Local Treatment of Breast Pain Based on the Daily Use of a Topical Gel
ConditionMastalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorLo.Li.Pharma s.r.l
About this trial
The trial aims to investigate the effect of a topical application of a medical device based on inositol in recovering breast pain
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Women under the age of 18
Ongoing systemic and/or local pain therapy
Pregnant women
Trial design
Design model
Parallel
Treatments tested in this trial
inositol
DeviceTopical application of a medical device based on inositol
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: treatment inositolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Reduction of breast pain
Breast pain is evaluated by using VAS (Visual Analogue Scale)
Time frame
3 monthsSecondary outcomes
1
Follow up breast pain
Breast pain is evaluated by using VAS (Visual Analogue Scale)
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov