NCT05174598

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Cadila Pharnmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild to Moderate Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Calcipotriol/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.
DRUG	Calcipotriol Ointment 50 micrograms/g	Topical Ointment formulation containing Calcipotriol 50 micrograms/g. Twice daily treatment by applying on a psoriasis affected area for 8 weeks.
OTHER	Placebo	Topical spray formulation containing Vehicle of test formulation. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.

Timeline

• Start date: 2018-10-03
• Primary completion: 2019-11-06
• Completion: 2020-12-03
• First posted: 2022-01-03
• Last updated: 2022-03-03

Locations

14 sites across 1 country: India