| CTRI Number |
CTRI/2025/11/096810 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomised study to find which is more effective for palmoplantar psoriasis: emollients with topical steroids or emollients with oral appremilast |
|
Scientific Title of Study
|
Effectiveness of emollients with topical steroids vs emollients with oral apremilast in the management of palmoplantar psoriasis- A Randomised Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K V Pushpanjali |
| Designation |
1st year PG(Department of Dermatology, Venereology And Leprosy) |
| Affiliation |
Chettinad Hospital And Research Institute |
| Address |
Chettinad Hospital And Research Institute, Chettinad Health City,Rajiv Gandhi Salai, (OMR, Chennai), Kelambakkam-603103,Kancheepuram District.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
04447428101 |
| Fax |
|
| Email |
kv.pushpanjali1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopalakrishnan K |
| Designation |
Professor and HOD |
| Affiliation |
Chettinad Hospital And Research Institute |
| Address |
Chettinad Hospital And Research Institute, Chettinad Health City,Rajiv Gandhi Salai, (OMR, Chennai), Kelambakkam-603103,Kancheepuram district.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
04447428101 |
| Fax |
|
| Email |
dermdrgopalakrishnan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopalakrishnan K |
| Designation |
Professor and HOD |
| Affiliation |
Chettinad Hospital And Research Institute |
| Address |
Chettinad Hospital And Research Institute, Chettinad Health City,Rajiv Gandhi Salai, (OMR, Chennai), Kelambakkam-603103,Kancheepuram district.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
04447428101 |
| Fax |
|
| Email |
dermdrgopalakrishnan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital And Research Institute, Chettinad Health City,Rajiv Gandhi Salai, (OMR, Chennai), Kelambakkam-603103,Chennai. |
|
|
Primary Sponsor
|
| Name |
Dr K V Pushpanjali |
| Address |
1st floor, E107 E block Urbanrise Revolution One, OMR Main Road, Padue village, Chennai, Chennai-603103 |
| Type of Sponsor |
Other [Self] |
|
|
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 K V Pushpanjali |
Chettinad Hospital And Research Institute |
Department of Dermatology, Venereology and Leprosy, OP no.18, Chettinad Health City, Rajiv Gandhi Salai(OMR, Chennai), Kelambakkam, Tamilnadu-603103, India
Chennai
TAMIL NADU |
04447428101
hod.dermatology@care.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chettinad Academy Of Research and Education , Institutional Human Ethics Commitee For Students Research (CARE IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L408||Other psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Emollient with topical steroids
(0.1% mometasone furoate with 3% salicylic acid cream. |
Participants will apply the emollients over the entire affected area twice daily throughout the study and topical steroids(0.1% mometsone furoate with 3% salicylic acid ) over affected areas once daily and followed for every 2 weeks for 2 months |
| Comparator Agent |
Emollients with oral appremilast (30mg) |
Participants will receive standard titration of apremilast to 30mg BID for 2months.
Emollient application will be continued twice daily throughout the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 65 years.
2. Diagnosed with palmoplantar psoriasis (with or without nail involvement).
3. DLQI score greater than or equal to 5.
4. Patients who provide written informed consent
|
|
| ExclusionCriteria |
| Details |
Patients with generalised Psoriasis or psoriatic arthritis.
Pregnant or lactating women.
Patients with liver or kidney dysfunction, active tuberculosis or immunosuppressive conditions
Recent use (within 4 weeks) of systemic anti-Psoriatic drugs or biologics
Hypersensitivity to apremilast or corticosteroids |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of topical emollients with topical steroids versus emollients with oral apremilast in adults suffering from palmoplantar psoriasis |
Day 0
Wk 4
Wk 8
Wk 12
Wk 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/11/2025 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Background:
Palmoplantar psoriasis significantly impairs patient quality of life due to its location and symptoms. While topical steroids remain the standard first line treatment, they often provide inadequate long term control. Apremilast, as a systemic, non biologic agent with a favourable safety profile, presents a promising alternative. This study will provide much needed comparative data on two practical therapeutic options in a real world Indian setting, guiding clinicals towards evidence based management of palmoplantar psoriasis.
Purpose:
To compare the clinical efficacy of emollients with topical steroids versus emollients with oral Apremilast in the management of palmoplantar psoriasis.
To assess patient-reported improvement in quality of life using DLQI.
To assess the recurrence rate post treatment |