Clinical trial NCT05711953: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Muscle Rigidity
Lead sponsor: Contrad Swiss SA
Sponsor class: INDUSTRY
First posted: 2023-02-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Muscle Stiffness, measured by Numerical Rating Scale (NRS)
timeFrame: 3 days
measure: Pain, measured by Numerical Rating Scale (NRS)
timeFrame: 3 days
Secondary outcomes:
measure: To evaluate the safety and tolerability of Pain Lotion when topically applied.
timeFrame: 3 days
Other outcomes:
Locations:
city: Cardano Al Campo
country: Italy
facility: Stefano Picotti
state: Varese
Study officials:
affiliation: Stefano Picotti - Individual Entrepeneur
name: Stefano Picotti, Osteopathy
role: PRINCIPAL_INVESTIGATOR
References: