CTRI/2025/01/079033尚未招募不适用
A Multicenter Global Clinical Study to Assess the Efficacy of a Topical Cream When Used by Children and Adults with Atopic Dermatitis
SGS Dallas Research Cente North Glenville Drive Suite Richardson TX1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical Grading (SCORAD) by the study dermatologist at baseline and weeks 1, 4 and 6
研究概览
简要总结
Atopic dermatitis (AD) is a chronic condition characterized by dryness, itchiness, and inflammation, often managed with topical corticosteroids (TCS). Prolonged TCS use poses risks, necessitating complementary approaches to enhance treatment outcomes and reduce reliance on TCS.
This double-blind, randomized, controlled cosmetic clinical trial aims to assess and compare the effects of the marketed moisturizing cream versus a comparator cream over 6 weeks. The study includes adults (18 to 55 years) and children (2 months to17 years) with at least one active mild-to-moderate AD lesion on the body (arms, legs, or torso). Participants apply a provided TCS for 7 to 14 days and as needed thereafter.
The study evaluates whether adjunctive use of moisturizers improves skin hydration, relieves dryness and itching, enhances AD management, and reduces long-term TCS usage, offering a safer, more effective approach to symptom relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Month(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Female or male, 2 months to 55 years of age, of local population at each testing site, with the following subgroups per cell: · Child subgroup: 2 months to 17 years (with approximately 50% of subjects ≤9 years of age per cell, and every effort will be made to enroll at least 1 subject age 1 year or younger per site and for enrolled subjects to be aged 2 months to 11 years of age) · Adult subgroup: 18 to 55 years
- •In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
- •Having Fitzpatrick skin type I-VI (refer to Appendix I: Fitzpatrick Skin Type).
- •Having at least 1 active atopic dermatitis (AD) lesion of mild to moderate severity on the arms, legs, or torso (not on the hands, feet, face, or neck) at baseline, as determined by the Dermatologist.
- •Willing to stop using on the body any medication or skin moisturizing treatment products (including sunscreen with moisturizer) for atopic dermatitis other than the provided test material, and willing to use the provided study materials instead as directed during the study.
- •Willing to have the skin assessed on the arms, legs, and torso.
- •Willing to not shave the test area (on the arms, legs, or torso) within 3 days of each study visit and willing to have body hair trimmed with scissors by clinic personnel during a clinic visit if needed for better visibility of the AD lesion.
- •Willing to have digital images taken of the dermatologist-selected lesion on the arms, legs, and torso.
- •Willing to provide written informed consent and able to read, speak, write, and understand any of the local languages in which the ICF is available (Hindi)
- •Willing to sign a photography release.
- •Willing to cooperate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, AE symptoms, or reactions immediately.
排除标准
- •Having been diagnosed with known allergies to skin care products or corticosteroids.
- •Females: Breastfeeding a child, pregnant, or planning to become pregnant during the study according to subject self-report.
- •Males: Having a pregnant partner or a partner who is planning to become pregnant.
- •Having a history of skin cancer within the past 5 years.
- •Using topical or systemic (not nasal or ocular) corticosteroids or systemic medications that will affect or have an indirect effect on eczema (including but not limited to betamethasone, clobetasol, desoximetasone, diflorasone, fluocinonide, fluticasone, halcinonide, halobetasol, mometasone, and triamcinolone) or have used the aforementioned medications within 2 weeks before study enrollment (those on a stabilized regimen of antihistamines for allergy will be allowed).
- •Having used topical hydrocortisone on the body within 7 days of enrollment.
- •Having used any prescription medication to treat eczema/atopic dermatitis within 2 weeks or over-the-counter (OTC) medication to treat eczema in the 3 days before study enrollment.
- •Having clinically active bacterial, fungal, or viral skin infections within 4 weeks of enrollment, according to subject self-report.
- •Having severe atopic dermatitis/eczema.
- •Having a health condition and/or pre-existing or dormant dermatologic disease on the test area (arms, legs, or torso) (eg, psoriasis, moderate to severe acne, acne conglobata, nodules, cysts, severe excoriations) that the Investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
- •Having observable sunburn, suntan, scars, nevi, excessive hair, tattoos, or other dermal conditions on the test areas (arms, legs, or torso) that might influence the test results in the opinion of the Investigator or designee.
- •Having a history of immunosuppression/immune deficiency disorders (including HIV infection, AIDS, multiple sclerosis, Crohn’s disease, rheumatoid arthritis), organ transplant (heart, kidney, etc), or currently using oral or systemic immunosuppressive medications and biologics (eg, azathioprine, belimumab, Cimzia, Cosentyx, cyclophosphamide, cyclosporine, Enbrel, Humira, Imuran, Kineret, mycophenolate mofetil, methotrexate, Orencia, prednisone, Remicade, Rituxan, Siliq, Simponi, Stelara, Taltz) and/or undergoing radiation or chemotherapy as determined by study documentation.
- •Having a disease such as asthma, diabetes, epilepsy, hypertension, hyperthyroidism, or hypothyroidism that is not controlled by diet or medication.
- •Having started a long-term medication within the last 2 months.
- •Having any planned surgeries or invasive medical procedures during the study.
- •Noninvasive medical procedures or surgeries will be reviewed for their impact on the study outcome and acceptability by the Investigator or designee.
- •Currently participating in any other clinical trial at the testing facility or another research facility or doctor’s office.
- •Having participated in any clinical trial involving the test area (arms, legs, or torso) within 2 weeks before study enrollment at the testing facility or another research facility or doctor’s office.
- •Â© SGS North America, Inc
- •Having started hormone replacement therapies (HRT) or hormones for birth control or menopause less than 3 months before study enrollment or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
- •Having started prescription testosterone therapy less than 3 months prior to study entry or planning on starting, stopping, or changing doses of testosterone therapy during the study (eg, testosterone cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or on a testosterone booster or prescription testosterone (eg, DHEA, Omnadren®, Sustanon®, testosterone cypionate, testosterone enanthate, testosterone propionate, testosterone phenylpropionate, tribulus).
结局指标
主要结局
Clinical Grading (SCORAD) by the study dermatologist at baseline and weeks 1, 4 and 6
时间窗: weeks 1, 4 and 6
次要结局
- Subject reporting of Subjective Irritation Parameters at baseline and weeks 1, 4 and 6
研究者
Dr Somesh Gupta
AIIMS Delhi
研究点 (1)
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