A Clinical Trial to Evaluate Efficacy and Safety of Two Different Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis (AKP01)

Cadila Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Mild to Moderate Plaque Psoriasis

Treatments: Other: Placebo; Drug: Calcipotriol Ointment 50 micrograms/g; Drug: Calcipotriol/AKVANO, 50 μg/g cutaneous solution

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05174598

CRSC16004

Details and patient eligibility

About

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

Full 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.

Enrollment: 278 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.<br/>
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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278 participants in 3 patient groups, including a placebo group

Calcipotriol/AKVANO, 50 μg/g cutaneous solution

Experimental group

Description:

Spray formulation applied topically, twice daily, for the duration of 8 weeks.

Treatment:

Drug: Calcipotriol/AKVANO, 50 μg/g cutaneous solution

Calcipotriol Ointment 50 micrograms/g, Sandoz

Active Comparator group

Description:

Ointment applied topically, twice daily, for the duration of 8 weeks.

Treatment:

Drug: Calcipotriol Ointment 50 micrograms/g

Placebo

Placebo Comparator group

Description:

Spray formulation applied topically, twice daily, for the duration of 8 weeks.

Treatment:

Other: Placebo