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A Phase III Study in Subjects With Mild to Moderate Psoriasis.

NCT05249972 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2022-08-10

No results posted yet for this study

Summary

A randomized, assessor blind, parallel group, three arms, active and placebo controlled study with objective to demonstrate therapeutic non-inferiority of AKP02 cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) versus Enstilar cutaneous foam (calcipotriol 50 μg/g + betamethasone 0.5 mg/g) in subjects with mild to moderate plaque psoriasis.

Conditions

  • Mild to Moderate Psoriasis

Interventions

DRUG

AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO)

Topical cutaneous spray

DRUG

Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g)

Topical foam

OTHER

Placebo

Placebo cutaneous spray

Sponsors & Collaborators

  • Lipidor AB

    lead INDUSTRY

Principal Investigators

  • Maria Klockare, PhD · Lipidor AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-24
Primary Completion
2022-08-11
Completion
2022-08-18

Countries

  • India

Study Locations

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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 NCT05249972 on ClinicalTrials.gov