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NCT Number: NCT07257770

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

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

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Key information

Conditions

Mastalgia Mastodynia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Umberto I

Roma, Italy

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inositol

Device

Topical application of a medical device based on inositol

Primary outcomes

  1. Reduction of breast pain

    Time frame: 3 months

    Breast pain is evaluated by using VAS (Visual Analogue Scale)

Secondary outcomes

  1. Follow up breast pain

    Time frame: 6 months

    Breast pain is evaluated by using VAS (Visual Analogue Scale)

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Ida Amabile

CONTACT

[email protected]

+393290847775

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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