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Table 1 Inclusion and exclusion criteria

From: A pre-market interventional, single-arm clinical investigation of a new topical lotion based on hyaluronic acid and peptides, EGYFILTM, for the treatment of pain and stiffness in soft tissues

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 stiffness and/or pain due to muscle contracture, trauma, and/or overtraining;

Exclusion criteria:

1. use of analgesics within the 24 h prior to baseline visit (t0);

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 (Jojoba) seed oil, phenoxyethanol, ammonium acryloyldimethyltaurate/vp copolymer, carbomer, tocopheryl acetate, tocopherol, benzoic acid, sodium hydroxide, sodium hyaluronate, dehydroacetic acid, ethylhexylglycerin, 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.