CTRI/2026/02/105052 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On:
30/04/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Evaluate Effectiveness and Safeness of Roflumilast 0.3 percent Cream Compared to Calcipotriol 0.005 percent Ointment in Patients with Chronic Plaque Psoriasis
Scientific Title of Study
A Randomized, Multi-Centric, Two-Arm, Active-Controlled, Parallel-group, Assessor-Blind, Phase III, Comparative Study to Evaluate Efficacy and Safety of Roflumilast 0.3 percent Cream Compared to Calcipotriol 0.005 percent Ointment in Patients with Chronic Plaque Psoriasis
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/25/003, Version No. 2.0, 22/AUG/2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
Associate Vice President & Head India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House Plot No 201 B1 Western Express Highway Goregaon E
Mumbai MAHARASHTRA 400063 India
Phone
9819767704
Fax
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Supriya Sonowal
Designation
Senior Manager Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House Plot No 201 B1 Western Express Highway Goregaon E
Mumbai MAHARASHTRA 400063 India
Phone
9427003728
Fax
Email
Supriya.Sonowal1@sunpharma.com
Details of Contact Person Public Query
Name
Digambar Tornale
Designation
Manager India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House Plot No 201 B1 Western Express Highway Goregaon E
Mumbai MAHARASHTRA 400063 India
Phone
9960814158
Fax
Email
digambar.tornale@sunpharma.com
Source of Monetary or Material Support
Sun Pharmaceutical Industries Limited (SPIL)
Primary Sponsor
Name
Sun Pharmaceutical Industries Limited (SPIL)
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Room no.13, Department of Dermatology,Swaroop Nagar, Kanpur, 208002, U.P. India Kanpur Nagar UTTAR PRADESH
9450136374
Devprakash.80@gmail.com
Dr Roshniaben Abdulbhai Vahora
GMERS Medical College
OPD No. 205 (Dept. of Skin & V.D.), GMERS Medical College,
Gotri, Vadodara – 390 021, Gujarat, India.
Vadodara GUJARAT
9824097310
drroshnivhora@ymail.com
Dr Patel Krina Bharat
GMERS Medical College and Civil Hospital
Department of Dermatology, Sola, Ahmedabad Gujrat 380060 Ahmadabad GUJARAT
9227222221
drkpatel66@yahoo.com
Dr Konakanchi Venkata Chalam
Government General Hospital, Cantonment, Vizianagaram
Department of Dermatology, Government Medical College,
Government General Hospital, Cantonment, Vizianagaram-535003, Andhra Pradesh, India.
Vizianagaram ANDHRA PRADESH
9848398923
Drvenkatachalamresearch@gmail.com
Dr Patro Nibedita
Hi-Tech Medical College & Hospital
Dep of skin & VD, Ground Floor, Room no 1, Pandra, Rasulgarh, Bhubaneswar, Khordha, Odisha-751025 Khordha ORISSA
9937740401
nibeditapatro@gmail.com
Dr Turpati Narayana Rao
Indus Hospital
KGH Down Road, Jagadamba, Visakhapatnam-530002, Andhra Pradesh, India. Visakhapatnam ANDHRA PRADESH
9849129912
drtnarayanaraoresearch@gmail.com
Dr Santanu Banerjee
Jaipur National University Institute for Medical Sciences and Research Centre
Jaipur National University Institute for Medical Sciences and Research Centre,
Near New RTO Office, Agra Road, Jagatpura, Jaipur, Rajasthan – 302017
Jaipur RAJASTHAN
9257036514
drsantanu.derma@gmail.com
Dr Raj Kumar Kothiwala
Jawahar Lal Nehru Medical College
Department of Dermatology,Kala Bagh, Ajmer-305001, Rajasthan Ajmer RAJASTHAN
7703841956
Doctor.rajkumark@gmail.com
Dr Kethireddi S Divya
King George Hospital
Department of Dermatology, Andhra Medical College, Maharanipeta, Visakhapatnam- 530002, Andhra Pradesh, India. Visakhapatnam ANDHRA PRADESH
8985183682
drsusmithadivyaresearch@gmail.com
Dr Parasramani Shrichand Gordhandas
Lilavati Hospital and Research Centre
Room no 21, Ground Floor, Department of Dermo Cosmetology Laser Centre,, Bandra Reclamation, Bandra West, Mumbai Maharashtra 400050 Mumbai MAHARASHTRA
9821034842
sparasramani@hotmail.com
Dr Bawankar Bhushan Subhaschandra
Lion Tarachand Bapa Hospital and Research Centre
