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

NCT05284487 | Unknown

• 1 other identifier: JALOSOME-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time to development of G2 RID

  Mean number of days in development of G2 RID (according to CTCA), in the Jalosome® and placebo arms.

  9 weeks

Secondary Outcomes (8)

• Subjects without G2 RID at the end of RT

  9 weeks

• Subjects without G2 RID at different timepoints

  9 weeks

• Worst skin toxicity

  9 weeks

• RID grade on the RISRAS

  9 weeks

• PRO-Skindex-16 questionnaire score

  9 weeks

Study Arms (2)

Group 1: Jalosome® Soothing gel

ACTIVE COMPARATOR

Jalosome® soothing gel ((L-Acetyl Carnitine chloridrate, Allantoin, Hydrogenated phosphatidylcholine, Sodium Hyaluronate) will be applied to the irradiated area two times daily (morning after RT and evening). The first application will start in the morning after the first RT session and will continue up to two weeks after completion of RT. Visit 1: Screening (days -7 to 0) Visit 2: Randomization and start of RT (day 1) Visit 3 -Visit 9/10: RT treatment Last visit: 2 weeks after last RT

Device: Jalosome® soothing gel

Group 2: Placebo

PLACEBO COMPARATOR

Placebo will be applied to the irradiated area two times daily (morning after RT and evening). The first application will start in the morning after the first RT session and will continue up to two weeks after completion of RT. Visit 1: Screening (days -7 to 0) Visit 2: Randomization and start of RT (day 1) Visit 3 -Visit 9/10: RT treatment Last visit: 2 weeks after last RT

Device: Placebo

Interventions

Jalosome® soothing gel DEVICE

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.

Group 1: Jalosome® Soothing gel

Placebo DEVICE

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

Group 2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subject aged ≥18 years old.
• Performance status 0-1.
• Diagnosis of HNC (epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinuses or salivary glands).
• Postoperative or curative RT (total radiation dose of at least 60 Gy), with or without concurrent chemotherapy.
• Willingness and ability to give informed consent and comply with study procedures.

You may not qualify if:

• Pregnant or lactating women.
• Previous RT on the head and neck area.
• Planned to receive concurrent cetuximab.
• Cutaneous and/or connective diseases (i.e. lupus erythematosus or scleroderma).
• Systemic diseases known to delay the skin healing process, such as diabetes mellitus or severe renal failure.
• Use of a tissue-equivalent bolus.
• Use of over-the-counter topical medications containing steroids.
• Presence of rashes or unhealed wounds in the radiation field.
• Recent sun exposure (\<1 month).
• Mental conditions that could adversely affect subject's adherence to the study.

Sponsors & Collaborators

• Welcare Industries SpA: lead

Study Sites (1)

IRCCS

Milan, 20133, Italy

RECRUITING

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Nicola Alessandro Iacovelli

  Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Gobbino

CONTACT

+39 (0)763 316353; r&s@welcaremedical.com

Fulvia Lazzarotto, CEO

CONTACT

+39 (0)763 316353; fl@welcaremedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 17, 2022
• Study Start: March 27, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 26, 2024

Record last verified: 2023-03

Locations

IT (1)