NCT05711953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

January 25, 2023

Last Update Submit

July 19, 2023

Conditions

PainMuscle Rigidity

Outcome Measures

Primary Outcomes (2)

  • Muscle Stiffness, measured by Numerical Rating Scale (NRS)

    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

    3 days

  • Pain, measured by Numerical Rating Scale (NRS)

    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

    3 days

Secondary Outcomes (1)

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

    3 days

Study Arms (1)

Egyfil Pain Lotion

EXPERIMENTAL

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

Other: Egyfil Pain Lotion

Interventions

Egyfil Pain LotionOTHER

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.

Egyfil Pain Lotion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed participants informed consent form (ICF);
  • male or Female, aged \> 18 years at the time of the signature of ICF;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stefano Picotti

Cardano al Campo, Varese, 21010, Italy

Location

Related Publications (1)

  • Picotti S, Forte L, Serrentino J. 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. BMC Musculoskelet Disord. 2023 Oct 2;24(1):777. doi: 10.1186/s12891-023-06903-y.

    PMID: 37784053DERIVED

MeSH Terms

Conditions

PainMuscle Rigidity

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNervous System Diseases

Study Officials

  • Stefano Picotti, Osteopathy

    Stefano Picotti - Individual Entrepeneur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 3, 2023

Study Start

June 12, 2021

Primary Completion

July 20, 2021

Study Completion

July 20, 2021

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

IT(1)