PainNCT05711953
Investigation on a Topical Cosmetic Pain Lotion (Egyfil) for Stiffness and Pain Relief
A study testing Egyfil Pain Lotion in people with Pain and Muscle Rigidity, run by Contrad Swiss SA at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Muscle Rigidity
- What is being tested?
- Egyfil Pain Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jun 2021to 20 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pain, Muscle Rigidity
- Being tested
- Egyfil Pain Lotion
- Medical subject headings
- Pain, Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Egyfil Pain Lotion | Experimental | Interventional study on Egyil 50mL will be topically administered ad libitum for three days. Receives: Other: Egyfil Pain Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 days
Secondary outcomes (1)
To evaluate the safety and tolerability of Pain Lotion when topically applied.
To evaluate eventual side effects of the product Egyfil through the assessment made by the Principal Investigator.
Number of Participants with adverse events.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start12 Jun 2021
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contrad Swiss SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefano Picotti, Osteopathy, Principal investigator, Stefano Picotti - Individual Entrepeneur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711953
- Sponsor's protocol ID
- CTD-SW PAIN LOTION 2021
- Status last verified
- Jul 2023
- First submitted
- 25 Jan 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37784053
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05711953
- Acronym / sponsor ID
- CTD-SW PAIN LOTION 2021
- Conditions
- Pain, Muscle Rigidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Contrad Swiss SAIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2021 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Egyfil Pain Lotion | Experimental | Other: Egyfil Pain LotionInterventional study on Egyil 50mL will be topically administered ad libitum for three days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egyfil Pain LotionEgyfil 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. | Other | Egyfil Pain Lotion |
Primary outcome
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
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
1 secondary outcome
To evaluate the safety and tolerability of Pain Lotion when topically applied.
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 37784053Picotti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Picotti, Osteopathy principal investigator
Stefano Picotti - Individual Entrepeneur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egyfil Pain Lotion in people with Pain and Muscle Rigidity, run by Contrad Swiss SA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Stiffness, measured by Numerical Rating Scale (NRS) (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05711953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.