A Clinical Trial to Evaluate Efficacy and Safety of Two Different Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis (AKP01)

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

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

Study Overview

• Status: Completed
• Conditions: Mild to Moderate Plaque Psoriasis
• Intervention / Treatment: Drug: Calcipotriol/AKVANO, 50 μg/g cutaneous solution; Drug: Calcipotriol Ointment 50 micrograms/g; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Postgraduate Institute of Medical Education and Research
  • Andhra Pradesh
    • Nellore, Andhra Pradesh, India, 524004
      • AC Subbareddy Government Hospital
  • Assam
    • Guwahati, Assam, India, 781006
      • Downtown Hospital
    • Guwahati, Assam, India, 781008
      • Marwari Hospital & Research Centre
  • Chhattisgarh
    • Raipur, Chhattisgarh, India, 492001
      • Sanjeevani CBCC USA Cancer Hospital
  • Gujarat
    • Gandhinagar, Gujarat, India, 382428
      • Kanoria Hospital & Research Centre
    • Vadodara, Gujarat, India, 391760
      • Dhiraj General Hospital
    • Vadodara, Gujarat, India, 390021
      • GMERS Medical College & Hospital
  • Karnataka
    • Belgaum, Karnataka, India, 590010
      • KLES Dr. Prabhakar Kore Hospital & Medical Reserach Centre
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431001
      • Government Medical College
    • Mumbai, Maharashtra, India, 400001
      • Gokuldas Tejpal Hospital Grant Government Medical College & Sir JJ Group of Hospital
    • Mumbai, Maharashtra, India, 400706
      • Dr. D.Y. Patil Hospital
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226006
      • Midland Healthcare & Research Center
    • Varanasi, Uttar Pradesh, India, 221010
      • Surya Super Speciality Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
  
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Calcipotriol/AKVANO, 50 μg/g cutaneous solution; Spray formulation applied topically, twice daily, for the duration of 8 weeks.	Drug: Calcipotriol/AKVANO, 50 μg/g cutaneous solution; Topical spray formulation containing Calcipotriol 50 μg/g. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.
Active Comparator: Calcipotriol Ointment 50 micrograms/g, Sandoz; Ointment applied topically, twice daily, for the duration of 8 weeks.	Drug: Calcipotriol Ointment 50 micrograms/g; Topical Ointment formulation containing Calcipotriol 50 micrograms/g. Twice daily treatment by applying on a psoriasis affected area for 8 weeks.
Placebo Comparator: Placebo; Spray formulation applied topically, twice daily, for the duration of 8 weeks.	Other: Placebo; Topical spray formulation containing Vehicle of test formulation. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline to 8 weeks Post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Physician's Global Assessment (PGA)	Proportion of patients achieving PGA 0 or 1 with Test and comparator	Baseline to 2, 4 and 8 weeks of treatment Post-randomization
Incidence of Adverse Events and SAEs (Safety and Tolerability)	Incidence of Adverse Event and Serious Adverse Event between three treatment arms	Till 8 weeks Post-randomization
More than 50 % reduction in PASI Score (PASI 50)	Proportion of patients achieving >50 % reduction in PASI Score (PASI50) with Test and comparator	Baseline to 2, 4 and 8 weeks of treatment Post-randomization
More than 75 % reduction in PASI Score (PASI 75)	Proportion of patients achieving >75 % reduction in PASI Score (PASI75) with Test and comparator.	Baseline to 2, 4 and 8 weeks of treatment Post-randomization
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)	Baseline to 2, 4 and 8 weeks of treatment Post-randomization
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)	Baseline to 2, 4 and 8 weeks of treatment Post-randomization

Collaborators and Investigators

• Sponsor: Cadila Pharnmaceuticals
• Collaborators: Lipidor AB, Svärdvägen 13 SE-182 33 Danderyd, Sweden
• Investigators: Study Director: Anil Avhad, MBBS, Cadila Pharmaceuticals Limited

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2018
• Primary Completion (Actual): November 6, 2019
• Study Completion (Actual): December 3, 2020

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Calcipotriene; Calcitriol
• Other Study ID Numbers: CRSC16004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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