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

NCT ID: NCT05174598

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-03
• Study Completion Date: 2020-12-03

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.

Conditions

Mild to Moderate Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Calcipotriol/AKVANO, 50 μg/g cutaneous solution

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

Group Type: EXPERIMENTAL

Calcipotriol/AKVANO, 50 μg/g cutaneous solution

Intervention Type: DRUG

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

Calcipotriol Ointment 50 micrograms/g, Sandoz

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

Group Type: ACTIVE_COMPARATOR

Calcipotriol Ointment 50 micrograms/g

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lipidor AB, Svärdvägen 13 SE-182 33 Danderyd, Sweden

UNKNOWN

Sponsor Role: collaborator

Cadila Pharnmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anil Avhad, MBBS

Role: STUDY_DIRECTOR

Cadila Pharmaceuticals Limited

Locations

AC Subbareddy Government Hospital

Nellore, Andhra Pradesh, India

Downtown Hospital

Guwahati, Assam, India

Marwari Hospital & Research Centre

Guwahati, Assam, India

Sanjeevani CBCC USA Cancer Hospital

Raipur, Chhattisgarh, India

Kanoria Hospital & Research Centre

Gandhinagar, Gujarat, India

GMERS Medical College & Hospital

Vadodara, Gujarat, India

Dhiraj General Hospital

Vadodara, Gujarat, India

KLES Dr. Prabhakar Kore Hospital & Medical Reserach Centre

Belagavi, Karnataka, India

Government Medical College

Aurangabad, Maharashtra, India

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

Mumbai, Maharashtra, India

Dr. D.Y. Patil Hospital

Mumbai, Maharashtra, India

Midland Healthcare & Research Center

Lucknow, Uttar Pradesh, India

Surya Super Speciality Hospital

Varanasi, Uttar Pradesh, India

Postgraduate Institute of Medical Education and Research

Chandigarh, , India

Countries

India

Other Identifiers

CRSC16004

Identifier Type: -

Identifier Source: org_study_id