To understand the safety and outcome of Tacrolimus ointment 0.1% in patients suffering from Atopic dermatitis

Phase 3

Completed

• Conditions: Atopic dermatitis, unspecified,

• Registration Number: CTRI/2023/05/052282
• Lead Sponsor: JAMP Pharma Corporation

Brief Summary

This study is a Double-Blind, Randomized, Placebo-Controlled, Three-Arm, Parallel-Group, Multi-Centre Clinical Study to evaluate the Safety and Clinical Endpoint Bioequivalence of Tacrolimus Ointment 0.1% w/w of JAMP Pharma Corporation, Canada and PrProtopic® tacrolimus ointment, 0.1% (w/w) of LEO Pharma Inc., Thornhill, Ontario, L3T 7W8 and Compare Both Active Treatments to a Placebo Control in the Treatment of Non-immunocompromised Patients with Moderate to Severe Atopic Dermatitis. for this study No. of subjects is 450,180 subjects for Test, 180 subjects for Reference and  90 subjects for Placebo, Where the primary endpoint is the proportion of patients in the Per Protocol (PP) population in each treatment group with treatment success (i.e., a grade of clear or almost clear, a score of 0 or 1, within all treatment areas) based on the Investigator’s Global Assessment of Disease Severity at the end of treatment (Week 2 visit: Study Day 15) and the secondary endpoints are change in severity from baseline to Week 2 (Study Day 15) of four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus) and are considered supportive information.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-07
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Non-immunocompromised male or female patients, greater than or equal to 12 years of age.
• Has a definite clinical diagnosis of moderate to severe atopic dermatitis for at least 3 months with greater than or equal to 20% BSA being affected at baseline as defined by the criteria of Hanifin and Rajka.
• Has, according to the Hanifin and Rajka Criteria, at least three of the following,itching, chronic relapsing course, typical morphology and distribution of lesions (ie, flexural lichenification and linearity in adults; facial and extensor involvement during infancy and childhood), or familial and/or personal history of other atopic disorders (ie, asthma, allergic rhino-conjunctivitis, atopic dermatitis) 4.
• Has a Baseline Investigators Global Assessment score of at least moderate greater than or equal to 3.
• Has moderate to severe atopic dermatitis for which the use of alternative, conventional therapies are deemed inadvisable because of potential risks, or are not adequately responsive or are intolerant to other topical prescription treatments for AD or alternative, conventional therapies.
• In case of female patients with childbearing potential (a female who is not postmenopausal for greater than 2 years and has not undergone a tubal ligation or a hysterectomy), the patient should have a negative urine pregnancy test at screening and should be willing to use an acceptable form of birth control during the study.
• Patients willing to provide a study specific Institutional Review Board (IRB) approved written informed consent for this study.
• Patients willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and complete the study.
• Patients who agree to adhere to protocol-specified requirements and concomitant therapy restrictions during the study, including discontinuation of non-medicated topical agents such as creams, lotions, and emollients (to treatment area); topical antihistamines; topical antimicrobials; topical antifungals; topical or systemic corticosteroids; light treatments (ultraviolet A [UVA], UVB); non-steroid immunosuppressants; and other investigational drugs.
• Patients who are otherwise in good health, as confirmed by medical history and physical examination, and free from any clinically significant disease, other than atopic dermatitis, that might interfere with the study evaluations.
• Has a physical condition which enable patients to be fit for a Pharmacokinetic sampling, according to principal investigator evaluation.

