Mild to Moderate Plaque Psoriasis
Conditions
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.
Interventions
DRUGCalcipotriol/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.
Topical Ointment formulation containing Calcipotriol 50 micrograms/g. Twice daily treatment by applying on a psoriasis affected area for 8 weeks.
OTHERPlacebo
Topical spray formulation containing Vehicle of test formulation. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.
Sponsors
Lipidor AB, Svärdvägen 13 SE-182 33 Danderyd, Sweden
Cadila Pharnmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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) |
| 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. |
Countries
India
Outcome results
None listed