Treatment for painful nipple lesions in breastfeeding women using low-level laser therapy
Low-Level-Lasertherapie (LLLT) Bei Schmerzhaften, Wunden Mamillen Stillender Frauen
This study is testing if low-level laser therapy can help breastfeeding women with painful nipple lesions feel better and heal faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zürich, Zurich) |
| Trial ID | NCT04259619 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of low-level laser therapy (LLLT) in treating painful nipple lesions in breastfeeding women. The study will enroll 194 participants who will be randomly assigned to receive either LLLT or placebo treatments over a period of 1 to 3 days. Participants will undergo assessments to classify their nipple lesions, evaluate potential causes, and analyze inflammatory parameters through blood samples. The goal is to determine if LLLT can reduce pain and promote healing, thereby supporting continued breastfeeding.
Who should consider this trial
Good fit: Ideal candidates are breastfeeding or expressing women aged 18 and older who are experiencing painful nipple lesions.
Not a fit: Patients with contraindications to the treatment, such as certain infections or skin conditions, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate pain for breastfeeding women, promoting longer breastfeeding duration and improving maternal-infant bonding.
How similar studies have performed: While low-level laser therapy has shown promise in other contexts, this specific application for nipple lesions in breastfeeding women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * signed written informed consent form * breast-feeding or pumping participant with painful nipple lesions * 18 years or older Exclusion Criteria: * contraindication for the class of medical device used or intervention being performed e.g. known hypersensitivity or allergy against the medical device or class of medical device * missing willingness to take part in the study * hepatitis B or C positive * human immunodeficiency virus (HIV) positive * intake of immunosuppressive drugs * epilepsy * dark or tattooed skin * lacking German or English skills * mamma carcinoma in past medical history * severe infection (C-reactive protein (CRP) \>200mg/l; leucocytes \>20000/ul)
Where this trial is running
Zürich, Zurich
- University Hospital Zurich — Zürich, Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Nicole Ochsenbein-Kölble, Prof.Dr.med. — leading physician
- Study coordinator: Nicole Ochsenbein-Kölble, Prof.Dr.med.
- Email: nicole.ochsenbein@usz.ch
- Phone: +41 79 921 52 28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.