Scar Gel Product Family Clinical Investigation
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Recent Scar
Patients at risk of developing a hypertrophic or keloid scar, aged 3 years and older.
|
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).
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,
|
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).
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).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Vancouver Scar Scale (VSS)
Zeitfenster: 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.,
|
6 months of treatment
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Satisfaction, Change from Baseline, Complications
Zeitfenster: 6 months of treatment
|
|
6 months of treatment
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PDPROJ-4-CI-P
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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