Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Tacrolimus Monohydrate Ointment 0.1%: Applied as a thin layer to all affected areas (1 cm ribbon spread is recommended over approx. 100 cm2 skin surface) twice daily for 6 weeks (End
Sponsors
Accord Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female of any ethnic group, 18 â?? 70 years of age (both inclusive) at the time of signing the informed consent. 2. Patients having atopic dermatitis according to Hanifin and Rajka diagnostic criteria (Appendix I). 3. Patients with a grading of moderate to severe AD (i.e. a score of at least 4.5) as defined by the scoring system of Rajka and Langeland (Appendix II). 4. Non-immunocompromised adults who have failed to respond adequately to other topical prescription treatments for AD, or when those treatments are not advisable in the opinion of the Investigator. 5. Last application of medicated topical agents, intake of systemic antihistamines, intranasal or inhaled corticosteroids ( > 1 mg/day) should be minimum 7 days prior to randomization. 6. Last application of tacrolimus ointment, intake of systemic corticosteroids and nonsteroidal immunosuppressants should be minimum 3 weeks prior to randomization.
Exclusion criteria
Exclusion criteria: 1. Newly diagnosed or Treatment naïve patients 2. Patients with mild (Rajka and Langeland score of 1. Patients in need of undergoing UV treatments for AD. 2. Clinically infected atopic dermatitis at the baseline visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Eczema Area and Severity Index (EASI) scoreTimepoint: Day 0, Day 4. day 7, day 14, day 21, Day 28, day 28, day 42 and day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with â?¥ 60% improvement on EASI total scoreTimepoint: Week 6 / End of Treatment (EOT) Visit;2. Change in grading of AD as defined by the scoring system of Rajka and Langeland from baselineTimepoint: at Week 6 / End of Treatment (EOT) Visit;3. Percentage of body surface area affected (% BSA affected)Timepoint: Week 6 / End of Treatment (EOT) Visit;4.Physicianâ??s Assessment of Individual Signs of Atopic DermatitisTimepoint: Week 6 / End of Treatment (EOT) Visit;5.Patientâ??s Assessment of PruritusTimepoint: week 6/ End of Treatment (EOT) | — |
Countries
India, Poland
Contacts
Public ContactDr Randhirsingh Solanki
Lambda Therapeutic Research Ltd.
Outcome results
None listed