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

NCT05174598 | Completed Phase 3

• 1 other identifier: CRSC16004
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 14

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

Conditions

Mild to Moderate Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Assessment of Physician's Global Assessment (PGA)

  Baseline to 2, 4 and 8 weeks of treatment Post-randomization

• Incidence of Adverse Events and SAEs (Safety and Tolerability)

  Till 8 weeks Post-randomization

• More than 50 % reduction in PASI Score (PASI 50)

  Baseline to 2, 4 and 8 weeks of treatment Post-randomization

• More than 75 % reduction in PASI Score (PASI 75)

  Baseline to 2, 4 and 8 weeks of treatment Post-randomization

• Change in Irritation based on Visual Analogue scale (VAS)

  Baseline to 2, 4 and 8 weeks of treatment Post-randomization

Study Arms (3)

Calcipotriol/AKVANO, 50 μg/g cutaneous solution

EXPERIMENTAL

Spray formulation applied topically, twice daily, for the duration of 8 weeks.

Drug: Calcipotriol/AKVANO, 50 μg/g cutaneous solution

Calcipotriol Ointment 50 micrograms/g, Sandoz

ACTIVE COMPARATOR

Ointment applied topically, twice daily, for the duration of 8 weeks.

Drug: Calcipotriol Ointment 50 micrograms/g

Placebo

PLACEBO COMPARATOR

Spray formulation applied topically, twice daily, for the duration of 8 weeks.

Other: Placebo

Interventions

Calcipotriol/AKVANO, 50 μg/g cutaneous solution DRUG

Topical spray formulation containing Calcipotriol 50 μg/g. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.

Calcipotriol/AKVANO, 50 μg/g cutaneous solution

Calcipotriol Ointment 50 micrograms/g DRUG

Topical Ointment formulation containing Calcipotriol 50 micrograms/g. Twice daily treatment by applying on a psoriasis affected area for 8 weeks.

Calcipotriol Ointment 50 micrograms/g, Sandoz

Placebo OTHER

Topical spray formulation containing Vehicle of test formulation. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cadila Pharnmaceuticals: lead
• Lipidor AB, Svärdvägen 13 SE-182 33 Danderyd, Sweden: collaborator

Study Sites (14)

AC Subbareddy Government Hospital

Nellore, Andhra Pradesh, 524004, India

Location

Downtown Hospital

Guwahati, Assam, 781006, India

Location

Marwari Hospital & Research Centre

Guwahati, Assam, 781008, India

Location

Sanjeevani CBCC USA Cancer Hospital

Raipur, Chhattisgarh, 492001, India

Location

Kanoria Hospital & Research Centre

Gandhinagar, Gujarat, 382428, India

Location

GMERS Medical College & Hospital

Vadodara, Gujarat, 390021, India

Location

Dhiraj General Hospital

Vadodara, Gujarat, 391760, India

Location

KLES Dr. Prabhakar Kore Hospital & Medical Reserach Centre

Belagavi, Karnataka, 590010, India

Location

Government Medical College

Aurangabad, Maharashtra, 431001, India

Location

Gokuldas Tejpal Hospital Grant Government Medical College & Sir JJ Group of Hospital

Mumbai, Maharashtra, 400001, India

Location

Dr. D.Y. Patil Hospital

Mumbai, Maharashtra, 400706, India

Location

Midland Healthcare & Research Center

Lucknow, Uttar Pradesh, 226006, India

Location

Surya Super Speciality Hospital

Varanasi, Uttar Pradesh, 221010, India

Location

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

MeSH Terms

Interventions

calcipotriene

Study Officials

• Anil Avhad, MBBS

  Cadila Pharmaceuticals Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 3, 2022
• Study Start: October 3, 2018
• Primary Completion: November 6, 2019
• Study Completion: December 3, 2020
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (14)