Stefano Picotti
Cardano al Campo, Varese, 21010, Italy
NCT Number: NCT05711953
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cardano al Campo, Varese, 21010, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Egyfil is a cosmetic product to be applied to intact skin, useful to attenuate muscolar pain and stiffness, with a novel topical formulation containing hyaluronic acid, SH-Polypeptide-6 and SH-Oligopeptide-1.
The presence of sodium hyaluronate and peptides mixture promotes the pain alleviating activity and soothing properties of the product.
Time frame: 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
Time frame: 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
Time frame: 3 days
To evaluate eventual side effects of the product Egyfil through the assessment made by the Principal Investigator.
Number of Participants with adverse events.
Contrad Swiss SA
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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