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

Phase 3

Completed

• Conditions: Staphylococcal scalded skin syndrome,

• Registration Number: CTRI/2019/11/021908
• Lead Sponsor: AGIO PHARMACEUTICALS LTD

Brief Summary

“A Prospective, Interventional, Randomized, Parallel, Double blind, Comparative, Clinical Study to evaluate the Efficacy & 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.’’

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|Total of  60 subjects

Test: - 30 subjects [MEZO cream 0.1% (Mometasone Furoate USP 0.1%)]

Reference: - 30 subjects [ELOCON®cream 0.1% (Mometasone Furoate 0.1%)]

-Male and Female subjects having age 18 and above will be enrolled in the study.

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|-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% of your body]

The study duration is 72 days (Around 10 weeks (6 weeks treatment plus follow up after 1 month))

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-11
• Study Completion: 2020-06-15
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the improvement in psoriatic sign and symptoms using a scale	baseline EOT
Parameters will be evaluated for erythema plaque size Scaling itching thickness of the lesion	baseline EOT

Secondary Outcome Measures

Name	Time	Method
Self Assessment of General Health	Tolerance

Trial Locations

Locations (1)

The Skin Artistry; 🇮🇳 Ahmadabad, GUJARAT, India

The Skin Artistry

🇮🇳Ahmadabad, GUJARAT, India

Dr Hitalkumar Patel

Principal investigator

9824601777

H.R.Patel@Doctor.com