Back to resultsA Clinical Trial to Evaluate Efficacy and Safety of Two Different Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis (AKP01)
Primary Purpose
Mild to Moderate Plaque Psoriasis
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Calcipotriol/AKVANO, 50 μg/g cutaneous solution
Calcipotriol Ointment 50 micrograms/g
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mild to Moderate Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Male or female patients (Non-pregnant) of plaque psoriasis aged 18 to 65 years having either Fitzpatrick skin type I-III or IV-VI.<br/>
- Diagnosis of stable plaque psoriasis for 6 month by a dermatologist with lesions on arms, legs or trunk.
- Mild to moderate psoriasis on Physician's global assessment (PGA),
- Body Surface Area (BSA) involvement of 5-10% (both included) and PASI ≥ 5.
- Patients must be willing to provide written informed consent and willing to comply with study requirements
Exclusion Criteria:
- Predominantly palmo-plantar, flexural, scalp and nail location of psoriasis
- Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis.
- Patient with any uncontrolled systemic disease
- Patient with positive serology tests like HIV, HCV & HBsAg.
- Patient with presence of any skin disease that might interfere with the diagnosis or evaluation of the test medications.
- Patient with spontaneously improving or rapidly deteriorating plaque psoriasis.
- Use of systemic agents within four weeks prior to screening.
- Use of biologic agents within four weeks prior to study entry.
- Use of topical drugs that might alter the course of psoriasis or has received ultraviolet B treatment within two weeks prior to study entry.
- Use of phototherapy with psoralen ultraviolet A treatment within four weeks prior to study entry.
- Known sensitivity to any of the study treatments and/or study treatment's components.
- Need for surgery or hospitalization during the study
- Pregnant or nursing Female patient or planning a pregnancy
- Concurrent involvement in any other clinical study within 30 days prior to entering the study
Sites / Locations
- AC Subbareddy Government Hospital
- Downtown Hospital
- Marwari Hospital & Research Centre
- Sanjeevani CBCC USA Cancer Hospital
- Kanoria Hospital & Research Centre
- GMERS Medical College & Hospital
- Dhiraj General Hospital
- KLES Dr. Prabhakar Kore Hospital & Medical Reserach Centre
- Government Medical College
- Gokuldas Tejpal Hospital Grant Government Medical College & Sir JJ Group of Hospital
- Dr. D.Y. Patil Hospital
- Midland Healthcare & Research Center
- Surya Super Speciality Hospital
- Postgraduate Institute of Medical Education and Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Calcipotriol/AKVANO, 50 μg/g cutaneous solution
Calcipotriol Ointment 50 micrograms/g, Sandoz
Placebo
Arm Description
Spray formulation applied topically, twice daily, for the duration of 8 weeks.
Ointment applied topically, twice daily, for the duration of 8 weeks.
Spray formulation applied topically, twice daily, for the duration of 8 weeks.
Outcomes
Primary Outcome Measures
Change in Psoriasis Area and Severity Index
Assessment of severity of psoriasis by comparing the change in Psoriasis Area and Severity Index between test and comparator (score ranging from 0 to 72, higher score means worsening of the disease)
Secondary Outcome Measures
Assessment of Physician's Global Assessment (PGA)
Proportion of patients achieving PGA 0 or 1 with Test and comparator
Incidence of Adverse Events and SAEs (Safety and Tolerability)
Incidence of Adverse Event and Serious Adverse Event between three treatment arms
More than 50 % reduction in PASI Score (PASI 50)
Proportion of patients achieving >50 % reduction in PASI Score (PASI50) with Test and comparator
More than 75 % reduction in PASI Score (PASI 75)
Proportion of patients achieving >75 % reduction in PASI Score (PASI75) with Test and comparator.
