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

Last updated: February 22, 2024
Sponsor: Welcare Industries SpA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy

Eczema (Atopic Dermatitis - Pediatric)

Scalp Disorders

Treatment

Jalosome® soothing gel

Placebo

Clinical Study ID

NCT05284487
JALOSOME-01
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 withoutconcurrent chemotherapy.
  • Willingness and ability to give informed consent and comply with study procedures.

Exclusion

Exclusion Criteria:

  • 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 mellitusor 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.

Study Design

Total Participants: 57
Treatment Group(s): 2
Primary Treatment: Jalosome® soothing gel
Phase:
Study Start date:
March 27, 2023
Estimated Completion Date:
March 31, 2024

Study 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.

Connect with a study center

  • IRCCS

    Milan, 20133
    Italy

    Active - Recruiting

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