CTRI/2024/02/062891招募中2 期
A phase II, multi centre, randomized, double blinded, placebo controlled, parallel group, two arm, clinical study to assess efficacy, safety and tolerability of norketotifen capsule 4 mg in the treatment patients with mild to moderate atopic dermatitis.
Bridge Pharma Inc0 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
- 2 期
- 状态
- 招募中
- 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
- •Key Inclusion;
- •1. Non immunocompromised male or female patients, 18 to 45 years of age, both inclusive, with a clinical diagnosis of mild to moderate atopic dermatitis based on Investigator Global Assessment IGA of disease severity.
- •2. Affected area of AD involvement at least 5 percent of BSA at baseline as defined by the criteria of Hanifin and Rajka.
- •3. Had a diagnosis of AD for at least 3 months.
- •4. Patients must have provided IEC approved written informed consent using
- •the latest version of the IEC informed consent form.
- •5. Patients must be in good health and free from any clinically significant disease apart from indication under study.
- •6. Patients able to comply with study procedures in the opinion of the investigator.
排除标准
- •1. Females who are pregnant, breast feeding, or who wish to become pregnant during the study period.
- •2. Newly diagnosed or treatment naive patients.
- •3. Patients with severe atopic dermatitis requiring systemic therapy for AD.
- •4. Any dermatological condition other than atopic dermatitis at baseline such as malignant and premalignant skin condition or scar or wound or pigmented lesion or sunburn at the application site or in its close vicinity that in the investigators opinion may interfere with the evaluation of the patient atopic dermatitis.
- •5. Active cutaneous bacterial, fungal or viral infection in any treatment area at baseline e.g., clinically infected atopic dermatitis.
- •6. Sunburn, extensive scarring, or pigmented lesions in any treatment area at baseline, which would interfere with evaluations.
- •7. History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
- •8. History or presence of Netherton Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders.
- •9. 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.
- •10. Use within 14 days of baseline of: 1) systemic antibiotics, 2) calcipotriene or
- •other vitamin D preparations, or 3) retinoids.
- •11. Use within 7 days prior to baseline of: 1) antihistamines, 2) topical antibiotics,
- •3) topical corticosteroids or 4) other topical drug products.
- •12. Use within 24 hours prior to baseline of any topical product (e.g., sunscreens,
- •lotions, creams) in the areas to be treated, except for bland emollient
- •(moisturizer).
- •13. Known allergy or hypersensitivity to norketotifen or any other component of
- •the test product or placebo.
- •14. Not willing to minimize or avoid natural and artificial sunlight exposure
- •during treatment.
- •15. Any form of substance abuse (including drug or alcohol abuse), psychiatric
- •disorder or condition which, in the opinion of the investigator, may invalidate
- •the communication with the investigator or adversely affect the study
- •16. Therapy with an investigational agent within the past 30 days from screening.
- •17. The receipt of an investigational medicinal product or participation in other
- •drug research study within a period of 30 days from screening.
- •18. Patients in whom oral administration of IMP is not possible.
- •19. Abnormal baseline findings considered by the investigator to indicate
- •conditions that might affect study endpoints.
- •20. Clinically significant laboratory test results or any other condition that, in the
- •investigator’s judgment, might increase the risk to the patient or decrease the
- •chance of obtaining satisfactory data needed to achieve the objectives of the
研究者
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