Change in Irritation based on Visual Analogue scale (VAS)
To evaluate change in irritation based on Visual Analogue scale between three treatment arms Visual Analogue scale (VAS) ranges from 0 to 10 (higher scores mean worse outcome)
Change in itching based on Visual Analogue scale
To evaluate change in itching based on Visual Analogue scale between three treatment arms, Visual Analogue scale (VAS) ranges from 0 to 10 (higher scores mean worse outcome)
Full Information
NCT ID
NCT05174598
First Posted
November 30, 2021
Last Updated
February 15, 2022
Sponsor
Cadila Pharnmaceuticals
Collaborators
Lipidor AB, Svärdvägen 13 SE-182 33 Danderyd, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT05174598
Brief Title
A Clinical Trial to Evaluate Efficacy and Safety of Two Different Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis
Acronym
AKP01
Official Title
A Phase III, Multicentre, Randomized, Observer Blind, Parallel Group, Three Arms, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Topically Applied Calcipotriol/AKVANO 50 μg/g Cutaneous Solution Against Calcipotriol Ointment 50 Micrograms/g, Sandoz and Placebo in Patients With Mild to Moderate Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
November 6, 2019 (Actual)
Study Completion Date
December 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cadila Pharnmaceuticals
Collaborators
Lipidor AB, Svärdvägen 13 SE-182 33 Danderyd, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a Phase III, multicentre, randomized, observer blind, parallel group, three arms, controlled clinical trial to evaluate the efficacy and safety of topically applied Calcipotriol/AKVANO 50 μg/g cutaneous solution against Calcipotriol Ointment 50 micrograms/g, Sandoz and placebo in patients with mild to moderate plaque psoriasis
Detailed Description
Total 278 patients with mild to moderate plaque psoriasis were randomized into the study. Study medications were applied twice daily for 8 weeks of study duration.
Patient's condition was assessed using of Physician's Global Assessment (PGA) and PASI Scale.
Primary objective of this study is to assess the therapeutic equivalence of Calcipotriol/AKVANO, 50 μg/g cutaneous solution with Calcipotriol Ointment 50 micrograms/g, Sandoz based on PASI score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcipotriol/AKVANO, 50 μg/g cutaneous solution
Arm Type
Experimental
Arm Description
Spray formulation applied topically, twice daily, for the duration of 8 weeks.
Arm Title
Calcipotriol Ointment 50 micrograms/g, Sandoz
Arm Type
Active Comparator
Arm Description
Ointment applied topically, twice daily, for the duration of 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Spray formulation applied topically, twice daily, for the duration of 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Calcipotriol/AKVANO, 50 μg/g cutaneous solution
Intervention Description
Topical spray formulation containing Calcipotriol 50 μg/g. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Calcipotriol Ointment 50 micrograms/g
Intervention Description
Topical Ointment formulation containing Calcipotriol 50 micrograms/g. Twice daily treatment by applying on a psoriasis affected area for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Topical spray formulation containing Vehicle of test formulation. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.
Primary Outcome Measure Information:
Title
Change in Psoriasis Area and Severity Index
Description
Assessment of severity of psoriasis by comparing the change in Psoriasis Area and Severity Index between test and comparator (score ranging from 0 to 72, higher score means worsening of the disease)
Time Frame
Baseline to 8 weeks Post-randomization
Secondary Outcome Measure Information:
Title
Assessment of Physician's Global Assessment (PGA)
Description
Proportion of patients achieving PGA 0 or 1 with Test and comparator
Time Frame
Baseline to 2, 4 and 8 weeks of treatment Post-randomization
Title
Incidence of Adverse Events and SAEs (Safety and Tolerability)
Description
Incidence of Adverse Event and Serious Adverse Event between three treatment arms
Time Frame
Till 8 weeks Post-randomization
Title
More than 50 % reduction in PASI Score (PASI 50)
Description
Proportion of patients achieving >50 % reduction in PASI Score (PASI50) with Test and comparator
Time Frame
Baseline to 2, 4 and 8 weeks of treatment Post-randomization
Title
More than 75 % reduction in PASI Score (PASI 75)
Description
Proportion of patients achieving >75 % reduction in PASI Score (PASI75) with Test and comparator.
