- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05711953
Investigation on a Topical Cosmetic Pain Lotion (Egyfil) for Stiffness and Pain Relief
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Varese
-
Cardano Al Campo, Varese, Italy, 21010
- Stefano Picotti
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Egyfil Pain Lotion
Interventional study on Egyil 50mL will be topically administered ad libitum for three days.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Stiffness, measured by Numerical Rating Scale (NRS)
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 |
3 days
|
Pain, measured by Numerical Rating Scale (NRS)
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 |
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the safety and tolerability of Pain Lotion when topically applied.
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. |
3 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stefano Picotti, Osteopathy, Stefano Picotti - Individual Entrepeneur
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTD-SW PAIN LOTION 2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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