| CTRI Number |
CTRI/2026/03/106289 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study in patients with plaque psoriasis to compare Roflumilast cream and Calcipotriol cream for improving skin symptoms and evaluating safety. |
|
Scientific Title of Study
|
A Prospective, Randomized, Parallel group, Double-blind, Active-Controlled, Multi-centric, Two-arms, Phase III Study to Assess the Efficacy and Safety of Roflumilast 0.3% w/w cream Versus Calcipotriol 50 mcg cream in patients with Plaque Psoriasis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VRL-CT-25-002, Version 3.0 dated 29-Dec-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avinash Andhale |
| Designation |
Trial Coordinator |
| Affiliation |
Vivotech Research Private Limited |
| Address |
Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
Thane
MAHARASHTRA
400703
India |
| Phone |
9987598349 |
| Fax |
|
| Email |
pi@vivotechresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash Andhale |
| Designation |
Trial Coordinator |
| Affiliation |
Vivotech Research Private Limited |
| Address |
Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
MAHARASHTRA
400703
India |
| Phone |
9987598349 |
| Fax |
|
| Email |
pi@vivotechresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamlesh Londhe |
| Designation |
Director |
| Affiliation |
Vivotech Research Private Limited |
| Address |
Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
Thane
MAHARASHTRA
400703
India |
| Phone |
7738530479 |
| Fax |
|
| Email |
kamlesh@vivotechresearch.com |
|
Source of Monetary or Material Support
Modification(s)
|
| M/s. PURE & CURE Healthcare Pvt. Ltd. |
|
Primary Sponsor
Modification(s)
|
| Name |
Ms PURE CURE HEALTHCARE PVT LTD |
| Address |
305, Mohan Place, L.S.C Block-C, Saraswati Vihar, New Delhi, (India) - 110034 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Ms PURE CURE HEALTHCARE PVT LTD |
Plot no. 131 to 133, Block –C, Mangolpuri Ind. Area, Phase – 1 (adjoining CBSE office), Delhi – 110083, India. |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Urvi Panchal |
Aarvy Healthcare and Super Speciality Hospital, |
Aarvy Healthcare and Super Speciality Hospital, Sector 90, Gurugram, Haryana 122505
Gurgaon
HARYANA |
8800827110
drurvi77@gmail.com |
| Dr Shilpa Dastikop |
Belagavi Institute of Medical Sciences, |
Belagavi Institute of Medical Sciences, Dr. B. R. Ambedkar Road Belagavi - 590010, Karnataka, India
Belgaum
KARNATAKA |
9448123723
dastikopshilpa@gmail.com |
| Dr Varsha Verma |
Criticare Hospital Research Institute |
4th Floor, Dhanashree Complex, Near Hotel Haedeo, Sitabuldi, Nagpur- 440010
Nagpur
MAHARASHTRA |
9309174666
varshaverma62@yahoo.co.in |
| Dr Vyas Harshita Ravindra |
GCS Medical College, Hospital & Research Centre |
GCS Medical College Hospital and Research Centre, Opp DRM office, Nr. Chamunda bridge, Naroda Road, Ahmedabad - 380025, Gujarat
Ahmadabad
GUJARAT |
7966048000
harshitavyas.derma@gmail.com |
| Dr Rajkumar Kothiwala |
Jawahar Lal Nehru Medical College |
Dept of Dermatology, Kala Bagh, Ajmer 305001, Rajasthan
Ajmer
RAJASTHAN |
9414118811
drrkkothiwala@gmail.com |
| Dr Ghanshyam Mukund Vinod |
Jupiter Hospital and Research Centre |
Dept of Dermatology, Jupiter Hospital and Research Centre, Opposite ICAI Bhavan, Sun Pharma - Atladara Rd, Vadodara, Gujarat 390012
Vadodara
GUJARAT |
9824488194
dr.ghanshyam.vinodnm@gmail.com |
| Dr Chanabasappa Mendagudli |
Karanataka Medical College and Resarch Institute |
Department of Dematology, OPD Block, Karanataka Medical College and Research Institute, Old PB Road, Vidyanagar, Hubbali, Karnataka - 580022, India
Uttara Kannada
KARNATAKA |
8362373348
drchanabasappamendagudli@gmail.com |
| Dr Amarjeet Singh Verma |
LLRM, Medical College |
LLRM, Medical College Garh Road, Meerut, Uttar Pradesh- 250004, India
Meerut
UTTAR PRADESH |
8107057170
amarjeetverma.av@gmail.com |
| Dr Shylaja Someshwar |
MGM Medical College & Hospital |
Dept of Dermatology & VL, MGMIHS, Kamothe, Navi Mumbai- 410209
Mumbai (Suburban)
MAHARASHTRA |
9820500964
shaila38@yahoo.co.in |
| Dr Raghavendra KR |
Mysore Medical College and Research Institute |
Dept of Clinical Research, KR Hospital, Irwin Road, Mysore - 570001
Mysore
KARNATAKA |
9633254370
drraghavendrakr49@gmail.com |
| Dr Arun Achar |
NRS Medical College & Hospital |
NRS Medical College & Hospital,
138, Clinical Research Dept, AJC Bose Road, Kolkata, West Bengal- 700014, India
Kolkata
WEST BENGAL |
9434017410
achararun@gmail.com |
| Dr Kalpesh Vanrajbhai kharva |
Parikh Multispeciality Health care Pvt. Ltd. |
Parikh Multispeciality Health care Pvt. Ltd. A/4, Bhagwati Park, Opp.Tube Company, Near Gajanan Complex, Old Padra Road, Vadodara, Gujarat - 390020, India
Vadodara
GUJARAT |
9925059377
dr.kalpeshkharvanm@gmail.com |
| Dr Sonal Shendkar Mahadev |
Punawale Multispeciality Hospital |
Punawale Multispeciality Hospital, Jambhe Road, Near Khandoba Mandir, Punawale, Pune- 411033
Pune
MAHARASHTRA |
9960178611
drsonalshendkar2@gmail.com |
| Dr Sweta Kumar |
Uttar Pradesh University of Medical Sciences |
Uttar Pradesh University of Medical Sciences, New OPD Building, First Floor, Clinical Research Department, Room No - 40, Saifai, Etawah - 206130
Etawah
UTTAR PRADESH |
05688276224
dermaupumssaifai.88@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Aarvy Healthcare Ethics Committee |
