CTRI/2017/10/010121 [Registered on: 17/10/2017] Trial Registered Prospectively
Last Modified On:
26/11/2019
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
To evaluate efficacy and safety of clobetasol propionate topical foam vs. clobetasol propionate lotion in patients with mild to moderate plaque type psoriasis
Scientific Title of Study
A Multicentric, assessor-blind, randomized, active controlled, parallel design study comparing efficacy and safety of clobetasol propionate topical foam 0.05% vs. clobetasol propionate lotion 0.05% in patients with mild to moderate plaque type psoriasis (scalp and non-scalp)
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CT/CLOB/PSO/16 Version 2.0 dated 22/10/2016
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sushil Kumar Anand
Designation
Assistant General Manager
Affiliation
Torrent Pharmaceuticals Ltd, Torrent Research Centre
Address
Torrent Pharmaceuticals Ltd, Research centre, Village: bhat-382 428
Dist: gandhinagar, gujarat
Gandhinagar
GUJARAT
382428
India
Gandhinagar GUJARAT 382428 India
Phone
079-23969100
Fax
079-23969135
Email
sushilkumaranand@torrentpharma.com
Details of Contact Person Scientific Query
Name
Dr Sushil Kumar Anand
Designation
Assistant General Manager
Affiliation
Torrent Pharmaceuticals Ltd, Torrent Research Centre
Address
Torrent Pharmaceuticals Ltd, Research centre, Village: bhat-382 428
Dist: gandhinagar, gujarat
Gandhinagar
GUJARAT
382428
India
Gandhinagar GUJARAT 382428 India
Phone
079-23969100
Fax
079-23969135
Email
sushilkumaranand@torrentpharma.com
Details of Contact Person Public Query
Name
Dr Sushil Kumar Anand
Designation
Assistant General Manager
Affiliation
Torrent Pharmaceuticals Ltd, Torrent Research Centre
Address
Torrent Pharmaceuticals Ltd, Research centre, Village: bhat-382 428
Dist: gandhinagar, gujarat
Gandhinagar
GUJARAT
382428
India
Gandhinagar GUJARAT 382428 India
Phone
079-23969100
Fax
079-23969135
Email
sushilkumaranand@torrentpharma.com
Source of Monetary or Material Support
Torrent Pharamceutical Ltd., Research centre,
Village: Bhat-382 428
Dist. Gandhinagar, Gujarat India
Primary Sponsor
Name
Torrent Pharamceutical Ltd
Address
Torrent Pharamceutical Ltd, Research Centre, Village Bhat- 382428
Dist- Gandhinagar, Gujarat, India
Dept. of Dermatology,
Venereology and Leprosy, Father Muller Medical College and Hospital, Kankanady, Mangalore-575002, Karnataka Dakshina Kannada KARNATAKA
9845084224
rameshderma@gmail.com
Dr Ishad Aggarwal
Health Point Hospital
21, Prannath Pandit Street, Opp. Lansdown Padmapukur, Kolkata-700025, West Bengal Kolkata WEST BENGAL
8100622846
ishad1984@gmail.com
Dr Besalvadi Lingaiah Nanjunda Swamy
K. R Hospital, Mysore Medical College and Research Institute
Department of Dermatology, Skin & S.T.D, K. R Hospital, Mysore Medical College and Research Institute, Mysore -570021, Karnataka Mysore KARNATAKA
9448025219
drblnswami@gmail.com
Dr Snehal Balvant Lunge
KLES Dr Prabhakar Kore Hospital & Medical Research Centre
Maharaja Agrasen Hospital, West Punjabi Bagh, New Delhi - 110026, India
Maharaja Agrasen Hospital, West Punjabi Bagh, New Delhi - 110026, India New Delhi DELHI
9810631823
crdepartments@gmail.com
Dr Davinder Parsad
Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh-160012
Department of Dermatology, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh-160012 Chandigarh CHANDIGARH
9876060361
parsad@me.com
Dr Alok Kumar Roy
NRS Medical College & Hospital
138, AJC Bose Road, Sealdah, Kolkata, west Bengal 700014 Kolkata WEST BENGAL
9433450450
dralok1955@gmail.com