Department of Dermatology, C.U Shah Complex Jain Society Sion (W)Mumbai Maharashtra – 400022 Mumbai MAHARASHTRA
9923816392
Bhushan52kar@gmail.com
Dr Suvash Sahu
M.L.B Medical College
Kanpur Road, Jhansi 284128 (U.P.) India Jhansi UTTAR PRADESH
9540498717
sahusuvash@gmail.com
Dr Shashikumar B M
Mandya Institute of Medical Science
No 13, Department of Dermatology, Bangalore- Mysore highway Mandya- 571401 Mysore KARNATAKA
9886197902
Shashikumarbm@gmail.com
Dr Kingshuk Chatterjee
NRS Medical College and Hospital
Department of Dermatology,138, A.J.C. Bose Road, Kolkata - 700014, West Bengal India Kolkata WEST BENGAL
9932641801
Klose2kingonly@gmail.com
Dr Patil Mamta Rajendra
Ojas Multispeciality Hospital
Clinical research Department, Sr no 203/1, Bhondave Chowk, D.Y Patil College Road, Ravet Pune -412101. Pune MAHARASHTRA
7738927929
Dr.mamta.ojas@gmail.com
Dr K BHUMESH KUMAR
Osmania General Hospital
Room no 222, 1st Floor, Osmania Medical College Afzalgunj, Hyderabad- 500012, Telangana India. Hyderabad TELANGANA
9848665595
Drbhumesh124@gmail.com
Dr Sunil Dogra
Post Graduate institute of medical education and research
Room no 5006, Level-5, New OPD, Department of Dermatology, Venerology & Leprology, Chandigarh Sector 12, 160012, India. Chandigarh CHANDIGARH
9855005941
sundogra@hotmail.com
Dr Hari Kishan Kumar Y
Rajarajeswari Medical College and Hospital,
Department of Dermatology, No 202 Kambipura, Mysore Road, Bangalore- 560074 Bangalore KARNATAKA
Institutional Ethics Committee, JNU Institute for Medical Sciences and Research Centre
Approved
Institutional Human Ethics Committee
Approved
MLB Medical College Institutional Ethics Committee
Approved
Ojas Multispeciality Hospital Ethics Committee
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L988||Other specified disorders of the skin and subcutaneous tissue,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Calcipotriol 0.005 percent ointment
Route: Topical
Twice daily to affected areas of plaque psoriasis. Maximum weekly dose should not exceed 100 g.
Total study period: 40 weeks
Intervention
Roflumilast 0.3 percent w/w Cream
Route: Topical
Once daily to affected areas of plaque psoriasis. For topical use only. Not for
ophthalmic, oral, or intravaginal use.
Total study period: 40 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients willing to provide written informed consent
2. Patients with a confirmed clinical diagnosis of plaque psoriasis (psoriasis vulgaris) fulfilling the following criteria at Screening:
a) Patient was diagnosed at least 6 months prior to Screening
b) The lesions must involve the trunk and or extremities [excluding face, scalp, palms, soles and intertriginous areas] and is amenable to topical treatment
c) The affected area should be greater than or equal to 2 percent to less than or equal to 20 percent of body surface area (BSA)
d) Psoriasis Area Severity Index (PASI) score of greater than or equal to 2 at Screening
e) Stable disease (without any new lesions or progression of existing lesions) in last 4 weeks prior to Screening and during Screening and washout period
3. Patients who agree to discontinue all agents used to treat plaque psoriasis from Screening through the EOS visit
4. Women of childbearing potential must have a negative urine pregnancy test prior to Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of study (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence OR non-hormonal contraception [e.g. condoms with spermicide])
5. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period) [No sperm donation is allowed during the study period]
ExclusionCriteria
Details
Patient will be excluded if any of the exclusion criteria listed below is met:
1. Patients with known hypersensitivity or any other contraindication to any of the Investigational products or its component
2. Patients with unstable forms of psoriasis (for example but not limited to: guttate, erythrodermic, pustular psoriasis, palmoplantar psoriasis, drug-induced psoriasis, etc.)
