NCT05284487

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

Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel in the Prevention and Treatment of Radiation-induced Dermatitis in Patients With Head and Neck Cancer.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Welcare Industries SpA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary endpoint: * Mean time difference in development of G2 RID (according to CTCA) between Jalosome® and placebo arms. A median difference of at least 7 days is considered of clinical significance. • Secondary endpoints: * Proportion of subjects without G2 RID at the end of RT, in the Jalosome® and placebo arms. * Proportion of subjects without G2 RID at different timepoints (week 5, week 6 and two weeks after the last radiation) in the Jalosome® and placebo arms. * Worst skin toxicity during treatment and up to 2 weeks after the last radiation, according to CTCAE, in the Jalosome® and placebo arms. * RID grade (mean and worst) on the RISRAS scale, assessed weekly, in the Jalosome® and placebo arms. * Mean and worst score of PRO-Skindex-16 questionnaire performed weekly, in the Jalosome® and placebo arms. * Mean pain measured by the 11-point NRS of the Brief Pain Inventory (BPI), as reported in patients' diary (daily) and assessed during visits (weekly), in the Jalosome® and placebo arms. * Patient's compliance to Jalosome® treatment. * Patient's global satisfaction with Jalosome® treatment. * Jalosome® overall safety and tolerability. Study design: Monocentric, randomized, double-blind, placebo controlled clinical trial.

Conditions

• Radiation-induced Dermatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-27
• Primary completion: 2024-02-01
• Completion: 2024-03-01
• First posted: 2022-03-17
• Last updated: 2024-02-26

Locations

1 site across 1 country: Italy