Dr Mohan Shendre
Orange City Hospital and Research institute
Orange City Hospital and Research institute
19, Pandey layout, Veer Sawarkar square,
Nagpur-440015, Maharashtra Nagpur MAHARASHTRA
9730310637
mohanshendre53@gmail.com
Dr Sukanya Banerjee
Peerless Hospitex Hospital and Research Centre Ltd
Peerless Hospitex Hospital and Research Centre Ltd,
360, Panchasayar, Kolkata-700094 Kolkata WEST BENGAL
9903746416
drsukanyabanerjee@gmail.com
Dr Piyush Gupta
Raj Jindal Hospital and Research Centre
Department of Dermatology, Raj Jindal Hospital and Research Centre, S.P.M Nagar, Bharatpur, 321001, Rajasthan
Bharatpur RAJASTHAN
9460493484
dr_piyush2001@yahoo.co.in
Dr Rajesh Datt Mehta
S.P Medical College & A G of Hospitals
Department of Skin and V.D., S.P Medical College & A G of Hospitals. Bikaner-334001, Rajasthan Bikaner RAJASTHAN
9829291502
mehtarddr@yahoo.co.in
Dr Mahajan Pradeep Madhukar
Sanjeevan Hospital
Sanjeevan Hospital, Plot No 23, Off Karve Road, Erandawane, Pune 411004, Maharashtra Pune MAHARASHTRA
07588287063
drmpradeep1@gmail.com
Dr Suneel Vartak
Sujata Birla Hospital and Medical Research Centre,
Sujata Birla Hospital and Medical Research Centre, Opposite to Bytco College, Nashik Pune Highway, Nasik Road, Nashik - 422101, Maharashtra Nashik MAHARASHTRA
Dr. Alok Kumar Roy,Ethics Committee, NRS Medical College & Hospital, 138, AJC Bose Road Kolkata, West Bengal
Approved
Dr. Anjeeta Dhawan,Institutional Ethics Committee, Maharaja Agrasen Hospital, R. No. - 614, 6th Floor, west Punjabi Bagh, New Delhi- 110026
Approved
Dr. Besalvadi Lingaiah Nanjunda Swamy, Institutional Ethics Committee, Mysore Medical College and Research Institute and Associated Hospitals, Irwin Road, Mysore, Karnataka
Approved
Dr. Davinder Parsad, Institutional Ethics Committee, PGIMER , Chandigarh
Approved
Dr. Ishad Aggarwal, Health Point Ethics committee Health Point Multi-Speciality Hospital 21, Prannath Pandit Street Opp. Lansdown Padmapukur Kolkata
Approved
Dr. Mahajan Pradeep Madhukar,Ethics Committee Sanjeevan Hospital, Erandavne, Pune, Maharashtra
Approved
Dr. Mohan Shendre,Institutional Ethics Committee, Orange City Hospital and research Institutional, Nagpur-440015, Maharashtra
Approved
Dr. Piyush Gupta, Institutional Ethics Committee, Raj Jindal Hospital and Research Centre, S.P.M Nagar, Bharatpur,Rajasthan
Approved
Dr. Rajesh Datt Mehta, Ethics Committee, S.P Medical College & A G of Hospitals, Bikaner
Approved
Dr. Ramesh Bhat, Father Muller Ethics Committee situated at Father Muller Road, Kankanady, Mangalore
Approved
Dr. Shatrughan Sahay, Institutional Ethics Committee for Ajanta Hospital and IVF Centre, 765 ABC Complex, Alambagh, Lucknow
Approved
Dr. Snehal Lunge, Ethics Committee, KLE University, Belgaum, Karnataka
Approved
Dr. Sukanya Banerjee, Clinical Research Ethics Committee Peerless Hospitex Hospital and Research Center Limited, 360, Panchasayar, Kolkata-700094, West Bengal
Approved
Dr. Suneel Vartak, Yash Society Institutional Ethics Committee Sujata Birla Hospital & Medical Research Center, Nashik, Maharashtra
Mild to moderate plaque type psoriasis (scalp and non-scalp), (1) ICD-10 Condition: L400||Psoriasis vulgaris,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Clobetasol propionate lotion 0.05%
Self-administered by patients twice daily (morning and evening) for two weeks
Intervention
Clobetasol propionate topical foam 0.05%
Self-administered by patients twice daily (morning and evening) for two weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Male and female patients of age 18 years or older.
