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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Vancouver Scar Scale (VSS)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Satisfaction, Change from Baseline, Complications
Prazo: 6 months of treatment
|
|
6 months of treatment
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PDPROJ-4-CI-P
Informações sobre medicamentos e dispositivos, documentos de estudo
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produto fabricado e exportado dos EUA
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