3. Patients with history of any other skin disorder (for example but not limited to: pigmentation, extensive scarring, pigmented lesions, sunburn, acne, ulcer, atrophic striae, ichthyosis, etc.), that in the opinion of Investigator, would interfere with the study medication application or efficacy and safety assessments
4. Patients with history of Vitamin D toxicity
5. Patients with previous treatment with topical Roflumilast or topical calcipotriol
6. Patients using any of the following drugs/ treatments:
a. Strong CYP450 inhibitors (like: ketoconazole, itraconazole, ritonavir, indinavir, clarithromycin, etc.) [Note: Patients can be included after 2 weeks of washout period]
b. Strong CYP450 inducers (like: barbiturates, nevirapine, phenytoin, rifampicin, etc.) [Note: Patients can be included after 2 weeks of washout period]
c. Topical agents for psoriasis (including but not limited to: corticosteroids [Class 1, 2 and 3], Vitamin D analogues, retinoids, PDE4 inhibitors, salicylic acid, pimecrolimus, tacrolimus, anthralin, tar, etc.) [Note: Patients can be included after 2 weeks of washout period]
d. Topical Class 4 corticosteroids [Note: Patients can be included after 4 weeks of washout period]
e. Systemic immunosuppressing agents (like fumaric acid, corticosteroids, methotrexate, retinoids, PDE4 inhibitors [including oral Roflumilast], cyclosporine, etc.) [Note: Patients can be included after 4 weeks of washout period]
f. Any type of Laser or Phototherapy [Note: Patients can be included if they have completed 4 weeks of washout period]
g. Biological agents [Note: Patients can be included if they have completed 8 weeks or 5 half-lives (whichever is longer) of washout period post-last dose]
7. Patients with history of any clinically significant medical and or psychological condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results [for example but not limited to: hepatic impairment (if ALT greater than or equal to 3 x upper limit of normal [ULN] OR AST greater than or equal to 3 x ULN OR ALP greater than or equal to 3 x ULN OR total bilirubin greater than or equal to 1.5 x ULN), renal impairment (Serum creatinine greater than or equal to 2 x ULN), hypercalcemia (serum calcium greater than or equal to 12 mg/dL), epilepsy or seizure disorder or any neurological disorder, uncontrolled diabetes (HbA1c greater than or equal to 9 percent)]
8. Pregnant and or lactating female
9. Patients with history of severe depression or suicidal ideation
10. Patient with positive report of human immunodeficiency virus (HIV) and/or hepatitis B virus (HbsAg) and/or hepatitis C virus (HCV) infection at Screening
11. Patients with history of any malignancy in the last 5 years prior to Screening or undergoing cancer chemo or radiotherapy
12. Patients with known alcohol or other substance abuse within last one year prior to Screening
13. Patients who have participated in another Investigational study within the 3 months prior to Screening or planning to participate in another clinical trial during the study
14. Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor or the Investigator
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
On-site computer system
Blinding/Masking
Investigator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of patients achieving 75% reduction from baseline in PASI score (PASI-75)
12 weeks
Secondary Outcome
Outcome
TimePoints
Proportion of patients achieving 50% reduction from baseline in PASI score (PASI-50)
Proportion of patients achieving 90% reduction from baseline in PASI score (PASI-90)
Percentage change from baseline in PASI score
Percentage change from baseline in affected BSA
Proportion of patients achieving a score of “0” or “1” in Investigator’s Global Assessment of Disease (IGA) scale
Change from baseline in DLQI total score
Proportion of participants with treatment emergent (TEAEs) and serious adverse events (SAEs)
Proportion of patients achieving 75% reduction from baseline in PASI score (PASI-75)
Week 24 and 36
Proportion of patients achieving 50% reduction from baseline in PASI score (PASI-50)
Week 24 and 36
Proportion of patients achieving 90 % reduction from baseline in PASI score (PASI-90)
Week 24 and 36.
Percentage change from baseline in PASI score.
Percentage change from baseline in affected BSA
Proportion of patients achieving a score of “0” or “1” in Investigator’s Global Assessment of Disease (IGA) scale
Change from baseline in DLQI total score
Changes in Trozak histologic grading system for psoriasis based on biopsy report
Proportion of participants with TEAEs and SAEs
Target Sample Size
Total Sample Size="454" Sample Size from India="454" 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
Phase 3
Date of First Enrollment (India)
03/03/2026
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="9" Days="10"
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
This Phase III, randomized, assessor-blind, multi-center study aims to
compare the safety and efficacy of Roflumilast 0.3 percent cream with
Calcipotriol 0.005 percent ointment in patients diagnosed with chronic plaque
psoriasis. The trial will be conducted across 15 to 20 qualified centers in
India and will begin only after receiving regulatory and ethics committee
approvals.
A total of approximately 454 patients will be enrolled, with equal
distribution across both treatment arms. Participants will be randomized in a
1:1 ratio, stratified by baseline affected body surface area (BSA less than 10
percent and greater than or equal to 10 percent). Eligible patients must have a
confirmed diagnosis of plaque psoriasis for at least six months, with lesions
on the trunk or extremities (excluding face, scalp, palms, soles, and
intertriginous areas), affecting 2 to 20 percent BSA and a PASI score of greater than or equal
to 2.
The primary end point of the study is proportion of patients achieving
75 percent reduction from baseline in PASI score at Week 12. Efficacy will be
assessed using percent BSA, PASI, and IGA scores, along with DLQI to evaluate
patient-reported outcomes. Target lesion photographs will be taken at specific
visits. Safety evaluations will include monitoring adverse events, vital signs,
ECG, physical exams, and lab tests covering hematology, liver and kidney
function, electrolytes, HbA1c, and urinalysis.