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

Phase 3

Completed

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

• Registration Number: NCT05174598
• Lead Sponsor: Cadila Pharnmaceuticals

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.

Study Timeline

• Study Start: 2018-10-03
• Primary Completion: 2019-11-06
• Study Completion: 2020-12-03
• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-03
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcipotriol/AKVANO, 50 μg/g cutaneous solution	Calcipotriol/AKVANO, 50 μg/g cutaneous solution	Spray formulation applied topically, twice daily, for the duration of 8 weeks.
Calcipotriol Ointment 50 micrograms/g, Sandoz	Calcipotriol Ointment 50 micrograms/g	Ointment applied topically, twice daily, for the duration of 8 weeks.
Placebo	Placebo	Spray formulation applied topically, twice daily, for the duration of 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Psoriasis Area and Severity Index	Baseline to 8 weeks Post-randomization	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

Name	Time	Method
More than 50 % reduction in PASI Score (PASI 50)	Baseline to 2, 4 and 8 weeks of treatment Post-randomization	Proportion of patients achieving \>50 % reduction in PASI Score (PASI50) with Test and comparator
More than 75 % reduction in PASI Score (PASI 75)	Baseline to 2, 4 and 8 weeks of treatment Post-randomization	Proportion of patients achieving \>75 % reduction in PASI Score (PASI75) with Test and comparator.
Change in Irritation based on Visual Analogue scale (VAS)	Baseline to 2, 4 and 8 weeks of treatment Post-randomization	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	Baseline to 2, 4 and 8 weeks of treatment Post-randomization	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)
Incidence of Adverse Events and SAEs (Safety and Tolerability)	Till 8 weeks Post-randomization	Incidence of Adverse Event and Serious Adverse Event between three treatment arms
Assessment of Physician's Global Assessment (PGA)	Baseline to 2, 4 and 8 weeks of treatment Post-randomization	Proportion of patients achieving PGA 0 or 1 with Test and comparator

Trial Locations

Locations (14)

Midland Healthcare & Research Center; 🇮🇳 Lucknow, Uttar Pradesh, India

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India

Government Medical College; 🇮🇳 Aurangabad, Maharashtra, India

Sanjeevani CBCC USA Cancer Hospital; 🇮🇳 Raipur, Chhattisgarh, India

AC Subbareddy Government Hospital; 🇮🇳 Nellore, Andhra Pradesh, India

Downtown Hospital; 🇮🇳 Guwahati, Assam, India

Marwari Hospital & Research Centre; 🇮🇳 Guwahati, Assam, India

Kanoria Hospital & Research Centre; 🇮🇳 Gandhinagar, Gujarat, India

GMERS Medical College & Hospital; 🇮🇳 Vadodara, Gujarat, India

Dhiraj General Hospital; 🇮🇳 Vadodara, Gujarat, India

Dr. D.Y. Patil Hospital; 🇮🇳 Mumbai, Maharashtra, India

Gokuldas Tejpal Hospital Grant Government Medical College & Sir JJ Group of Hospital; 🇮🇳 Mumbai, Maharashtra, India

Surya Super Speciality Hospital; 🇮🇳 Varanasi, Uttar Pradesh, India

KLES Dr. Prabhakar Kore Hospital & Medical Reserach Centre; 🇮🇳 Belgaum, Karnataka, India