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

February 12, 2026 updated by: Lo.Li.Pharma s.r.l

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Roma, Italy
        • Recruiting
        • Policlinico Umberto I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No treatment, clinical follow up
Experimental: treatment inositol
daily administration of the gel
Device: inositol
Topical application of a medical device based on inositol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of breast pain
Time Frame: 3 months
Breast pain is evaluated by using VAS (Visual Analogue Scale)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow up breast pain
Time Frame: 6 months
Breast pain is evaluated by using VAS (Visual Analogue Scale)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lo.Li.Pharma s.r.l

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2025

Primary Completion (Estimated)

April 11, 2026

Study Completion (Estimated)

July 11, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INO-BREAST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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