A three arm study Compare Efficacy and Safety Evaluation of Tacrolimus 0.1% Topical Ointment Formulations in atopic dermatitis .
- Conditions
- Health Condition 1: L209- Atopic dermatitis, unspecified
- Registration Number
- CTRI/2011/07/001878
- Lead Sponsor
- Intas Pharmaceuticals Ltd Ahmedabad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 76
1.Male or non-pregnant, non-lactating female of any ethnic group, 18 ? 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, or when those treatments are not advisable. [19]
5.Both male and female patients of child bearing potential must be practicing adequate contraception and female patients of child-bearing 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.
6.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.
7.Patient has not taken and agrees not to take any medication or therapy prohibited by the protocol for the entire study period.
1.Newly diagnosed patients.
2.Patients with very severe atopic dermatitis requiring systemic therapy for AD.
3.Clinically infected atopic dermatitis at the baseline visit.
4.Any dermatological condition other than atopic dermatitis as scar/wound/tattoo at the application site or in its close vicinity that in the investigators opinion may interfere with the evaluation of the patients atopic dermatitis.
5.Patient who have not had a minimum washout phase (prior to randomization) as follows:
?5 days: medicated topical agents, systemic antihistamines and sedatives
?7 days : intranasal or inhaled corticosteroids employed 1 mg/day
?4 weeks: systemic corticosteroids and nonsteroidal immunosuppressants
?6 weeks: UV treatments
6.History of allergy or hypersensitivity to tacrolimus or any of the ointment excipients, pimecrolimus, any macrolides such as clindamycin, erythromycin, azithromycin, clarithyromycin etc.
7.History or known case of congenital or acquired immunodeficiencies, which in the investigator?s opinion would contraindicate the use of immunosuppressants, including but not limited to human immunodeficiency virus (HIV) infection and cancer.
8.Patient with a known case of genetic epidermal barrier defect such as Netherton?s syndrome or generalised erythroderma.
9. Patients with a known case of Cushing?s syndrome.
10. Patients with diagnosed hepatic failure:
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to assess the therapeutic response of two test formulations and a reference formulation of tacrolimus 0.1%.Timepoint: The primary objective is to assess the therapeutic response of two test formulations and a reference formulation of tacrolimus 0.1%.
- Secondary Outcome Measures
Name Time Method The secondary objectives are to describe the safety profile of the three ointments and to investigate their systemic absorption at steady state.Timepoint: NI