CTRI/2021/11/038001 [Registered on: 12/11/2021] Trial Registered Prospectively
Last Modified On:
03/02/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A clinical trial for topical spray of Calcipotriol & betamethasone dipropionate in mild to moderate psoriasis
Scientific Title of Study
A randomized phase III, three-parallel arm, assessor blind, multi-centre study to evaluate the efficacy, safety and tolerability of AKP02 cutaneous spray (calcipotriol (plus) betamethasone dipropionate) versus Enstilar cutaneous foam (calcipotriol (plus) betamethasone dipropionate) in subjects with mild to moderate psoriasis
Trial Acronym
AKP02
Secondary IDs if Any
Secondary ID
Identifier
CRSC20008, Version no. 02, 4 June 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Anil Avhad
Designation
Head - Cadila CRO
Affiliation
Cadila Pharmaceuticals Limited
Address
Cadila Pharmaceuticals Limited 1389, Trasad Road. Dholka – 382225. Ahmedabad. Gujarat. India. Ahmadabad GUJARAT 382225 India
Phone
02714221481
Fax
Email
anil.avhad@cadilapharma.co.in
Details of Contact Person Scientific Query
Name
Dr Sanjay Patel
Designation
Asst. General Manager
Affiliation
Cadila Pharmaceuticals Limited
Address
Cadila Pharmaceuticals Limited 1389, Trasad Road. Dholka – 382225. Ahmedabad. Gujarat. India. Ahmadabad GUJARAT 382225 India
Phone
912714221481
Fax
Email
sanjay.p@cadilapharma.co.in
Details of Contact Person Public Query
Name
Ashish Amarsheda
Designation
Deputy Manager
Affiliation
Cadila Pharmaceuticals Limited
Address
Cadila Pharmaceuticals Limited 1389, Trasad Road. Dholka – 382225. Ahmedabad. Gujarat. India. Ahmadabad GUJARAT 382225 India
Phone
912714221481
Fax
Email
ashish.a@cadilapharma.co.in
Source of Monetary or Material Support
Lipidor AB
Fogdevreten 2, SE-171 65. Solna. Sweden.
Topical foam containing calcipotriol & betamethasone, To be applied once daily for 4 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Male or non-pregnant female subjects aged >18 years with general good health and having either Fitzpatrick skin type I–III or IV–VI
2. A clinical diagnosis of stable (at least 6 months) psoriasis vulgaris on body, or body and scalp, involving 5 to 10% of BSA and PASI ≤10., that does not include the face, axilla and groin areas.
3. Mild or moderate Psoriasis on (PGA) score (2 or 3).
4. A plaque elevation of at least moderate severity (grade ≥ 3) at the target lesion site.
5. Subjects must be willing to provide written informed consent and able to understand and can comply with study requirements
ExclusionCriteria
Details
1. Subject with history of hypersensitivity to betamethasone or calcipotriol or any component of the study medication.
2. Current diagnosis of unstable forms of psoriasis in the treatment area
3. Subjects with diagnosis of mild to moderate psoriasis only in the scalp area.
4. Other inflammatory skin disease in the treatment area
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 and in need of systemic treatment
7. Subject with psoriasis lesions predominantly on palms and soles or palmo-plantar psoriasis.
8. Subjects with the diagnosis pustulosis palmo-plantaris
9. 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.
10. Use of oral estrogen therapy, excluding oral contraceptive pills
11. Females of childbearing potential not agree to utilize contraception and who are pregnant, nursing, or planning a pregnancy
12. Current significant medical problems that, in the discretion of the investigator, would put the subject at significant risk
13. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)
14. Current or past history of hypercalcemia, calcium metabolism disorder, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders.
15. Current immunosuppression and positive for serology tests like HIV, HCV & HBsAg.
16. Use of biologic treatment for psoriasis (e.g., infliximab, adalimumab, alefacept) within six months prior to Baseline.
17. Use of: 1) chemotherapy, or 2) radiation therapy, within three months prior to Baseline.
18. Use of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) oral retinoids, within two months prior to Baseline.
19. Use of: 1) systemic steroids, 2) systemic antibiotics, 3) other systemic antipsoriatic treatment, 4) PUVA therapy, 5) UVB therapy, or 6) systemic anti-inflammatory agents, within one month prior to Baseline.
20. Use of: 1) topical anti-psoriatic drugs, 2) topical corticosteroids, or 3) topical retinoids, within 2 weeks prior to Baseline.
21. Use of medicated shampoos with possible effect on psoriasis
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Comparison of change in PASI score between AKP02 cutaneous spray and Enstilar cutaneous foam
From baseline/randomization to Week 4
Secondary Outcome
Outcome
TimePoints
To evaluate the difference of change in psoriasis severity between AKP02 cutaneous spray and Enstilar cutaneous foam based on PSSI, PGA and ScPGA.
From baseline/randomization to Week 4
Change in Scalp Physician’s global assessment (ScPGA) at end of treatment compared to baseline.
At baseline/randomization and Week 4 post-randomization
Target Sample Size
Total Sample Size="294" Sample Size from India="294" Final Enrollment numbers achieved (Total)= "294" Final Enrollment numbers achieved (India)="294"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Phase-III, randomized, assessor blind, parallel group, three arms, active and placebo controlled study to study efficacy and safety for topical cutaneous spray containing calcipotriol and betamethasone dipropionate 0.005%/0.064% in subjects with mild to moderate plaque psoriasis (psoriasis vulgaris)