Investigation on a Topical Cosmetic Pain Lotion (Egyfil) for Stiffness and Pain Relief

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-12

Study Completion Date

2021-07-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Muscle Rigidity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Egyfil Pain Lotion

Interventional study on Egyil 50mL will be topically administered ad libitum for three days.

Group Type EXPERIMENTAL

Egyfil Pain Lotion

Intervention Type 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.

Interventions

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Egyfil Pain Lotion

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. signed participants informed consent form (ICF);
2. male or Female, aged \> 18 years at the time of the signature of ICF;
3. 3 to 10 rating according to the Numerical Rating Scale (NRS), applied in participants with muscle tension pain;
4. willing to follow all study procedures;
5. willing to follow indications.

Exclusion Criteria

1. use of analgesics within the 24 hours prior to V1;
2. damaged skin in the area of treatment;
3. infective or prior inflammatory processes near the area of treatment;
4. ongoing cutaneous allergies;
5. serious and chronical pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy;
6. 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
7. immune system illnesses;
8. uncontrolled systemic diseases;
9. known drug and/or alcohol abuse;
10. mental incapacity that precludes adequate understanding or cooperation;
11. participation in another investigational study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No