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

Contrad Swiss

Status: Completed

Conditions: Muscle Rigidity; Pain

Treatments: Other: Egyfil Pain Lotion

Study type: Interventional

Funder types: Industry

Identifiers

NCT05711953

CTD-SW PAIN LOTION 2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

26 participants in 1 patient group

Egyfil Pain Lotion

Experimental group

Description:

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

Treatment:

Other: Egyfil Pain Lotion