Exclusion Criteria

• Female patients who are pregnant, nursing, or planning a pregnancy within the study participation period.
• Has clinically infected atopic dermatitis at Baseline i.e., Active cutaneous bacterial or viral infection in any treatment area at the baseline.
• Has a skin disorder other than atopic dermatitis or history or presence of skin disorders that may interfere with the study evaluations (ie, Netherton’s Syndrome, psoriasis, rosacea, topical fungal infections, erythroderma or ichthyosis, etc.).
• Has sunburn, pigmentation, extensive scarring, or pigmented lesions in the proposed treatment areas at the baseline, which could interfere with the rating of efficacy parameters.
• Has known or suspected history or presence of a clinically significant systemic disease (ie, immunological deficiencies, human immunodeficiency virus [HIV]), unstable or not controlled medical disorders (ie, unstable diabetes, unstable hypertension), life threatening disease, or current malignancies, serious active or recurrent infection or clinically significant severe renal insufficiency or severe hepatic disorders or any other significant medical condition likely to compromise participation in the study or the outcome of assessments, or to place the patient at risk.
• Has been treated with photo anti-psoriatic therapies/drugs, UVA/UVB therapy, psoralen plus ultraviolet A (PUVA) therapy, tanning booths, non-prescription UV light sources, immunomodulators or immunosuppressive therapies, interferon, cytotoxic drugs, tacrolimus, or pimecrolimus within 1 month prior to study entry.
• Has taken systemic corticosteroids (ie, oral or intravenous or intramuscular) within the past 1 month.
• Has been treated with any marketed or investigational biologic treatment for psoriasis or atopic disease (eg, alefacept, efalizumab, infliximab, adalimumab, etanercept, etc.) within the past three months or five half-lives of the biologic, whichever is longer.
• Vaccinations will not be considered as an exclusionary biologic treatment.
• Has been treated within 14 days of baseline with any of: systemic antibiotics, calcipotriene or other vitamin D preparations, or retinoids.
• Has applied topical antimicrobials, topical or oral antihistamines, topical corticosteroids, topical antifungals or other medicated topical agents to the affected areas within the past seven days.
• Has applied any topical agents (including creams, ointments, gels, lotions, and emollients) in the areas to be treated within the previous 24 hours.
• Patients who are currently using calcium channel blockers (e.g, amlodipine, nifedipine, verapamil, diltiazem, felodipine, isradipine, nisoldipine, etc) and/or cimetidine which are CPY3A inhibitors.
• Has a known hypersensitivity to any of the following (in any dosage form): tacrolimus, macrolides (i.e., erythromycin), or any excipient of the ointment.
• Patients who are not willing to avoid constant sun exposure and the use of tanning booths or other UV light sources during their participation in the study.
• Patients who tend consume excessive amounts of alcohol, abuse drugs, or has any condition that would compromise compliance, in the investigator’s opinion, with the protocol.
• Has been treated with an investigational drug or investigational device within a period of 30 days prior to study entry.
• Any history of difficulty in accessing veins to draw blood.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the proportion of patients in the Per Protocol (PP) population in each treatment group with treatment success (i.e., a grade of clear or almost clear, a score of 0 or 1, within all treatment areas) based on the Investigator’s Global Assessment of Disease Severity at the end of treatment.	From baseline to Day 4, Day 7 & Day 15

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints are change in severity from baseline to Week 2 (Study	Day 15) of four individual signs and symptoms of AD (i.e., erythema,

Trial Locations

Locations (15)

Government Medical College & Government General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

KIMS Hospital and Research Center; 🇮🇳 Bangalore, KARNATAKA, India

KKasturi Medicare Pvt. Ltd.,; 🇮🇳 Thane, MAHARASHTRA, India

KR Hospital; 🇮🇳 Mysore, KARNATAKA, India

KRM Hospital and Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Lifeline Diagnostic Center cum Nursing Home; 🇮🇳 Kolkata, WEST BENGAL, India

Lifepoint Multispecialty Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Medipoint Hospitals Pvt Ltd; 🇮🇳 Pune, MAHARASHTRA, India

Oyster and Pearl Hospitals (Phadnis Clinic Pvt Ltd); 🇮🇳 Pune, MAHARASHTRA, India

Rajalakshmi Hospital; 🇮🇳 Bangalore, KARNATAKA, India

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Government Medical College & Government General Hospital (Old RIMSGGH)

🇮🇳Srikakulam, ANDHRA PRADESH, India

Dr Revathi V

Principal investigator

9908066043

drrevathivggh@gmail.com