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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Egyfil Pain Lotion | Experimental | Interventional study on Egyil 50mL will be topically administered ad libitum for three days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Egyfil Pain Lotion | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Stiffness, measured by Numerical Rating Scale (NRS) | 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 | 3 days |
| Pain, measured by Numerical Rating Scale (NRS) | 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 | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of Pain Lotion when topically applied. | To evaluate eventual side effects of the product Egyfil through the assessment made by the Principal Investigator. Number of Participants with adverse events. | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Picotti, Osteopathy | Stefano Picotti - Individual Entrepeneur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stefano Picotti | Cardano al Campo | Varese | 21010 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37784053 | Derived | Picotti S, Forte L, Serrentino J. A pre-market interventional, single-arm clinical investigation of a new topical lotion based on hyaluronic acid and peptides, EGYFILTM, for the treatment of pain and stiffness in soft tissues. BMC Musculoskelet Disord. 2023 Oct 2;24(1):777. doi: 10.1186/s12891-023-06903-y. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009127 | Muscle Rigidity |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
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|
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009422 | Nervous System Diseases |