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

Lo.Li.Pharma

Status: Enrolling

Conditions: Mastalgia

Treatments: Device: inositol

Study type: Interventional

Funder types: Industry

Identifiers

NCT07257770

INO-BREAST

Details and patient eligibility

About

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

Full 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

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control

No Intervention group

Description:

No treatment, clinical follow up

treatment inositol

Experimental group

Description:

daily administration of the gel

Treatment:

Device: inositol