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Completed

NCT Number: NCT05711953

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stefano Picotti

Cardano al Campo, Varese, 21010, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Egyfil Pain Lotion

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.

Primary outcomes

  1. Muscle Stiffness, measured by Numerical Rating Scale (NRS)

    Time frame: 3 days

    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

  2. Pain, measured by Numerical Rating Scale (NRS)

    Time frame: 3 days

    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 outcomes

  1. To evaluate the safety and tolerability of Pain Lotion when topically applied.

    Time frame: 3 days

    To evaluate eventual side effects of the product Egyfil through the assessment made by the Principal Investigator.

    Number of Participants with adverse events.

Sponsors and collaborators

Lead sponsor

Contrad Swiss SA

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2023
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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