MedTrace Logo

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

NCT05174598 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2022-03-03

No results posted yet for this study

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

Conditions

  • Mild to Moderate Plaque Psoriasis

Interventions

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.

Sponsors & Collaborators

  • Lipidor AB, Svärdvägen 13 SE-182 33 Danderyd, Sweden

    collaborator UNKNOWN

  • Cadila Pharnmaceuticals

    lead INDUSTRY

Principal Investigators

  • Anil Avhad, MBBS · Cadila Pharmaceuticals Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-03
Primary Completion
2019-11-06
Completion
2020-12-03

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05174598 on ClinicalTrials.gov