CTRI/2022/08/045019尚未招募3 期
A Randomized, Double-Blind, Vehicle-Controlled, Three arm, Parallel Group, Multi-Centric, Clinical Study to Establish the Therapeutic Equivalence of Tacrolimus 0.03% Topical Ointment of Intas Pharmaceuticals Limited with Protopic® 0.03% Topical Ointment in Patients with Moderate to Severe Atopic Dermatitis
Intas Pharmaceuticals Limited India0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •1 Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study.2 Man or woman participant must be aged 18 years or older, at the time of signing the informed
- •consent.3 Participants who are medically stable on the basis of physical examination, medical history,
- •and vital signs performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant source documents and initialed by the investigator.4 Participants who are medically stable on the basis of clinical laboratory tests performed at
- •screening. If the results of the serum biochemistry panel, hematology assessments are outside
- •the normal reference ranges, the participant may be included if the investigator judges the
- •abnormalities or deviations from normal to be not clinically significant or to be appropriate
- •and reasonable for the population under study.This determination must be recorded in the participant source documents and initialed by the investigator.5 A diagnosis of atopic dermatitis for at least 3 months (participant may verbally report signs and symptoms of atopic dermatitis with an onset at least 3 months prior to screening visit)6 Clinical diagnosis of moderate to severe atopic dermatitis (AD), as defined by the criteria of Hanifin and Rajka at screening visit• Affected area of AD involvement must be at least 10per cent body surface area (BSA) at baseline visit.7 A validated Investigator Global Assessment (vIGA) of disease severity of at least moderate at baseline visit (vIGA assessment score of 3 or 4).8 Participants must have failed to respond adequately to other topical prescription treatments
- •for atopic dermatitis, or for whom those treatments are not advisable in the opinion of investigator. (Participant verbal report of failure to other topical prescription treatments for AD can be considered.)9 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies-
- •Is not a woman of childbearing potential (WOCBP)
- •OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of more than 1 percent per year), with low user dependency when used consistently and correctly, during the intervention period and for at least 16 days,after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of 16 days after the last dose of study intervention. The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relationship to the first dose of study intervention.• A WOCBP must have a negative highly sensitive serum beta-human chorionic
- •gonadotropin (beta-hCG) test at screening and urine beta-hCG test at baseline.•If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.10 Male participants are eligible to participate if they agree to the
排除标准
- •1 Documented medical history of clinically significant cardiac, vascular, pulmonary,
- •gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or
- •metabolic disturbances or any other medical condition(s) for which, in the opinion of the
- •investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specifiedassessments.
- •2 Known allergies, hypersensitivity, or
- •intolerance to tacrolimus topical ointment or its
- •excipients (refer to the product monograph of Protopic®)
- •3 Contraindications to the use of tacrolimus 0.03% topical ointment per product monograph of
- •Protopic®.
- •4 Has documented medical history or current evidence of positive hepatitis B surface
- •antigen (HBsAg) at screening.
- •Has documented medical history or current evidence of positive hepatitis C antibody at
- •5 Has documented medical history or current evidence of human immunodeficiency virus
- •(HIV) infection at Screening.
- •6 Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is considered cured with minimal risk of recurrence.
- •7 Clinically significant severe renal insufficiency or severe hepatic disorders as judged by the investigator.
- •8 Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically
- •infected atopic dermatitis as judged by the investigator) requiring oral antimicrobials within
- •14 days prior to baseline and topical antimicrobials within 7 days prior to baseline.
- •9 Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline, which
- •would interfere with evaluations in the opinion of the investigator.
- •10 History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis
- •in the areas affected by atopic dermatitis or who are judged inappropriate for assessment of
- •AD in the present study as per investigatorâ??s discretion.
- •11 Participant with a known case of genetic epidermal barrier defect such as Nethertonâ??s
- •12 History or known case of congenital or acquired immunodeficiencies, which in the
- •investigatorâ??s opinion would contraindicate the use of immunosuppressants.
- •13 Presence of serious active infection (use of IV antimicrobials or invasive procedures required
- •for treatment), or recurrent infection as judged by the investigator, within last 14 days from
研究者
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