CTRI Number	CTRI/2011/12/002307 [Registered on: 29/12/2011] Trial Registered Retrospectively
Last Modified On:	29/12/2011
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study	Drug
Study Design	Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study Modification(s)	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.
Scientific Title of Study	A Single Centre Randomized, Double-Blind, Short-Term, Prospective Trial for Evaluation of Efficacy and Safety of Topically Applied Novel formulation of Cyclosporin A (CysA) 2% w/w in patients with localized stable plaque psoriasis vis-à-vis placebo, in house conventional cream of CysA and a active comparator i.e., marketed topical colbetasol propionate 0.05% w/w.
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Sunil Dogra  Address  Department of Dermatology Venereology and Leprology Postgraduate Institute of Medical Education and Research PGIMER Chandigarh CHANDIGARH 160012 India  Phone  01722747610   Fax     Email  sundogra@hotmail.com
Details Contact Person Scientific Query	Name  Dr Sunil Dogra  Address  Department of Dermatology Venereology and Leprology Postgraduate Institute of Medical Education and Research PGIMER Chandigarh CHANDIGARH 160012 India  Phone  01722747610   Fax     Email  sundogra@hotmail.com
Details Contact Person Public Query	Name  Dr O P Katare  Address  University Institute of Pharmaceutical Sciences Panjab University Chandigarh CHANDIGARH 160014 India  Phone  01722534112   Fax     Email  drkatare@yahoo.com
Source of Monetary or Material Support	University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh 160014
Primary Sponsor	Name  UGC Center with Potential for Excellence in Biomedical Sciences  Address  UGC Center with Potential for Excellence in Biomedical Sciences (Pharmaceutical Extension Block) Panjab University, Chandigarh India  Type of Sponsor  Research institution
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Sunil Dogra  New OPD, Department of Dermatology, Venereology and Leprology PGIMER  Post Graduate Institute of Medical Education and Research, Sector-12, Chandigarh- 160 012 Chandigarh   01722747610 sundogra@hotmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Institute Ethics Committee of Post Graduate Institute of Medical Education and Research  Approved
Regulatory Clearance Status from DCGI	Status  Approved/Obtained
Health Condition / Problems Studied	Health Type  Condition  Patients  Mild to moderate symmetrical stable plaque psoriasis
Intervention / Comparator Agent	Type  Name  Details  Comparator Agent  Clobetasol propionate o/w cream (0.05% w/w),  OD, topical for 14 weeks   Comparator Agent  Conventional cyclosporin A o/w cream(2.0% w/w)  OD, topical for 14 weeks  Intervention  Cyclosporin A liposomal gel (2.0% w/w)  OD, topical for 14 weeks   Comparator Agent  Placebo  OD, topical for 14 weeks
Inclusion Criteria	Age From  12.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  • 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.
ExclusionCriteria	Details  • 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.
Method of Generating Random Sequence	Random Number Table
Method of Concealment	Centralized
Blinding/Masking	Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome	Outcome  TimePoints  Mean fall in four point Dermatological Sum Score (DSS) score from baseline  0, 2, 4, 6, 8, 10, 12, 14
Secondary Outcome	Outcome  TimePoints  Seven point Physician’s Global Assessment (PGA) scale  0, 2, 4, 8 and 14
Target Sample Size	Total Sample Size="34" Sample Size from India="34"
Phase of Trial	Phase 2
Date of First Enrollment (India)	02/07/2007
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	Not yet published
Brief Summary	This study is a single centric randomized, double-blind trial for evaluation of the efficacy and safety of a developed novel topical formulation of Cyclosporin A 2% w/w in patients with localized stable plaque psoriasis. Twenty patients with symmetrical plaque type psoriasis were randomized to treatment with 2% w/w CysA topical gel or vehicle / placebo gel (negative control), in a 14-week left-right (with-in patient) intra-individual comparison study. Further, in 14 patients, a pilot comparative study to evaluate the clinical efficacy of developed CysA lipogel vis-à-vis two active comparators (In house conventional cream of CysA and a marketed topical clobetasol propionate 0.5% w/w) was also carried out. Mean fall in Dermatological Sum Score (DSS) and seven points Physician’s Global Assessmentscore (PGA) were used as primary and secondary outcome measures, respectively. Safety studies on developed topical formulation were also carried out through an approved protocol. It included an assessment of systemic levels of CysA after topical application of novel formulation on a predesignated body surface area, as well as regular monitoring of patient’s vital parameters over the period of study. In the current clinical study, patients of all groups, showed a positive response to the novel topical formulations of Cyclosporin A vis-à-vis placebo at the end of treatment. CysA liposomal gel 2%w/w, however, was found to be more effective in comparison to lecithin organogel formulation of CysA at equivalent drug concentration. The results of pharmacokinetic studies, along with other safety evaluation protocols followed in the current investigations clearly indicated the excellent tolerability of the topical CysA lipogel.