Assessment of the "PAIN LOTION" Topical Preparation for the Relief of Stiffness, Reduced Mobility, and/or Mild to Moderate Musculoskeletal or Myofascial Pain: a Prospective Pre-market, Interventional, Single Arm Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Muscle Stiffness, measured by Numerical Rating Scale (NRS)
研究概览
简要总结
The application of a novel topical formulation for the treatment of muscular pain and stiffness (Egyfil), containing hyaluronic acid, SH-Polypeptide-6 and SH-Oligopeptide-1, is investigated to evaluate efficacy and safety in 26 patients with stiffness and pain. Single-Arm, Pre-Market, interventional study.
详细描述
26 male and female patients, ranging from 24 to 78 years old, will receive Egyfil Pain Lotion given for the treatment of pain and stiffness over a three-days period. The primary objective of the study is to evaluate the clinical performance of the lotion in providing relief from stiffness, reduced mobility, and muscle tension pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed participants informed consent form (ICF);
- •male or Female, aged > 18 years at the time of the signature of ICF;
- •3 to 10 rating according to the Numerical Rating Scale (NRS), applied in participants with muscle tension pain;
- •willing to follow all study procedures;
- •willing to follow indications.
排除标准
- •use of analgesics within the 24 hours prior to V1;
- •damaged skin in the area of treatment;
- •infective or prior inflammatory processes near the area of treatment;
- •ongoing cutaneous allergies;
- •serious and chronical pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy;
- •allergy to lotion components (aqua (water), glycerin, caprylic/capric triglyceride, aloe barbadensis leaf juice powder, simmondsia chinensis seed oil (simmondsia chinensis (jojoba) seed oil), phenoxyethanol, ammonium acryloyldimethyltaurate/vp copolymer, carbomer, tocopheryl acetate, tocopherol, benzoic acid, sodium hydroxide, sodium hyaluronate, dehydroacetic acid, ethylhexylglycerin, butyrospermum parkii butter (butyrospermum parkii (shea butter)), sorbitol, SH-polypeptide 6; SH-oligopeptide-1
- •immune system illnesses;
- •uncontrolled systemic diseases;
- •known drug and/or alcohol abuse;
- •mental incapacity that precludes adequate understanding or cooperation;
- •participation in another investigational study.
结局指标
主要结局
Muscle Stiffness, measured by Numerical Rating Scale (NRS)
时间窗: 3 days
The primary efficacy endpoint of the study will be the evaluation of the clinical performance of the Egyfil, used as intended in patients affected by muscle stiffness, in terms of difference in NRS score between the end study visit and baseline visit, assessed by patients Minimum index score: 0. Maximum index score: 10 0 means no stiffness
Pain, measured by Numerical Rating Scale (NRS)
时间窗: 3 days
The primary efficacy endpoint of the study will be the evaluation of the clinical performance of the Egyfil, used as intended in patients affected by Pain, in terms of difference in NRS score between the end study visit and baseline visit, assessed by patients Minimum index score: 0. Maximum index score: 10 0 means no pain
次要结局
- To evaluate the safety and tolerability of Pain Lotion when topically applied.(3 days)