Study to evaluate the Efficacy, Safety and Tolerability of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in Patients with Inflammatory Lesions of Rosacea.

Phase 3

Active, not recruiting

• Conditions: Local infection of the skin and subcutaneous tissue, unspecified,

• Registration Number: CTRI/2017/02/007835
• Lead Sponsor: Ajanta Pharma Limited

Brief Summary

This clinical trial is a Comparative,Randomized, Two Arm, Multicentric, Active Controlled, Open label, ParallelGroup, Phase III Study to Evaluate the Efficacy, Safety and Tolerability ofIvermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in Patients withInflammatory Lesions of Rosacea. The duration of clinical trial is 85 days foreach patient. The primary outcome of the study is to measure Mean change in theIGA Score from baseline to Day 85. Safety parameter includes Percentage ofpatients reporting AE and/or SAE during the study, its frequency, severity,pattern and causal relationship to the drug and Local Tolerance Parameters(Stinging/burning, dryness and itching) at each visit evaluated on 4-pointscale [from 0 to 3 Severe].

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-14
• Last Update Posted: 2018-11-24

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 1. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. 2. Patients diagnosed with inflammatory lesions of papulopustular rosacea only in central area of the face, T zone and chin with a score of 2.
• 4 according to Investigator Global Assessment (IGA). 3. Subjects who would be able to follow the protocol schedules. 4. Free of any clinically significant disease which can potentially interfere with the study.

Exclusion Criteria

• 1.Subjects known to be non-responders to Azelaic Acid.
• 2.Subjects with any bleeding disorders.
• 3.Subjects with comedogenic and non comedogenic papules and pustules of acne vulgaris.
• 4.Subjects with particular forms of rosacea (rosacea conglobate, rosacea fulminant, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis or seborrheic dermatitis and acne.
• 5.Subjects with rosacea with more than two nodules on the face.
• 6.Subjects on treatment of Oral Isotretinoin within 6 months.
• 7.History of any skin diseases and/or ongoing treatment for any other skin related disorder.
• 8.Any acute and/or chronic systemic disorders which is uncontrolled within last one month (cardiovascular, renal, hepatic, respiratory, gastrointestinal, central nervous system, endocrine).
• 9.Pregnant or nursing (lactating) women or women with child bearing potential who are not taking acceptable form of contraceptive.
• 10.Known or suspected hypersensitivity to any drug that will be administered during the study.
• 11.Inability to comply with the protocol requirements.
• 12.Participation in any other clinical trial within 3 months of registering in this trial.
• 13.Medical history of oncological disease within 5 years before screening.
• 14.Patients with infections of HIV, hepatitis B or C.
• 15.Patients with history of wasting disease, autoimmune disease, connective tissue disease or History of drug or alcohol abuse within the previous 2 years.
• 16.Any condition or therapy that in the opinion of the Investigator may pose a risk to the subject or interfere with the evaluation of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•To evaluate the efficacy of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in patients with inflammatory lesions of Rosacea.	•To evaluate the efficacy of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in patients with inflammatory lesions of Rosacea.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and Tolerability of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in patients with inflammatory lesions of Rosacea.	•To evaluate the tolerability of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in patients with inflammatory lesions of Rosacea.

Trial Locations

Locations (10)

Ajanta Hospital; 🇮🇳 Lucknow, UTTAR PRADESH, India

B.J. Medical College & Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

BYL Nair Hospital & TNMC; 🇮🇳 Mumbai, MAHARASHTRA, India

Father Muller Medical College Hospital; 🇮🇳 Kannada, KARNATAKA, India

Grant Govt. Medical College & Sir J.J Groups of Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Indira Gandhi Institute of Medical Sciences; 🇮🇳 Patna, BIHAR, India

Maharaja Agrasen Hospital; 🇮🇳 Delhi, DELHI, India

Maulana Azad Medical College; 🇮🇳 Central, DELHI, India

Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Sterling Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Ajanta Hospital

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Shatrughan Sahay

Principal investigator

09412119129

dr.shatru@yahoo.com