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A clinical study to find out the efficacy of two newly developed formulation of Cyclosporin A

Preliminary open-label, dose-response study with phospholipid-structured vesicular and non-vesicular carrier systems of Cyclosporin A in patients with mild to moderate stable plaque psoriasis. - ODCysA

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/12/002240
Enrollment
20
Registered
2011-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Mild to moderate symmetrical stable plaque psoriasis

Interventions

Intervention1: Cyclosporin A Liposomal gel: 1.00% w/w, 1.50% w/w, 2.00% w/w, 2.50% w/w, OD, topical for 8 weeks Intervention2: Cyclosporin A: Liposomal gel Intervention3: Cyclosporin A Lecithin organo

Sponsors

UGC Center with Potential for Excellence in Biomedical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • 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 • 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.

Exclusion criteria

Exclusion criteria: • 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; • Patient 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.

Design outcomes

Primary

MeasureTime frame
Four point scale Dermatological Sum Score (DSS)Timepoint: 0, 2, 4, 6, 8

Secondary

MeasureTime frame
Seven point Physicians Global Evaluation (PGE)Timepoint: 0, 2, 4, 6, 8

Countries

India

Contacts

Public ContactDr O P Katare

Postgraduate Institute of Medical Education & Research

sundogra@hotmail.com01722747610

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026