CTRI/2022/12/047916尚未招募未知
An Investigator Initiated, Randomized, Placebo and Active Controlled, Evaluator Blinded Study to Assess the Efficacy and Tolerability of Pimecrolimus Lotion 0.8% (ENZ001) in the Treatment of Target Lesions in Patients with Moderate Atopic Dermatitis.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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
- •Non-immunocompromised, Male and/or non-pregnant, or non-lactating female patient aged between 12 to 65 years (inclusive).
- •2. Patient with diagnosed Atopic Dermatitis (AD) for at least 6 months and currently in the active stage.
- •3. Patient with moderate Atopic Dermatitis (AD) on both sides
- •4. Patient with 2 symmetrical, comparable in severity and size, left/right treatment Target Lesions (TL) (on arms, legs, - torso). The target lesions must not be on the face, scalp, axilla, genitals, groin area, palms, back of the hands, and soles.
- •5. Patient with each Target Lesion with a TSS of at least 7 and Target Lesion should measure between 10 cm² and 100 cm².
- •6. Patient with both Target Lesions have similar severity (max 1 point difference in TSS), and of similar area
- •7. Patient who can sign Informed Consent Form (ICF) and is able to communicate with the investigator. Patient below 18 years of age (i.e. 12-17 years), the parent/guardian can sign ICF/assent form and can assist when necessary.
- •8. If female of childbearing potential, willing to use an acceptable form of birth control during the study.
- •9. Normally active and in good health by medical history and physical examination.
- •10. Patient who is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- •11. Patient residing within 15 Km of the designate study site.
排除标准
- •1.Female who is pregnant, breast feeding, or who plan to become pregnant during the study period.
- •2. Patient who has active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected AD).
- •3. Patient with non-AD lesion, skin disease, or infection on the Target Lesions that could interfere with the study assessments. 4. Patient who has Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations.
- •5. Patient with history of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
- •6. Patient with 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 28 days of baseline of: 1) systemic antibiotics, 2) systemic calcipotriene or other vitamin D preparations, 3) systemic retinoids, 4) systemic (oral/injectable) corticosteroids (Note: use of intranasal/inhaled or ophthalmic corticosteroids for stable medical conditions are allowed) or 5) systemic immunosuppressant (eg, dupilumab, methotrexate, ciclosporin, hydroxycarbamide (hydroxyurea), azathioprine, hydroxychloroquine, mycophenolate mofetil).
- •8. Use within 7 days prior to baseline of: 1) topical or antihistamines, 2) topical antibiotics, 3) topical corticosteroids/ immunomodulators or 4) other topical drug products such as antibacterial soaps (for bathing), or topical sodium hypochlorite-based products.
- •9. 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.
- •10. Known allergy or hypersensitivity to Pimecrolimus or any other component of the test product or reference product.
- •11. Patient unable to communicate efficiently with the Investigator or being unable to follow the study requirements.
- •12. Patient who is engaged in activities that involve excessive or prolonged exposure to sunlight or not willing to minimize or avoid natural and artificial sunlight exposure during treatment.
- •13. Other acute or chronic medical or psychiatric condition including recent (within the past year) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- •14. Patient with signs and symptoms suggestive of COVID 19 infection.
- •15. Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.
- •16. Institutionalized subject.
- •17. Living in the same household of a patient who is currently participating or living in the same household of a patient who has previously participated in the study.
研究者
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