CTRI/2024/07/071444 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On:
24/03/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
Comparison of AKP02G2 Cutaneous Spray versus Enstilar Cutaneous Foam and Placebo in the treatment of Mild to Moderate Psoriasis.
Scientific Title of Study
A Randomized, Phase III, Three-Parallel Arm, Assessor-Blind, Active and Placebo Controlled Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of AKP02G2 Cutaneous Spray versus Enstilar Cutaneous Foam in Subjects with Mild to Moderate Psoriasis.
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: C2A03333 Version: 02 Date: 20 Feb 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations
Affiliation
Cliantha Research
Address
Cliantha Research, Cliantha Corporate TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
07966219500
Fax
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Associate Director- II– Clinical Trial Medical Services
Affiliation
Cliantha Research
Address
Cliantha Research, Cliantha Corporate TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
07966219500
Fax
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Devesh Verma
Designation
Director - Clinical Trials Operations
Affiliation
Cliantha Research
Address
Cliantha Research, Cliantha Corporate TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
919712908404
Fax
Email
dverma@cliantha.com
Source of Monetary or Material Support
Lipidor AB, C/O Ekonomistubben, PO Box 55931, SE-10216, Stockholm, Sweden, Tel 46 70-7192200
Primary Sponsor
Name
Lipidor AB
Address
C/O Ekonomistubben, PO Box 55931, SE-10216, Stockholm, Sweden, Tel 46 70-7192200
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Cliantha Research limited
Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Apex Hospital Pvt Ltd, S P 4 & 6 Malviya Industrial Area, Malviya Nagar, Jaipur - 302017, Rajasthan, India Jaipur RAJASTHAN
9314661504
drneetusidana95@gmail.com
Dr Shyamanta Barua
Assam Medical College and Hospital
Department of Dermatology, Assam Medical College and Hospital, AMC Road, Barbari, Dibrugarh, Assam 786002
Dibrugarh ASSAM
9435546944
drshyamanta@gmail.com
Dr Suneel Vartak
Assured Care Plus Hospital
4th & 5th Floor, Star Plus Complex, Lam road, Near Muktidham Temple, Opp. NMC Divisional office, Nashik Road, Nashik 422101, Maharashtra, India Nashik MAHARASHTRA
9373901829
suneelvarka@gmail.com
Dr Ashma Surani
Care and Cure Multispecialty Hospital
OPD Room, First Floor, Besides Nilamkunj Society, Nr Gokulnathji Haveli Mira Cinema Cross Road, Bhairavnath, Shah Alam Rd, Maninagar, Ahmedabad - 380028, Gujarat Ahmadabad GUJARAT
9714554273
ashmasurani786@gmail.com
Dr Wani Imran Majid
Cutis Institute of Dermatology
Cutis Institute of Dermatology,1st floor Hyderpora, Srinagar - 190014, Jammu and Kashmir Srinagar JAMMU & KASHMIR
7006971891
drimranmajid@gmail.com
Dr Rashmi Mahajan
Dhiraj Hospital Sumandeep Vidyapeeth Deemed to be University
Dhiraj Hospital, Department of Skin and VD, Sumandeep Vidyapeeth Deemed to be University, At. & Po. Piparia Ta Waghodia, Dist Vadodara, Gujarat, India-391760
Vadodara GUJARAT
9227676607
rsoodmahajan@gmail.com
Dr Doi Mo Shadab M Rafik Ahmedbhai
HCC Happiness Care and Cure Multispeciality Hospital
Room No. 5, Clinical Research Room, Second Floor, Dermatology Department, AMC MET Medical College, Near Rambaug, Maninagar, Ahmedabad - 380008, Gujarat Ahmadabad GUJARAT
9824058208
patelneela1974@yahoo.co.in
Dr Swati Engineer
Shraddha Multispeciality Hospital
OPD Room, First Floor, Vaibhav Complex, Near Municipal Hospital, Kalol, Gandhinagar – 382721, Gujarat
Gandhinagar GUJARAT
Institutional Ethics Committee Assam Medical College
Approved
Institutional Ethics Committee Assured Care Plus Hospital
Approved
Institutional Ethics Committee IUST
Approved
Institutional Ethics Committee IUST
Approved
Institutional Ethics Committee, SV
Approved
lnstitutional Ethics Committee Rajarajeswari Medical College and Hospital
Approved
Parth Hospital Ethics Committee
Approved
Riddhi Medical Nursing Home Institutional Ethics Committee
Approved
Riddhi Medical Nursing Home Institutional Ethics Committee
Approved
Riddhi Medical Nursing Home Institutional Ethics Committee
Approved
Shree Siddhivinayak Hospital Ethics Committee
Approved
Shubham Institutional Ethics Committee
Approved
Triveni Polyclinic Institutional Ethics committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L408||Other psoriasis,
Intervention / Comparator Agent
Type
Name
Details
Intervention
AKP02G2 cutaneous spray, Lipidor AB.
Each gram contains
50 mcg of calcipotriol and 0.643 mg of betamethasone
dipropionate.
