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Clinical Study to evaluate the Efficacy and Safety of MEZO cream with ELOCON Cream in the treatment of plaque psoriasis

A Prospective Interventional Randomized Parallel Double blind Comparative Clinical Study to evaluate the Efficacy and Safety of MEZO cream 0.1 % (Mometasone Furoate USP 0.1%) with ELOCON Cream 0.1% (Mometasone Furoate 0.1%) in the treatment of plaque psoriasis - ICBio-CR-APL-0620-95

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/021908
Enrollment
60
Registered
2019-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L00- Staphylococcal scalded skin syndrome

Interventions

Intervention1: MEZO cream: Mometasone Furoate USP 0.1% w/w Method of application A thin film of Mometasone Furoate USP 0.1 % Cream should be applied to the affected areas of skin once daily One finge

Sponsors

AGIO PHARMACEUTICALS LTD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults of both sexes Age 18 or older with good mental health Psoriasis patients with mild to moderate as classified by investigator based on body surface area Mild to moderate psoriasis means that the red scaly patches plaques cover less than 10 percent of your body Subject who in the opinion of the investigator are free of any medical condition s that may interfere with study participation or affect study measures Willing to provide written informed consent for participation in the study and adhere to the protocol requirements Patients who agreed to return for follow-up visits

Exclusion criteria

Exclusion criteria: Patients who are not willing to give written informed consent Patients who also had psoriatic plaques of skin disorders caused by fungi or bacteria and they were making use of antibiotic or antifungal Other types of skin damage that was not psoriasis Pregnant and nursing women Patients using oral anticoagulants Any finding of clinical observation that is interpreted by the investigator as a risk to the patients participation in the study 7. Severely immune compromised patients Use of any investigational drug currently or within 30 days prior to study entry Subjects on any prescription medication that might interfere with study outcomes History of alcohol or drug abuse Patients having Impetigo cellulitis lymphangitis

Design outcomes

Primary

MeasureTime frame
To assess the improvement in psoriatic sign and symptoms using a scale Parameters will be evaluated for erythema plaque size Scaling itching thickness of the lesionTimepoint: baseline EOT

Secondary

MeasureTime frame
Self Assessment of General Health Tolerance To evaluate the quality of life Assessment of safety of the Investigational products Adverse event Physical examination Biomarker of systemic safety Hematological test Liver function test Renal function test Serum creatinine RBS Timepoint: baseline to EOT

Countries

India

Contacts

Public ContactDr Harisha S

ICBio Clinical Research Pvt Ltd

harish@icbiocro.com09900111997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026