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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
278
Topical spray formulation containing Calcipotriol 50 μg/g. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.
Topical Ointment formulation containing Calcipotriol 50 micrograms/g. Twice daily treatment by applying on a psoriasis affected area for 8 weeks.
Topical spray formulation containing Vehicle of test formulation. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.
AC Subbareddy Government Hospital
Nellore, Andhra Pradesh, India
Downtown Hospital
Guwahati, Assam, India
Marwari Hospital & Research Centre
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)
Time frame: Baseline to 8 weeks Post-randomization
Assessment of Physician's Global Assessment (PGA)
Proportion of patients achieving PGA 0 or 1 with Test and comparator
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
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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
...and 4 more locations
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)
Time frame: Baseline to 2, 4 and 8 weeks of treatment Post-randomization