionate 0.5% w/w) was alsocarried out. Mean fall in Dermatological Sum Score (DSS) and seven pointsPhysician’s Global Assessmentscore (PGA) were used as primary and secondaryoutcome measures, respectively. Safety studies on developed topical formulationwere also carried out through an approved protocol. It included an assessmentof systemic levels of CysA after topical application of novel formulation on apredesignated body surface area, as well as regular monitoring of patient’svital parameters over the period of study. In the current clinical study,patients of all groups, showed a positive response to the novel topicalformulations of Cyclosporin A vis-à -vis placebo at the end of treatment. CysAliposomal gel 2%w/w, however, was found to be more effective in comparison tolecithin organogel formulation of CysA at equivalent drug concentration. Theresults of pharmacokinetic studies, along with other safety evaluationprotocols followed in the current investigations clearly indicated theexcellent tolerability of the topical CysA lipogel.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 34
•Adults of both sexes, regardless of color or social class; •Age 12 or older, with good mental health; •Patients of stable plaque psoriasis with bilaterally symmetrical plaques measuring ≤ 100 cm2 of the body surface area; •Patients who is registered at the psoriasis clinic of the dermatology outpatient department; •Patients who agree to participate and sign the Informed Consent and •Patients who agree to return for follow-up visits.
•Patients with impaired kidney function, uncontrolled hypertension, past or present malignancy, infection, pregnancy and lactation, primary or secondary immunodeficiency, and known hypersensitivity to drug or its ingredients; •Patients who received any systemic, immunosuppressive or phototherapy at least 4 weeks or taken any topical antipsoriatic treatment within preceding two weeks prior to the study; •Patients who is under the treatment with drugs which have known pharmacological interaction with CysA; •Patients who also have psoriatic plaques of skin disorders caused by fungi or bacteria and who are making use of antimycotics or antibiotics and •Patients who do not agree to the terms described in the informed consent Informed Consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean fall in four point Dermatological Sum Score (DSS) score from baseline 0, 2, 4, 6, 8, 10, 12, 14
- Secondary Outcome Measures
Name Time Method Seven point Physician’s Global Assessment (PGA) scale 0, 2, 4, 8 and 14
Trial Locations
- Locations (1)
New OPD, Department of Dermatology, Venereology and Leprology PGIMER
🇮🇳Chandigarh, CHANDIGARH, India
New OPD, Department of Dermatology, Venereology and Leprology PGIMER🇮🇳Chandigarh, CHANDIGARH, IndiaDr Sunil DograPrincipal investigator01722747610sundogra@hotmail.com