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Comparative Clinical Trial on Neoviderm Skin Emulsion and Connettivi-na 0.2% Cream to Evaluate the Normalization Process of the Skin and Re-duction of Cutaneous Tension and Pain in Patients With Superficial Burns Grade 1 and 2

NCT05805917 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-04-20

No results posted yet for this study

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.

Conditions

  • Dermatology

Interventions

DEVICE

Neoviderm Skin Emulsion medical device

Neoviderm Skin Emulsion will be applied twice daily, to cover the entire cutaneous surface interested by burns, followed by a gentle massage to spread the product evenly of all the affected skin.

DRUG

Connettivina 0.2% Cream

Connettivina 0.2% Cream will be applied twice daily, to cover the entire cutaneous surface interested by burns, followed by a gentle massage to spread the product evenly of all the affected skin.

Sponsors & Collaborators

  • Istituto Ganassini S.p.A. di Ricerche Biochimiche

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2023-09-30
Completion
2023-12-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05805917 on ClinicalTrials.gov