A randomized, double-blind, Placebo-controlled, three arms, parallel-group, multiple-site bioequivalence study with clinical endpoints
- Conditions
- Health Condition 1: L209- Atopic dermatitis, unspecified
- Registration Number
- CTRI/2018/11/016407
- Lead Sponsor
- Encube Ethicals Private Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 13
1.Non Immunocompromised Male or non-pregnant, non-lactating female, 18 years and older at the time of signing the informed consent.
2.Subjects having confirmed diagnosis of atopic dermatitis for at least 3 months.
3.Subject with clinical diagnosis of moderate to severeatopic dermatitis that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or for whom those treatments are not advisable per Investigator.
4.Subject having an Investigatorâ??s Global Assessments (IGA) of disease severity of at least moderate [a score of 3 (moderate) or 4 (severe)] AND have a minimum SCORAD score of disease severity is >15.
5.Subject having an affected area of AD involvement of at least 20% Body Surface Area (BSA) at baseline, as defined by the Hanifin and Rajka criteria.
6.Subject 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.Both male and female subjects of child bearing potential must be practicing adequate contraception (for example total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the studyand female subjects 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.
8.Subject agrees to compliance with the protocol and adheres to the protocol requirements for the entire study period.
1.Subjects with diagnosis of atopic dermatitis for less than 3 months.
2.Reports active cutaneous bacterial or viral infection in any treatment area at baseline (e.g.,clinically infected atopic dermatitis).
3.Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations.
4.History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, orichthyosis
5.Females who are pregnant, lactating or likely to become pregnant during the study.
6.History or presence of Nethertonâ??s Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders.
7.Use within one month prior to baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB therapy, 3) PUVA (psoralen plus ultraviolet A) therapy, 4) tanning booths, 5) nonprescription UV light sources, 6) immunomodulators or immunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) Tacrolimus, or 10) Pimecrolimus.
8.Use within 14 days of baseline of: 1) systemic antibiotics, 2) Calcipotriene or other Vitamin D preparations, or 3) retinoids.
9.Use within 7 days prior to baseline of: 1) antihistamines, 2) topical antibiotics, 3) topical corticosteroids or 4) other topical drug products.
10. Use within 24 hours prior to baseline of any topical product (e.g., sunscreens, lotions, creams, emollient, moisturizers) in the areas to be treated.
11.Known allergy or hypersensitivity to Tacrolimus or any other component of the test product or RLD.
12.Not willing to minimize or avoid natural and artificial sunlight exposure during treatment.
13.Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
14.Demonstrates a positive test result for Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody.
15.Reports simultaneous participation in any other drug trial or participation in any other trial involving investigational medicinal product within 30 days of randomization. However, subjects can be enrolled considering elimination half-life of study drug of last participation and/or pharmacokinetic profile of such drug molecule of last participation and/or other medical judgment (if any) to justify the subjectâ??s participation based on investigator opinion and/or sponsor medical monitor.
16.Any other condition, that in the investigatorâ??s judgment, might compromise subject safety or affect study results
17.Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints and/or might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
18.Employees of the Investigator or research centre or their immediate family members
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint is the proportion of subjects in the Per <br/ ><br>Protocol (PP) population in each treatment group with treatment Success <br/ ><br>at Day 15 ± 2. Treatment Success is defined as an IGA score of 0 (clear) <br/ ><br>or 1 (almost clear) within all treatment areas based on the Investigatorâ??s <br/ ><br>Global Assessment of Disease at the end of treatment (week 2, visit 4; <br/ ><br>study Day 15).Timepoint: ï?· Visit 1: Screening(Day -14 to Day 0) <br/ ><br>ï?· Visit 2 Baseline (Day 0) <br/ ><br>ï?· Visit 3: Interim Visit (Day 4) <br/ ><br>ï?· Visit 4: End of Study/Early Termination (Day15 ± 2) <br/ ><br>ï?· Safety Follow up Visit: 7 days after the last application of study <br/ ><br>treatment. It can be performed telephonically.
- Secondary Outcome Measures
Name Time Method The secondary efficacy endpoints are: <br/ ><br>1. The proportion of subjects with Treatment Success at Day 15 ±2 <br/ ><br>2. The change in severity score from baseline to Day 15 ± 2 of the <br/ ><br>four individual signs and symptoms of AD (i.e., erythema, <br/ ><br>induration/papulation, lichenification, and pruritus). <br/ ><br>3. The proportion of participant who have achieved SCORAD <br/ ><br>score 15 in SCORAD scale of disease severity.Timepoint: Visit 1: Screening(Day -14 to Day 0) <br/ ><br>� Visit 2 Baseline (Day 0) <br/ ><br>� Visit 3: Interim Visit (Day 4) <br/ ><br>� Visit 4: End of Study/Early Termination (Day15 ± 2) <br/ ><br>� Safety Follow up Visit: 7 days after the last application of study <br/ ><br>treatment. It can be performed telephonically.