CTRI/2024/03/063709招募中Unknown
A Randomized, Double Blind, Placebo Controlled, Three arm, Parallel, Multicentre, Study to Evaluate the Bioequivalence using Clinical Endpoint of Pimecrolimus Cream, 1% of Encube Ethicals Private Limited, India to Pimecrolimus Cream, 1% of Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA in Treatment of Mild to Moderate Atopic Dermatitis. - Nil
试验速览
- 阶段
- Unknown
- 状态
- 招募中
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
- •1.Non-immuno compromised male or non-pregnant, non-lactating female aged 12 years and older with a clinical diagnosis of mild to moderate atopic dermatitis.
- •2.Subject with clinical diagnosis of mild to moderate atopic dermatitis that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or for whom those treatments are not advisable as per the Investigator.
- •3.Subject has confirmed diagnosis of atopic dermatitis for at least 3 months.
- •4.Subjects having an Investigator’s Global Assessment (IGA) of disease severity of mild or moderate at baseline. (a score of 2 (mild) or 3 (moderate)).
- •5.Subject having an affected area of atopic dermatitis involvement of at least 5 Percentage Body Surface Area (BSA) at baseline, as defined by the criteria of Hanifin and Rajka criteria.
- •6.Female subject must have a negative Urine Pregnancy Test at the time of screening or Female Subject of non-child bearing potential.
- •7.Female Subject of childbearing potential practicing an approved method of contraception that is stable at least 3 months prior to baseline and throughout the study. Acceptable forms of birth control include any of the following: (1) hormonal birth control, which must be stable for more than 3 months prior to baseline; (2) abstinence; subject must use condom plus spermicide if becomes sexually active; (3) double barrier method, such as condom plus spermicide.
- •8.Male Subject must use accepted methods of birth control or must agree to practice abstinence from study entry until the application of Investigational Product.
- •9.Willing to provide written informed consent or assent, as applicable. For Subjects who are considered minors (less than 18 completed years), the parent or legal guardian shall sign the consent form and the child shall be required to sign a Subject assent form, as appropriate.
排除标准
- •1.Females who are pregnant, breastfeeding, or who wish to become pregnant during the study period.
- •2.Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo).
- •3.Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations.
- •4.History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.
- •5.History or presence of Netherton’s Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders.
- •6.Concurrent disease or treatment likely to interfere with the study treatment or evaluations.
- •7.Use within one month prior to baseline of i) Oral or intravenous corticosteroids, ii) UVA/UVB therapy, iii) PUVA (psoralen plus ultraviolet A) therapy, iv) Tanning booths, v) Nonprescription UV light sources, vi) Immunomodulators or immunosuppressive therapies, vii) Interferon, viii) Cytotoxic drugs, ix) Tacrolimus and x) Pimecrolimus.
- •8.Use within 14 days of baseline of i) Systemic antibiotics, ii) Calcipotriene or other vitamin D preparations, iii) Retinoids.
- •9.Use within 7 days prior to baseline of i) Systemic antihistamines, ii) Topical antibiotics, iii) Topical corticosteroids, and iv) other topical drug products.
- •10.Use within 24 hours prior to baseline of any topical product (e.g., sunscreens, lotions, creams bland emollient/moisturizer) in the areas to be treated.
- •11.Known allergy or hypersensitivity to pimecrolimus or any other component of the test product or reference product
- •12.Not willing to minimize or avoid natural and artificial sunlight exposure during treatment
- •13.Subject with clinically significant vital sign abnormality.
- •14.Subject with clinically significant unstable medical disorders, life-threatening disease.
- •15.Subject who has been treated with an investigational drug or investigational device within a period of 30 days prior to study enrolment.
- •16.Subject who are directly employed at the study site and are associated with conduct of this study.
- •17.Living in the same household of a subject who is currently participating in this study or living in the same household of a subject who has previously participated in this study.
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