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Recruiting NCT07257770

Local Treatment of Breast Pain Based on the Daily Use of a Topical Gel

No phase Interventional Mastalgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: inositol.
Who it may be relevant to
Registry conditions: Mastalgia. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluating the Effect of a Medical Device Based on Inositol in Improving Breast Pain

Overview

The trial aims to investigate the effect of a topical application of a medical device based on inositol in recovering breast pain

Detailed description

The present study enrolled patients with breast pain (measured through the VAS) aiming to evaluate the improvement of the pain after the local treatment

Interventions

  • Device inositol
    Topical application of a medical device based on inositol

Primary outcome measures

  • Reduction of breast pain [Time frame: 3 months]
Secondary outcome measures (1)
  • Follow up breast pain [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Women aged between 18 and 70 years
  • Women who underwent breast surgery at least 15 days prior
  • Women experiencing breast pain associated with the surgical wound

Exclusion criteria

  • Women under the age of 18
  • Ongoing systemic and/or local pain therapy
  • Pregnant women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Policlinico Umberto I — Roma

Identifiers

NCT: NCT07257770 · INO-BREAST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