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| Name | Class |
|---|---|
| Lipidor AB, Svärdvägen 13 SE-182 33 Danderyd, Sweden | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcipotriol/AKVANO, 50 μg/g cutaneous solution | Experimental | Spray formulation applied topically, twice daily, for the duration of 8 weeks. |
|
| Calcipotriol Ointment 50 micrograms/g, Sandoz | Active Comparator | Ointment applied topically, twice daily, for the duration of 8 weeks. |
|
| Placebo | Placebo Comparator | Spray formulation applied topically, twice daily, for the duration of 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriol/AKVANO, 50 μg/g cutaneous solution | Drug | Topical spray formulation containing Calcipotriol 50 μg/g. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anil Avhad, MBBS | Cadila Pharmaceuticals Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AC Subbareddy Government Hospital | Nellore | Andhra Pradesh | 524004 | India | ||
| Downtown Hospital |
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| Calcipotriol Ointment 50 micrograms/g | Drug | Topical Ointment formulation containing Calcipotriol 50 micrograms/g. Twice daily treatment by applying on a psoriasis affected area for 8 weeks. |
|
| Placebo | Other | Topical spray formulation containing Vehicle of test formulation. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks. |
|
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 |
| Guwahati |
| Assam |
| 781006 |
| India |
| Marwari Hospital & Research Centre | Guwahati | Assam | 781008 | India |
| Sanjeevani CBCC USA Cancer Hospital | Raipur | Chhattisgarh | 492001 | India |
| Kanoria Hospital & Research Centre | Gandhinagar | Gujarat | 382428 | India |
| GMERS Medical College & Hospital | Vadodara | Gujarat | 390021 | India |
| Dhiraj General Hospital | Vadodara | Gujarat | 391760 | India |
| KLES Dr. Prabhakar Kore Hospital & Medical Reserach Centre | Belagavi | Karnataka | 590010 | India |
| Government Medical College | Aurangabad | Maharashtra | 431001 | India |
| Gokuldas Tejpal Hospital Grant Government Medical College & Sir JJ Group of Hospital | Mumbai | Maharashtra | 400001 | India |
| Dr. D.Y. Patil Hospital | Mumbai | Maharashtra | 400706 | India |
| Midland Healthcare & Research Center | Lucknow | Uttar Pradesh | 226006 | India |
| Surya Super Speciality Hospital | Varanasi | Uttar Pradesh | 221010 | India |
| Postgraduate Institute of Medical Education and Research | Chandigarh | 160012 | India |
| ID | Term |
|---|---|
| C055085 | calcipotriene |
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