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

Last updated: February 15, 2022
Sponsor: Cadila Pharnmaceuticals
Overall Status: Completed

Phase

3

Condition

Warts

Scalp Disorders

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT05174598
CRSC16004
  • Ages 18-65
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female patients (Non-pregnant) of plaque psoriasis aged 18 to 65 years havingeither Fitzpatrick skin type I-III or IV-VI.<br/>
  • Diagnosis of stable plaque psoriasis for 6 month by a dermatologist with lesions onarms, 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 complywith study requirements

Exclusion

Exclusion Criteria:

  • Predominantly palmo-plantar, flexural, scalp and nail location of psoriasis
  • Guttate, erythrodermic, or pustular psoriasis as sole or predominant form ofpsoriasis.
  • 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 orevaluation 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 receivedultraviolet B treatment within two weeks prior to study entry.
  • Use of phototherapy with psoralen ultraviolet A treatment within four weeks prior tostudy 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 enteringthe study

Study Design

Total Participants: 278
Study Start date:
October 03, 2018
Estimated Completion Date:
December 03, 2020

Study 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.

Connect with a study center

  • AC Subbareddy Government Hospital

    Nellore, Andhra Pradesh 524004
    India

    Site Not Available

  • Downtown Hospital

    Guwahati, Assam 781006
    India

    Site Not Available

  • Marwari Hospital & Research Centre

    Guwahati, Assam 781008
    India

    Site Not Available

  • Sanjeevani CBCC USA Cancer Hospital

    Raipur, Chhattisgarh 492001
    India

    Site Not Available

  • Kanoria Hospital & Research Centre

    Gandhinagar, Gujarat 382428
    India

    Site Not Available

  • Dhiraj General Hospital

    Vadodara, Gujarat 391760
    India

    Site Not Available

  • GMERS Medical College & Hospital

    Vadodara, Gujarat 390021
    India

    Site Not Available

  • KLES Dr. Prabhakar Kore Hospital & Medical Reserach Centre

    Belgaum, Karnataka 590010
    India

    Site Not Available

  • Government Medical College

    Aurangabad, Maharashtra 431001
    India

    Site Not Available

  • Dr. D.Y. Patil Hospital

    Mumbai, Maharashtra 400706
    India

    Site Not Available

  • Gokuldas Tejpal Hospital Grant Government Medical College & Sir JJ Group of Hospital

    Mumbai, Maharashtra 400001
    India

    Site Not Available

  • Midland Healthcare & Research Center

    Lucknow, Uttar Pradesh 226006
    India

    Site Not Available

  • Surya Super Speciality Hospital

    Varanasi, Uttar Pradesh 221010
    India

    Site Not Available

  • Postgraduate Institute of Medical Education and Research

    Chandigarh, 160012
    India

    Site Not Available

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