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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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
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Mild to Moderate Plaque Psoriasis

Intervention / Treatment
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* Drug: Calcipotriol/AKVANO, 50 μg/g cutaneous solution
* Drug: Calcipotriol Ointment 50 micrograms/g
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |