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

• Status: Completed
• Trial end date: 2020-12-03
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cadila Pharnmaceuticals
• Collaborator: Lipidor AB, Svärdvägen 13 SE-182 33 Danderyd, Sweden
• Treatments: Calcipotriene; Calcitriol

Criteria

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.

• 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