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Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel.

NCT05284487 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-02-26

No results posted yet for this study

Summary

Primary objective

\- To investigate the effectiveness of Jalosome® compared with placebo in the prevention and treatment of RID in patients with HNC undergoing RT.

Secondary objectives:

* To investigate the effectiveness of Jalosome® in reducing the maximum severity of RID compared with placebo.
* To investigate the effect of Jalosome®, compared with placebo, on patients' quality of life.
* To investigate safety and tolerability of Jalosome®.
* To investigate patient's compliance to Jalosome® treatment.
* To investigate patient's global satisfaction with Jalosome® treatment.

Conditions

  • Radiation-induced Dermatitis

Interventions

DEVICE

Jalosome® soothing gel

Jalosome® Soothing gel is a phospholipid based vesicular system based on hyaluronic acid (HA). HA supports the process of formation of extracellular matrix and collagen synthesis by fibroblasts, favoring the formation of a well-vascularized granulation tissue and thus accelerating the healing process. Jalosome® Soothing gel contains other active ingredients: Acetyl-L-carnitine which plays an important role as shuttle for energy production and is involved in cellular metabolism. It is an effective cytoprotective, anti-inflammatory, neuroprotective, metal chelator, anti-apoptotic and anti-oxidant agent. Allantoin is a key constituent of comfrey (Symphytum officinale L), it has moisturizing and keratolytic effect, increasing the water content of the extracellular matrix and enhancing desquamation of upper layers of dead skin cells. Hydrogenated phosphatidylcholine is a permeation enhancers, which increases the solubilization of active ingredients, improving their skin permeation ability.

DEVICE

Placebo

The placebo does not contain the active ingredients of Jalosome, only the co-formulants.

Sponsors & Collaborators

  • Welcare Industries SpA

    lead INDUSTRY

Principal Investigators

  • Nicola Alessandro Iacovelli · Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-27
Primary Completion
2024-02-29
Completion
2024-03-31

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 NCT05284487 on ClinicalTrials.gov