Approved |
| Criticare Ethics Committee |
Approved |
| Ethics Committee for Research and Human Subjects |
Approved |
| Ethics Committee Mysore Medical College and Associated Hospital |
Approved |
| IEC UTTAR PRADESH University of Medical Sciences |
Approved |
| IEC, GCS Medical College, Hospital and Research Centre |
Approved |
| Institutional Ethics Committee BIMS |
Approved |
| Institutional Ethics Committee Jawaharlal Nehru Medical College |
Approved |
| Institutional Ethics Committee, LLRM |
Approved |
| Institutional Ethics Committee, NRS Medical College & Hospital |
Approved |
| Jupiter Hospital and Research Centre Institutional Ethics Committee |
Approved |
| KMCRI Ethics Committee |
Approved |
| Parikh Institutional Ethics Committee |
Approved |
| Punawale Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Calcipotriol 50 mcg cream |
Apply cream once daily to affected areas between 07:00–09:00 AM to maintain uniformity of exposure. Calcipotriol cream is for treatment of the hands every day for 16 weeks. |
| Intervention |
Roflumilast 0.3% cream |
Apply cream once daily to affected areas between 07:00–09:00 AM to maintain uniformity of exposure. Roflumilast cream is for treatment of the hands every day for 16 weeks. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects meeting the following criteria will be included in the study:
1. Male or female subjects aged 12 years or older, inclusive.
2. Clinical diagnosis of psoriasis vulgaris of at least 6 months duration, as determined by the Investigator.
3. Females of childbearing potential must have a negative pregnancy test at Screening Visit 1 and Baseline Visit 2. In addition, sexually active females of childbearing potential must agree to use at least one form of highly effective contraception throughout the trial.
4. In good health as judged by the Investigator, based on medical history, physical examination, biochemistry laboratory tests, haematology values, and urinalysis.
5. Subjects considered reliable and capable of adhering to the Protocol and visit schedule. |
|
| ExclusionCriteria |
| Details |
Subjects will be excluded from the study for any of the following reasons:
1. Subjects with severe plaque psoriasis defined as an Investigator Global Assessment score of 4 at Screening or Baseline, or those requiring immediate systemic therapy as per the Investigator’s clinical judgment.
2. Subjects with known severe immunological diseases such as human immunodeficiency virus infection.
3. Any diagnosis of systemic sclerosis.
4. Subjects with current or untreated tuberculosis.
5. Subjects with active viral hepatitis, including hepatitis B or hepatitis C.
6. Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
7. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to initiation of the investigational product.
8. Subjects with a current or past history of malignancy, with the exception of adequately treated basal cell carcinoma.
9. Subjects who have used topical prescription treatments for psoriasis within 2 weeks prior to randomization or who plan to use them during the study period.
10. Subjects who are currently receiving treatment with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously, including erythromycin, ketoconazole, fluvoxamine, enoxacin, and cimetidine.
11. Subjects with a confirmed pregnancy at Screening or Baseline.
12. Subjects who plan to become pregnant within 6 months of study entry.
13. Subjects who are currently breastfeeding.
14. Subjects who plan to donate blood at any time during the study.
15. Subjects who are, in the Investigator’s opinion, unable or unlikely to complete the study or comply with the Protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy profile of Roflumilast 0.3% cream versus Calcipotriol 5 mcg cream in patient with Plaque Psoriasis. |
At Week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety profile of Roflumilast 0.3% cream Versus Calcipotriol 5 mcg cream, in patients with Plaque Psoriasis.
• To explore histopathological changes in psoriatic lesions following treatment with
Roflumilast 0.3% cream versus Calcipotriol 5 mcg cream in a limited subset of subjects
(i,e 30 patients in total in both the arms) undergoing skin biopsy |
Week 04, Week 08, Week 12 & Week 16. |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="330" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/03/2026 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a prospective, randomized, double blind, active controlled, multi centric Phase Three study to evaluate the efficacy and safety of Roflumilast cream compared with Calcipotriol cream in patients aged Twelve years and above with plaque psoriasis. Approximately Three Hundred Thirty patients will be randomized in a One is to One ratio to receive either study treatment once daily for Sixteen weeks. The primary endpoint is the proportion of patients achieving Investigator Global Assessment success defined as clear or almost clear with at least Two grade improvement from baseline at Week Sixteen. Secondary endpoints include Psoriasis Area and Severity Index responses and safety assessments. The study will be conducted in accordance with Good Clinical Practice and applicable regulatory guidelines in India. |