Time Frame
Baseline to 2, 4 and 8 weeks of treatment Post-randomization
Title
Change in Irritation based on Visual Analogue scale (VAS)
Description
To evaluate change in irritation based on Visual Analogue scale between three treatment arms Visual Analogue scale (VAS) ranges from 0 to 10 (higher scores mean worse outcome)
Time Frame
Baseline to 2, 4 and 8 weeks of treatment Post-randomization
Title
Change in itching based on Visual Analogue scale
Description
To evaluate change in itching based on Visual Analogue scale between three treatment arms, Visual Analogue scale (VAS) ranges from 0 to 10 (higher scores mean worse outcome)
Time Frame
Baseline to 2, 4 and 8 weeks of treatment Post-randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients (Non-pregnant) of plaque psoriasis aged 18 to 65 years having either Fitzpatrick skin type I-III or IV-VI.<br/>
Diagnosis of stable plaque psoriasis for 6 month by a dermatologist with lesions on arms, legs or trunk.
Mild to moderate psoriasis on Physician's global assessment (PGA),
Body Surface Area (BSA) involvement of 5-10% (both included) and PASI ≥ 5.
Patients must be willing to provide written informed consent and willing to comply with study requirements
Exclusion Criteria:
Predominantly palmo-plantar, flexural, scalp and nail location of psoriasis
Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis.
Patient with any uncontrolled systemic disease
Patient with positive serology tests like HIV, HCV & HBsAg.
Patient with presence of any skin disease that might interfere with the diagnosis or evaluation of the test medications.
Patient with spontaneously improving or rapidly deteriorating plaque psoriasis.
Use of systemic agents within four weeks prior to screening.
Use of biologic agents within four weeks prior to study entry.
Use of topical drugs that might alter the course of psoriasis or has received ultraviolet B treatment within two weeks prior to study entry.
Use of phototherapy with psoralen ultraviolet A treatment within four weeks prior to study entry.
Known sensitivity to any of the study treatments and/or study treatment's components.
Need for surgery or hospitalization during the study
Pregnant or nursing Female patient or planning a pregnancy
Concurrent involvement in any other clinical study within 30 days prior to entering the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Avhad, MBBS
Organizational Affiliation
Cadila Pharmaceuticals Limited
Official's Role
Study Director
Facility Information:
Facility Name
AC Subbareddy Government Hospital
City
Nellore
State/Province
Andhra Pradesh
ZIP/Postal Code
524004
Country
India
Facility Name
Downtown Hospital
City
Guwahati
State/Province
Assam
ZIP/Postal Code
781006
Country
India
Facility Name
Marwari Hospital & Research Centre
City
Guwahati
State/Province
Assam
ZIP/Postal Code
781008
Country
India
Facility Name
Sanjeevani CBCC USA Cancer Hospital
City
Raipur
State/Province
Chhattisgarh
ZIP/Postal Code
492001
Country
India
Facility Name
Kanoria Hospital & Research Centre
City
Gandhinagar
State/Province
Gujarat
ZIP/Postal Code
382428
Country
India
Facility Name
GMERS Medical College & Hospital
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390021
Country
India
Facility Name
Dhiraj General Hospital
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
391760
Country
India
Facility Name
KLES Dr. Prabhakar Kore Hospital & Medical Reserach Centre
City
Belgaum
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Facility Name
Government Medical College
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431001
Country
India
Facility Name
Gokuldas Tejpal Hospital Grant Government Medical College & Sir JJ Group of Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400001
Country
India
Facility Name
Dr. D.Y. Patil Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400706
Country
India
Facility Name
Midland Healthcare & Research Center
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226006
Country
India
Facility Name
Surya Super Speciality Hospital
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221010
Country
India
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial to Evaluate Efficacy and Safety of Two Different Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis
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