| CTRI Number |
CTRI/2025/07/090140 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness and safety of topical cyclosporine in patients with psoriasis |
|
Scientific Title of Study
|
Pharmacokinetic and pharmacodynamic evaluation of topical liposomal formulation of cyclosporine in patients with chronic plaque psoriasis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarzoo |
| Designation |
Research Scholar |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
4040, Department of Pharmacology, Research Block B, PGIMER, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9478966723 |
| Fax |
|
| Email |
aarzoo.charaya22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Kakkar |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
4016, Department of Pharmacology, Research Block B, Sector 12, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9868051003 |
| Fax |
|
| Email |
drashishkakkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Kakkar |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
4016, Department of Pharmacology, Research Block B, Sector 12, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9868051003 |
| Fax |
|
| Email |
drashishkakkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Sector 12,
Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
4016, Department of Pharmacology, Research Block B, PGIMER, Sector 12, Chandigarh, India, 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish Kakkar |
Post Graduate Institute of Medical Education and Research |
4040, Department of Pharmacology Research Block B,
PGIMER
Chandigarh
CHANDIGARH |
9868051003
drashishkakkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coaltar |
5% concentration, once daily, topical for 12 weeks |
| Intervention |
Topical Cyclosporine formulation |
2% concentration, once daily, topical for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged 18 years or older
2. Fulfilling the criteria of stable plaque psoriasis with bilaterally symmetrical plaques measuring less than equal to 100 cm sq of the body surface area with the PASI score less than equal to 10.
3. Both male and female patients willing to use appropriate method of contraception as per investigator’s discretion throughout the study.
4. Willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
1. Impaired kidney function
2. Uncontrolled hypertension
3. Past or present malignancy
4. Current infection
5. Female patient who is breastfeeding, pregnant, or who is planning a pregnancy during the study.
6. Patient has evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis
7. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
8. Concomitant immunosuppressive therapy.
9. Primary or secondary immunodeficiency
10. Known hypersensitivity to drug or its ingredients.
12. Subject has had a major surgery within 8 weeks prior to baseline (Day 0) or has a surgery planned during the study.
13. Subject has any clinically significant medical condition or physical/laboratory abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
14. Receiving drugs which have known pharmacological interactions with cyclosporine
15. Known alcohol or drug abuse in the last 6 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in PASI score from baseline to 12 weeks |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean percentage change in PASI score
|
2 weeks, 4 weeks, 8 weeks and 12 weeks |
| Proportion of patients achieving PASI 75 |
12 weeks |
| Change in Physician Global Assessment |
12 weeks |
| Change in the Dermatology Life Quality Index |
12 weeks |
| Safety Assessments |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open label randomized parallel group trial for Evaluation of safety and efficacy of topical formulation of cyclosporine in patients with chronic plaque psoriasis that will be conducted in the Department of Dermatology and Pharmacology, PGIMER, Chandigarh. |