Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Scar Gel Product Family Clinical Investigation

29. juni 2026 opdateret af: Hanson Medical, Inc.

PMCF Investigation to Compare the Clinical Performance/Benefit of Dermatix With Dermatix Ultra

The purpose of this PMCF investigation is to determine whether there are differences between the two formulations (Dermatix and Dermatix Ultra) in improving keloid and hypertrophic scars clinical symptoms and in the overall scar perception (including scar appearance and treatment perception).

This PMCF investigation has been designed to address the conclusions of the latest CER [PDPROJ-4-CE-R] and the objectives. It has been chosen as an appropriate activity as it enables the collection of device-specific data on both device formulations and on the entire intended population. Moreover, the design of the PMCF investigation (single-center, parallel, open-label, two-arm, randomized controlled study) enables the direct comparison of the clinical performance/benefit between the two formulations.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

150

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The total number of subjects will be 75 per arm (150 total). However, to allow for potential dropouts and protocol deviations, the planned enrolment will be increased by approximately 10%, yielding a total of 84 per arm (168 total).

To ensure that both treatment groups include patients with (a) scars at risk of developing hypertrophic or keloid scars (i.e., recent scars) and (b) pre-existing hypertrophic or keloid scars (i.e., older scars), a stratified randomization procedure will be used. This approach will evenly distribute the proportion of older scars and recent scars between the two groups based on the estimated prevalence of pathological scars in the overall scar population.

Beskrivelse

Inclusion Criteria:

  • Patients aged >3 years.
  • Patients with keloids and hypertrophic scars (such as those resulting from general surgical procedures, trauma wounds, and burns), i.e., older scars.
  • Patients at risk of developing keloids and hypertrophic scars, i.e., recent scars.

Exclusion Criteria:

  • Patients with unhealed and/or open wounds.
  • Patients with allergies to any of the ingredients.
  • Pregnant or breastfeeding women.
  • Patients using other topical skin treatments on/around the scar area.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Recent Scar
Patients at risk of developing a hypertrophic or keloid scar, aged 3 years and older.
Enhed: Dermatix
Patients will be supplied with two 15g tubes of Dermatix at Visit 1 - Baseline Visit with the clinician, which will be sufficient to last the duration of the study (6-months) when applied as instructed (i.e. twice daily). If for any reason the patient runs out of the investigational product, a contingency supply will be in place and patients will be supplied with an additional tube. Patients will also be provided with the IFU of the supplied device and the clinician will provide instructions as to the application, frequency, and duration of use of the device (i.e. applied topically to the scar, twice daily for 6 months/until final study visit).
Enhed: Dermatix Ultra
Patients will be supplied with two 15g tubes of Dermatix Ultra at Visit 1 - Baseline Visit with the clinician, which will be sufficient to last the duration of the study (6-months) when applied as instructed (i.e. twice daily). If for any reason the patient runs out of the investigational product, a contingency supply will be in place and patients will be supplied with an additional tube. Patients will also be provided with the IFU of the supplied device and the clinician will provide instructions as to the application, frequency, and duration of use of the device (i.e. applied topically to the scar, twice daily for 6 months/until final study visit).
Older Scars
Patients with existing scars, aged 3 years and older,
Enhed: Dermatix
Patients will be supplied with two 15g tubes of Dermatix at Visit 1 - Baseline Visit with the clinician, which will be sufficient to last the duration of the study (6-months) when applied as instructed (i.e. twice daily). If for any reason the patient runs out of the investigational product, a contingency supply will be in place and patients will be supplied with an additional tube. Patients will also be provided with the IFU of the supplied device and the clinician will provide instructions as to the application, frequency, and duration of use of the device (i.e. applied topically to the scar, twice daily for 6 months/until final study visit).
Enhed: Dermatix Ultra
Patients will be supplied with two 15g tubes of Dermatix Ultra at Visit 1 - Baseline Visit with the clinician, which will be sufficient to last the duration of the study (6-months) when applied as instructed (i.e. twice daily). If for any reason the patient runs out of the investigational product, a contingency supply will be in place and patients will be supplied with an additional tube. Patients will also be provided with the IFU of the supplied device and the clinician will provide instructions as to the application, frequency, and duration of use of the device (i.e. applied topically to the scar, twice daily for 6 months/until final study visit).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Vancouver Scar Scale (VSS)
Tidsramme: 6 months of treatment

Comparison of clinical symptoms and scar appearance between Dermatix and Dermatix Ultra (between the two study arms) using the Vancouver Scar Scale (VSS), i.e.,

  • scar pigmentation
  • scar vascularity
  • scar pliability/elasticity
  • scar height
  • scar itchiness
  • scar pain
6 months of treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Satisfaction, Change from Baseline, Complications
Tidsramme: 6 months of treatment

  • Comparison of treatment satisfaction between Dermatix and Dermatix Ultra (between arms) after using a 5-point Likert scale to rate the treatment satisfaction as:

    1. unsatisfactory
    2. moderate
    3. good
    4. very good
    5. excellent

  • Change from baseline (within arms) of clinical symptoms and scar appearance using the VSS, i.e.,

    • scar pigmentation
    • scar vascularity
    • scar pliability/elasticity
    • scar height
    • scar itchiness
    • scar pain

  • The incidence of all complications during the study period, including:

    • Adverse Events (AE)
    • Serious Adverse Events (SAEs),
    • Serious Adverse Device Effects (SADE),
    • Unanticipated Serious Adverse Device Effect (USADE).
6 months of treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hanson Medical, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

29. juni 2026

Først indsendt, der opfyldte QC-kriterier

29. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PDPROJ-4-CI-P

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hypertrofiske ar

Kliniske forsøg med Dermatix

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in China

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner