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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07257770

Enrollment

Registered

2025-12-02

Start date

2025-09-11

Completion date

2026-07-11

Last updated

2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mastalgia

Keywords

inositol, breast pain, mastalgia

Brief summary

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

DEVICEinositol

Topical application of a medical device based on inositol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Contacts

CONTACTMaria Ida Amabile

mariaida.amabile@uniroma1.it+393290847775

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026