Clinical trial NCT05174598: A Clinical Trial to Evaluate Efficacy and Safety of Two Different Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mild to Moderate Plaque Psoriasis
Lead sponsor: Cadila Pharnmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Lipidor AB, Svärdvägen 13 SE-182 33 Danderyd, Sweden
First posted: 2022-01-03
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Psoriasis Area and Severity Index
timeFrame: Baseline to 8 weeks Post-randomization
Secondary outcomes:
measure: Assessment of Physician's Global Assessment (PGA)
timeFrame: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
measure: Incidence of Adverse Events and SAEs (Safety and Tolerability)
timeFrame: Till 8 weeks Post-randomization
measure: More than 50 % reduction in PASI Score (PASI 50)
timeFrame: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
measure: More than 75 % reduction in PASI Score (PASI 75)
timeFrame: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
measure: Change in Irritation based on Visual Analogue scale (VAS)
timeFrame: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
measure: Change in itching based on Visual Analogue scale
timeFrame: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
Other outcomes:
Locations:
city: Nellore
country: India
facility: AC Subbareddy Government Hospital
state: Andhra Pradesh
city: Guwahati
country: India
facility: Downtown Hospital
state: Assam
city: Guwahati
country: India
facility: Marwari Hospital & Research Centre
state: Assam
city: Raipur
country: India
facility: Sanjeevani CBCC USA Cancer Hospital
state: Chhattisgarh
city: Gandhinagar
country: India
facility: Kanoria Hospital & Research Centre
state: Gujarat
city: Vadodara
country: India
facility: GMERS Medical College & Hospital
state: Gujarat
city: Vadodara
country: India
facility: Dhiraj General Hospital
state: Gujarat
city: Belgaum
country: India
facility: KLES Dr. Prabhakar Kore Hospital & Medical Reserach Centre
state: Karnataka
city: Aurangabad
country: India
facility: Government Medical College
state: Maharashtra
city: Mumbai
country: India
facility: Gokuldas Tejpal Hospital Grant Government Medical College & Sir JJ Group of Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Dr. D.Y. Patil Hospital
state: Maharashtra
city: Lucknow
country: India
facility: Midland Healthcare & Research Center
state: Uttar Pradesh
city: Varanasi
country: India
facility: Surya Super Speciality Hospital
state: Uttar Pradesh
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
affiliation: Cadila Pharmaceuticals Limited
name: Anil Avhad, MBBS
role: STUDY_DIRECTOR
References: