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.

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-Ã -vis placebo, in house conventional cream of CysA and a active comparator i.e., marketed topical colbetasol propionate 0.05% w/w.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/12/002307

Enrollment

Registered

2011-12-29

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 (2.0% w/w): OD, topical for 14 weeks Intervention2: Cyclosporin A liposomal gel (2.0% w/w): OD, topical for 14 weeks Control Intervention1: Conventional

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; • 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.

Design outcomes

Primary

Measure	Time frame
Mean fall in four point Dermatological Sum Score (DSS) score from baselineTimepoint: 0, 2, 4, 6, 8, 10, 12, 14	—

Secondary

Measure	Time frame
Seven point Physicianâ??s Global Assessment (PGA) scaleTimepoint: 0, 2, 4, 8 and 14	—

Countries

India

Contacts

Public ContactDr O P Katare

Postgraduate Institute of Medical Education & Research (PGIMER)

sundogra@hotmail.com01722747610

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 2, 2026