Comparator Agent
Enstilar 50 micrograms/g + 0.5 mg/g cutaneous foam, LEO
Pharma.
Each gram contains 50 mcg of calcipotriol and 0.643 mg of betamethasone dipropionate.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Male or non-pregnant female subject aged greater than 18 years.
2. A clinical diagnosis of stable (at least 6 months) psoriasis vulgaris on body, or body and scalp, involving 5 to 10 percent of body surface area (BSA) and PASI ≤ 10., that does not include the face, axilla and groin areas.
3. Mild or moderate Psoriasis on Physician Global Assessment (PGA) score (grade 2 - 3).
4. A plaque elevation of at least moderate severity (grade ≥ 3) at the target lesion site. The most severe lesion at randomization/baseline should be identified as the target lesion.
5. Subject must be willing to provide written informed consent.
6. Subject must be willing and able to understand and can comply with study requirements, apply the medication as instructed and be able to complete the study.
7. Subject must be in general good health as judged by the Investigator, based on medical history and physical examination.
ExclusionCriteria
Details
1. Subject with history of hypersensitivity to betamethasone or calcipotriol or any component of the test or reference product or placebo.
2. Current diagnosis of unstable forms of psoriasis in the treatment area including guttate, erythrodermic, exfoliative, or pustular psoriasis.
3. Subject with diagnosis of mild to moderate psoriasis only in the scalp area.
4. Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris (e.g., atopic dermatitis, contact dermatitis, tinea corporis and seborrheic dermatitis).
5. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas, which could interfere with the rating of efficacy parameters.
6. Subject with history of psoriasis unresponsive to topical treatments.
7. Subject with psoriasis lesions predominantly on palms and soles or palmo-plantar area.
8. Subject with the diagnosis pustulosis palmo-plantaris.
9. Subject in need of systemic treatment.
10. Ongoing use of other psoriasis treatment including but not limited to topical or systemic corticosteroids, other topical medications (i.e. coal tar), oral or biologic medications for the treatment of psoriasis, and UV therapy.
11. Use of oral estrogen therapy, excluding oral contraceptive pills within one month prior to randomization/baseline.
12. Females who are pregnant, nursing, or planning a pregnancy.
13. Females of childbearing potential who do not agree to utilize an adequate form of contraception.
14. Current significant medical problems that, in the discretion of the investigator, would put the subject at significant risk.
15. Use of any investigational drug within 4 weeks prior to randomization, or five pharmacokinetic/ pharmacodynamics half-lives, if known (whichever is longer).
16. Current or past history of hypercalcemia, calcium metabolism disorder, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders.
17. Current immunosuppression.
18. Use of biologic or targeted treatment for psoriasis (e.g., infliximab, adalimumab, alefacept or JAK inhibitors) within six months prior to randomization/baseline.
19. Use of: a) chemotherapy, or b) radiation therapy, within three months prior to randomization/baseline.
20. Use of: a) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or b) oral retinoids, within two months prior to randomization/baseline.
21. Use of: a) systemic steroids, b) systemic antibiotics, c) other systemic anti-psoriatic treatment, d) PUVA therapy, e) UVB therapy, or f) systemic anti-inflammatory agents, within one month prior to randomization/baseline.
22. Use of: a) topical anti-psoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriol, tazarotene), b) topical corticosteroids, or c) topical retinoids, within 2 weeks prior to randomization/baseline.
23. Use of medicated shampoos with possible effect on psoriasis.
24. Subject with positive serology tests like HIV, HCV & HBsAg.
25. Any other condition that, in the Investigator’s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
Method of Generating Random Sequence
Other
Method of Concealment
Not Applicable
Blinding/Masking
Investigator Blinded
Primary Outcome
Outcome
TimePoints
Percentage change in Psoriasis area and severity index (PASI) score from randomization/baseline to the end of treatment.
[Time Frame: From randomization/baseline to Week 4 (Day 29±4)]
Secondary Outcome
Outcome
TimePoints
a. Percentage change in Psoriasis scalp severity index (PSSI) scores from baseline to end of treatment.
b. Change in Physician’s global assessment (PGA) at end of treatment compared to baseline
c. Change in Scalp Physician’s global assessment (ScPGA) at end of treatment compared to baseline.
d. Frequency of adverse events and serious adverse events or any event of clinical significance.
[Time Frame: At randomization/baseline and Week 4 (Day 29±4)]
[Time Frame: At randomization/baseline and Week 4 (Day 29±4)]
[Time Frame: At randomization/baseline and Week 4 (Day 29±4)]
[Time Frame: Randomization/baseline through to end of study]
Target Sample Size
Total Sample Size="294" Sample Size from India="294" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This phase III study has been designed to compare efficacy
and safety of Test product (AKP02G2 cutaneous spray) of Lipidor AB with
reference product (Enstilar cutaneous foam) of LEO Pharma in subjects with mild to moderate psoriasis
and the impact of this therapy
in their quality of life.