Local Treatment of Breast Pain Based on the Daily Use of... | NCT07257770

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

NCT07257770

Sponsor

Lo.Li.Pharma s.r.l

Status

Recruiting

Last Update Posted

Feb 13, 2026Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Mastalgia

Interventions

inositol

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2025Actual

Primary Completion Date

Apr 11, 2026Estimated

Completion Date

Jul 11, 2026Estimated

First Submitted Date

Nov 19, 2025

First Submission Date that Met QC Criteria

Nov 27, 2025

First Posted Date

Dec 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2026

Last Update Posted Date

Feb 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	No treatment, clinical follow up
treatment inositol	Experimental	daily administration of the gel	Device: inositol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inositol	Device	Topical application of a medical device based on inositol	treatment inositol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female - breast pain

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria Ida Amabile	Contact	+393290847775		mariaida.amabile@uniroma1.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Policlinico Umberto I	Recruiting	Roma			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059373	Mastodynia

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided