Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Tacrolimus 0.1% Topical Ointment by Intas Pharmaceuticals Ltd.,: Dose-1 cm ribbon spread over approx. 100 cm2 skin surface,Frequency-Twice daily,Mode of Administration-Topical,Duration
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 70 years of age (both inclusive) 2. Patients with a diagnosis of atopic dermatitis for at least 3 months 3. Patient with affected area of AD involvement at least 20% body surface area (BSA) 4. Patients with disease severity of grading moderate to severe AD (i.e. a score of 3 or 4) as defined by the scoring system IGA of disease severity 5. Patient treated with bland emollient for at least 7 days prior to randomization 6. Both male and female patients of child bearing potential must be practicing adequate contraception and female patients of childbearing potential must not be/likely to be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization 7. Patient is capable of understanding the purposes and risks of the trial and has given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form 8. Patient has not taken and agrees not to take any medication or therapy prohibited by the protocol for the entire study period
Exclusion criteria
Exclusion criteria: 1. Newly diagnosed or treatment naive patients 2. Patients with very severe atopic dermatitis requiring systemic therapy for AD 3. Patient with active cutaneous bacterial or viral infection in any treatment area at baseline 4. History of allergy or hypersensitivity to tacrolimus or any other component of the test product or RLD 5. Patient not willing to minimize or avoid natural and artificial sunlight exposure during treatment 6. Patient with confounding skin conditions 7. Patients with diagnosed renal and hepatic failure 8. Positive Urine drug scan at screening visit for drugs likely to cause abuse 9. Simultaneous participation in any other clinical study 10. Clinically significant laboratory test results or any other condition
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To evaluate the safety profiles of both ointments and to compare their systemic absorption at steady state.Timepoint: At the end of study | — |
Primary
| Measure | Time frame |
|---|---|
| â?¢ To establish the therapeutic equivalence between tacrolimus ointment 0.1%, manufactured by Intas Pharmaceuticals Ltd., India and Protopic® (tacrolimus), 0.1% topical ointment manufactured by Astellas Pharma US, Inc.Timepoint: At the end of study | — |
Countries
India
Contacts
Public ContactDr Falgun Vyas
Lambda Therapeutic Research Ltd.
Outcome results
None listed