2. Patients with mild to moderate plaque-type psoriasis, as defined by ISGA score of 2-3 at enrolment involving ≤10 % of total body surface area.
3. Patients must have a target lesion (>2 cm2) with a score of 2-3 (on a scale of 0 to 5) for each of erythema, scaling and plaque thickness.
4. Patients with ability and willingness to follow the study procedures attend all scheduled visits and successfully complete the study.
5. Patients willing to give informed consent
ExclusionCriteria
Details
1. Patients with known allergy or sensitivity to clobetasol or other topical corticosteroids or any other component of investigational formulation.
2. Patients whose psoriasis involves the face, nails, palms, soles or intertriginous sites.
3. Severe, uncontrolled manifestation of any disease including psoriasis.
4. Use of systemic antipsoriatic therapy (e.g., corticosteroids, retinoids, methotrexate, psoralen and ultraviolet light, cyclosporine) within the past 4 weeks
5. Patients who have taken or currently on biologics treatment such as e.g., alefacept, etanercept, adalimumab.
6. Use of topical treatment which have a known beneficial effect on psoriasis, including but not limited to corticosteroid, retinoids, vitamin D derivatives, tar or anthralin within the past 2 weeks.
7. Introduction or change in dosage of systemic medications for other medical conditions which are known to affect psoriasis (e.g., lithium, β-blockers etc.) within the past 4 weeks.
8. The expectation of exposure to strong sunlight or UV therapy during the course of the study; or any condition that, in the judgment of the investigator, would put the patient at unacceptable risk for participation in the study.
9. Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
10. History of malignancy in last 5 years.
11. Current drug or alcohol abuse.
12. Patient with clinically significant abnormal laboratory investigation.
13. Use of any investigational drug or device therapy within the past 4 weeks.
14. Pregnant women, women who are breast feeding or women of reproductive potential who are neither surgically sterilized nor willing to use effective contraceptive methods during the course of the study.
15. Men wishing to father a child during the course of the study or not ready to use adequate means of contraception throughout the study.
16. Patient who in the opinion of the investigator would not be suitable candidate for participation in the study.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Percentage of patients with Investigator’s static global assessment scores of 0 or 1 at week 2.
Screening, Day 0, Week 1 and Week 2
Secondary Outcome
Outcome
TimePoints
Percentage of patients with Investigator’s static global assessment scores of 0 or 1 in scalp and non-scalp psoriasis groups at week 2
Screening, Day 0, Week 1 and Week 2
Mean change in scores of target lesion signs of psoriasis (erythema, scaling, plaque thickness) and pruritus from baseline to week 2
Screening, Day 0, Week 1 and Week 2
Percentage of patients with Subject’s global assessment score of 0 or 1 at week 2
Day 0, Week 1 and Week 2
Comparison of mean vehicle acceptance score between treatment groups at week 2
Week 2
Target Sample Size
Total Sample Size="232" Sample Size from India="232" Final Enrollment numbers achieved (Total)= "232" Final Enrollment numbers achieved (India)="232"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Psoriasis is a chronic, inflammatory skin disorder that causes physical discomfort and psychological distress in 1-5% of the population worldwide. Clobetasol Propionate (CP) is a synthetic super-potent fluorinated topical corticosteroid, used for the treatment of psoriasis and available in variety of formulations such as ointments, creams, lotions, solutions and gels at a concentration of 0.05% regardless of vehicle. Foam dosage form is newer and excellent for topical application of medication. Due to unique film forming and breaking characteristics, foam can be easily transferred from the container to the intended skin application site. Several studies reported that patient gives higher preference to foam than other traditional dosage form like cream or ointment due to ease of application, easy and uniform spreading on skin surface, less stickiness, less greasy feeling, quick drying after application and relatively less residue on skin surface after application. The present study is planned to compare the efficacy and safety of Torrent’s clobetasol propionate topical foam 0.05% with clobetasol propionate lotion 0.05% in patients of mild to moderate plaque type psoriasis.