Comparative Clinical Trial on Neoviderm Skin Emulsion and Connettivina 0.2% Cream to Evaluate the Normalization Process of the Skin and Reduction of Cutaneous Tension and Pain in Patients With Superficial Burns Grade 1 and 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- To compare the change in skin tension by means of a corneometer, at baseline (V0) and after 14 days of treatment (V2). Change will be assessed
Study Overview
Brief Summary
It is a single centre, randomized (set up or distributed in a deliberately random way), open-label (study participants and researchers both know which treatment the patient is receiving), prospective, interventional, post-marketing, controlled (An experiment or clinical trial in which two groups are used for comparison purpose), non-inferiority study (a study that tests whether a new treatment is not worse than an active treatment it is being compared to).
The PRIMARY OBJECTIVE is to assess the reduction of skin tension in patients with 1st and 2nd degree superficial burns treated either with Neoviderm Skin Emulsion medical device or Connettivina 0.2% Cream.
Neoviderm Skin Emulsion soothes and relieves the skin, promoting its physiological normalization process. It is suitable for adults, children and infants in case of sunburns; 1st degree and 2nd degree superficial burns; superficial ulcers; protection before and after radiotherapy treatment; skin irritation and manifestations involving redness; skin cracks, including recurring ones; desquamative states; erythema; dry skin; small abrasions. It is also indicated only for adults in case of tattoo aftercare and chemical peel.
Detailed Description
Investigation Title:
Comparative clinical trial on Neoviderm Skin Emulsion and Connettivina 0.2% Cream to evaluate the normalization process of the skin and reduction of cutaneous tension and pain in patients with superficial burns grade 1 and 2.
Sponsor:
Istituto Ganassini S.p.A.di Ricerche Biochimiche
Medical Device:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patients should comply with all the following inclusion criteria.
- •Adult subjects, adolescents between 11 and 17 years, and children aged ≥ 3 years.
- •Both sexes (males and females).
- •Subjects or subjects'parents that have given the appropriate writ-ten informed consent (in accordance with local requirements) for the participation in the study at the time of enrolment,
- •Subjects with 1st and 2nd superficial burns, either of physical or liquid burns, with an affected cutaneous area ≤ 20% in adults, ≤ 15% in children between 10 and 15 years of age, and ≤ 10% in children between 3 and 10 years and seniors over 65 years of age.
Exclusion Criteria
- •Patients with any one of the following exclusion criteria are not eligible:
- •Subjects with chemically induced burns.
- •Subjects with electrically induced burns.
- •Hypersensitivity to the active ingredients of products under study, or to one or more excipients present in the products under study or known hypersensitivity to any other product containing the same active ingredients or excipients.
- •Subjects with concomitant infection of the affected burn or in-fected lesions and / or bleeding.
- •General disorders that can affect the safety or well-being of the subject or interfere with the response of the skin.
- •Current participation in another trial is not permitted unless it is a non-interventional study, and the sole purpose of the trial is for long-term follow up describing clinical features or survival data (registry).
- •Women who are known to be pregnant or breastfeeding.
Arms & Interventions
25 subjects treated with Neoviderm Skin Emulsion
Intervention: Neoviderm Skin Emulsion medical device (Device)
25 patients treated with Connettivina 0.2% Cream
Intervention: Connettivina 0.2% Cream (Drug)
Outcomes
Primary Outcomes
To compare the change in skin tension by means of a corneometer, at baseline (V0) and after 14 days of treatment (V2). Change will be assessed
Time Frame: At Screening (V0 Randomization and treatment will be assigned) and at V2 (day 14 after treatment). Change will be assessed
To compare the change in skin tension by means of a corneometer, at baseline (V0) and after 14 days of treatment (V2), in patients with 1st and 2nd degree superficial burns treated either with Neoviderm Skin Emulsion medical device or Connettivina 0.2% Cream. Change will be assessed
Secondary Outcomes
- To compare the change in pain by means of a Visual Analogue Scale (VAS), at baseline (V0) and after 14 days of treatment (V2). Changed will be assessed.(At Screening (V0 Randomization and treatment will be assigned) and at V2 (day 14 after treatment). Change will be assessed)
- To assess the health status of the skin. The measurement tool will be videodermatoscopy that will notice morphological qualities diagnosing skin changes at the baseline (V0) and after 14 days of treatment (V2). Changed will be assessed.(At Screening (V0 Randomization and treatment will be assigned) and at V2 (day 14 after treatment). Change will be assessed)