Back to resultsInvestigation on a Topical Cosmetic Pain Lotion (Egyfil) for Stiffness and Pain Relief
Primary Purpose
Pain, Muscle Rigidity
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Egyfil Pain Lotion
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
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.
Sites / Locations
- Stefano Picotti
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Egyfil Pain Lotion
Arm Description
Interventional study on Egyil 50mL will be topically administered ad libitum for three days.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05711953
Brief Title
Investigation on a Topical Cosmetic Pain Lotion (Egyfil) for Stiffness and Pain Relief
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 12, 2021 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
July 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Contrad Swiss SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Muscle Rigidity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Egyfil Pain Lotion
Arm Type
Experimental
Arm Description
Interventional study on Egyil 50mL will be topically administered ad libitum for three days.
Intervention Type
Other
Intervention Name(s)
Egyfil Pain Lotion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle Stiffness, measured by Numerical Rating Scale (NRS)
Description
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
Title
Pain, measured by Numerical Rating Scale (NRS)
Description
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
Secondary Outcome Measure Information:
Title
To evaluate the safety and tolerability of Pain Lotion when topically applied.
Description
To evaluate eventual side effects of the product Egyfil through the assessment made by the Principal Investigator.
Number of Participants with adverse events.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Picotti, Osteopathy
Organizational Affiliation
Stefano Picotti - Individual Entrepeneur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stefano Picotti
City
Cardano Al Campo
State/Province
Varese
ZIP/Postal Code
21010
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Investigation on a Topical Cosmetic Pain Lotion (Egyfil) for Stiffness and Pain Relief
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