NCT06752460尚未招募不适用
Randomized, Open Clinical Study to Evaluate the Protective Potential of EF192B Versus No Treatment
Eurofarma Laboratorios S.A.1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年8月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Evaluate the effect of EF192B on the curative effect in the protection of small skin lesions through the formation of a barrier, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
研究概览
简要总结
This study was designed with the objective of evaluating the protection potential provided by the experimental product EF192B by evaluating its barrier formation capacity. Once its ability to form a barrier is confirmed, EF192B ability to protect against small skin injuries, such as small cuts, bruises, blisters and cracks is confirmed. The barrier formation also guarantees protection against the formation of calluses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70 years old.
- •Fitzpatrick skin phototype classification I to IV.
- •Presence of intact skin in the test region (right forearm and left forearm for selected participants).
- •Agreement to adhere to the study procedures and requirements and attend the institute on the days and times determined for the assessments.
- •Signing of the Informed Consent Form (ICF) and the Image Disclosure Consent Form (IDCF) before carrying out any study procedure.
排除标准
- •Diagnosis of skin diseases such as vitiligo, psoriasis, atopic dermatitis.
- •Diagnosis of immunological insufficiency.
- •Use of systemic corticosteroids or immunosuppressants.
- •Diagnosis of type 1 diabetes mellitus or insulin-dependent diabetes or presence of complications resulting from diabetes (such as retinopathy, nephropathy, neuropathy), presence of diabetes-related dermatoses (such as plantar ulcers, lipoid necrobiosis, granuloma annulare, opportunistic infections), history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma.
- •History of reaction to liquid dressings.
- •Known hypersensitivity to any ingredients of investigational product formulation.
- •Other diseases or use of drugs that may directly interfere with the study or put the research participant's health at risk.
- •Presence of any serious or uncontrolled diseases, at the investigator's discretion.
- •Pregnancy or lactation.
- •Participation in a clinical research protocol in the last 12 months, unless, at the investigator's discretion, their participation in the study may result in direct benefit to the participant.
- •Presence of any conditions that, at the investigator's discretion, make the participant unable to participate in the study.
研究组 & 干预措施
EF192B
Experimental
Application of the EF192B
干预措施: EF192B (Device)
Control area
No Intervention
结局指标
主要结局
Evaluate the effect of EF192B on the curative effect in the protection of small skin lesions through the formation of a barrier, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
时间窗: 12 hours
次要结局
- Efficacy of the EF192B in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.(12 hours)
- Evaluate the efficacy of EF192B barrier formation through the range of transepidermal water loss 3 minutes, 6 hours, and 24 hours after its administration(24 hours)
- Evaluate the efficacy of EF192B barrier formation through the range of corneometry 3 minutes, 6 hours, 12 hours, and 24 hours after its administration(24 hours)
- Evaluate EF192B water resistance after four washes(12 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Evaluation of the Protection of a Liquid BandageSkin CareNCT05888311Eurofarma Laboratorios S.A.72
已完成
2 期
Safety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A VaccineHepatitis ANCT01405677Crucell Holland BV308
已完成
2 期
Prospective Randomized Study Comparing Renal Artery Stenting (RESIST)With/Without Distal ProtectionRenal Artery StenosisNCT00234585University of Toledo Health Science Campus100
已完成
4 期
An Exploratory Study of the Safety and Efficacy of Prophylactic Immunomodulatory Treatment in Myozyme-naive Cross-Reacting Immunologic Material (CRIM[-]) Patients With Infantile-Onset Pompe DiseasePompe DiseaseGlycogen Storage Disease Type IINCT00701129Genzyme, a Sanofi Company4
已完成
4 期
Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEXProstate CancerNCT00590213AstraZeneca125