Health Condition 1: null- Inflammatory Lesions of Rosacea Health Condition 2: L089- Local infection of the skin and subcutaneous tissue, unspecified
Conditions
Interventions
Intervention1: Ivermectin Cream 1% w/w: Apply cream topically on affected areas once Daily every possibly at the same time everyday for 85 days.
Total duration of Therapy is 85 Days.
Control Interven
Sponsors
Ajanta Pharma Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To evaluate the efficacy of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in patients with inflammatory lesions of Rosacea.Timepoint: â?¢ 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
| Measure | Time frame |
|---|---|
| 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. â?¢ To evaluate the tolerability of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in patients with inflammatory lesions of Rosacea.Timepoint: â?¢ Percentage of patients reporting AE and/or SAE during the study, its frequency, severity, pattern and causal relationship to the drug. â?¢ Local Tolerance Parameters (Stinging/burning, dryness and itching) at each visit evaluated on 4-point scale [from 0 to 3 Severe]. | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd
Outcome results
None listed