Nipple LesionsNCT04259619
Low-Level Laser Therapy (LLLT) Treatment for Breast-Feeding Women With Painful Nipple Lesions
A study testing Low-Level Laser Therapy in people with Nipple Lesions, run by University of Zurich at 1 site in Switzerland.
Trial summary
Around 30 to 90 percent of all breastfeeding women suffer from painful and sore nipple lesions. Reasons for these lesions are still not completely clarified. Nevertheless, irrespective of the underlying cause, these painful nipple lesions lead to an early stop of breastfeeding, which has negative consequences for the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nipple Lesions
- What is being tested?
- Low-Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Mar 2020to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed written informed consent form
- breast-feeding or pumping participant with painful nipple lesions
- 18 years or older
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Low-Level-Lasertherapie (LLLT) Bei Schmerzhaften, Wunden Mamillen Stillender Frauen
Around 30 to 90 percent of all breastfeeding women suffer from painful and sore nipple lesions. Reasons for these lesions are still not completely clarified. Nevertheless, irrespective of the underlying cause, these painful nipple lesions lead to an early stop of breastfeeding, which has negative consequences for the infant as well as for the mother. Even if the painful nipple lesions do not lead to a weaning of the baby, they cause an increased psychological distress for the mother and therefore may negatively influence the mother-child relationship.
Since breastfeeding is the natural and best possible type of nutrition for healthy, full term babies problems causing an early stop of breastfeeding should be addressed.
Read more
The low-level laser therapy (LLLT) represents a simple and low risk treatment to change (reduce) pain and accelerate wound healing. It is supposed to improve tissue organization and should have a positive anti-inflammatory and immune modulating effect. Therefore, this therapy is more and more frequently used to also treat painful nipple lesions, although hardly any studies have been conducted. Furthermore, in women with too little mother milk, the LLLT seems to increase the milk production.
The aim of this study is to investigate the positive effects of LLLT on painful and sore nipple lesions. This would justify a LLLT for women with painful nipple lesions on a wider scale, with the overall goal to reduce early stopping of breastfeeding and therefore having a positive impact on both, the child's health as well as the mother's wellbeing.
Read the detailed description
This study is conducted at the department of obstetrics of the University hospital of Zurich. 194 breastfeeding or expressing participants with sore and painful nipple lesions who fulfill the inclusion criteria are included in this study. If the participant meets any exclusion criteria she is excluded from this study. After being enrolled in the study, the participant is randomized to get either 3 low-level laser therapy (LLLT) treatments or 3 placebo treatments within 1 to 3 days.
Women having signed the declaration of consent and fulfill all inclusion criteria are then examined by a breastfeeding consultant. During this examination nipple lesions are classified into four different stages, causes for the lesions are evaluated and the nipple form is recorded. A swab of the milk is taken to rule out a pathogenetic colonization with germs. Then a blood sample is collected to analyze inflammatory parameters (C-reactive protein (CRP), leucocyte (Lc)), inflammation modulators (interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-α)) and the lactating hormone (prolactin). The taking of blood is repeated at the end of the third therapy. In the beginning and at the end of the last treatment, nipple lesions are classified and photographically documented. Specific instructions regarding the correct positioning and removal of the baby at the breast as well as breastfeeding positions are given to the women before starting the treatment. Women then breastfeed their baby once before and once after the entire therapy. Two hours after breastfeeding, the amount of milk is being measured after 15 minutes of pumping. Additionally, the sensation of pain is evaluated on the basis of a visual analog scale (VAS) from 1-10 and the satisfaction of the treatment is recorded before and after every single treatment. At the end of the last therapy, a final examination is conducted.
For the statistical analysis of the primary and secondary endpoints a proportional odds model is used.
- Conditions
- Nipple Lesions
- Being tested
- Low-Level Laser Therapy, Placebo Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser TherapyDevice
The low-level laser emits monochromatic, coherent, bundled laser light. In each therapy a energy dose of 2-4 Joul (J) / centimeter (cm)^2 is applied over a duration of about 30 seconds using level 1 (20 percent of maximum output) of the 350 milliwatt (mW) device.
Placebo TherapyDevice
The intervention is conducted identically to the low-level laser therapy but the placebo laser that is used emits only red light that is polychromatic, leading to a reduction in energy being emitted and therewith to no or a smaller effect.
| Study group | Role | What they receive |
|---|---|---|
| Low-Level Laser Therapy | Experimental | During 2-3 days this group receives three low-level laser therapy (LLLT) treatments with the Soft Power Laser carried out by a specially trained breastfeeding consultant. Receives: Device: Low-Level Laser Therapy |
| Placebo Therapy | Placebo comparator | During 2-3 days this group receives three placebo treatments with an identically looking laser, which in contrast submits only red colored light. The therapy is also carried out by a specially trained breastfeeding consultant. Receives: Device: Placebo Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction: visual pain scale from 1 (no pain) to 10 (worst pain)
The primary goal is to evaluate the pain change with the help of a visual pain scale form 1 to 10 (0 = no pain; 10 = worst pain).
Measured: though individual study completion, an average of 3 days
Secondary outcomes (3)
Wound Healing
One secondary goal is to evaluate the effect of the low-level laser therapy (LLLT) on wound healing. For this evaluation the nipple lesions are staged from 1-4 and photo documented and inflammatory markers (C reactive protein (CRP) and leucocytes (Lc)) and modulators (interleukin 6 (IL6) and tumor necrosis factor alpha (TNF-a) are analyzed in the blood.
Measured: though individual study completion, an average of 3 days
Milk Production
Another secondary goal is to evaluate the effect of the low-level laser therapy (LLLT) on milk production. This is done through measuring the milk production after 15 minutes pumping of both breasts and analyzing the prolactin in the blood.
Measured: though individual study completion, an average of 3 days
Satisfaction with the low-level laser therapy (LLLT): visual analogue scale from 1 (low satisfaction) to 10 (highest satisfaction)
An additional secondary goal is to evaluate the participants' degree of satisfaction with the LLLT. This is accomplished with the help of a visual analogue scaled.
Measured: though individual study completion, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start2 Mar 2020
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nipple LesionsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized double-blinded study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Ochsenbein-Kölble, Prof.Dr.med., Principal investigator, leading physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259619
- Sponsor's protocol ID
- 2019-01374
- Other IDs
- 2019
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2020
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Level-Lasertherapie (LLLT) Bei Schmerzhaften, Wunden Mamillen Stillender Frauen
- ClinicalTrials.gov ID
- NCT04259619
- Acronym / sponsor ID
- 2019-01374
- Conditions
- Nipple Lesions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Around 30 to 90 percent of all breastfeeding women suffer from painful and sore nipple lesions. Reasons for these lesions are still not completely clarified. Nevertheless, irrespective of the underlying cause, these painful nipple lesions lead to an early stop of breastfeeding, which has negative consequences for the infant as well as for the mother. Even if the painful nipple lesions do not lead to a weaning of the baby, they cause an increased psychological distress for the mother and therefore may negatively influence the mother-child relationship.
Since breastfeeding is the natural and best possible type of nutrition for healthy, full term babies problems causing an early stop of breastfeeding should be addressed.
The low-level laser therapy (LLLT) represents a simple and low risk treatment to change (reduce) pain and accelerate wound healing. It is supposed to improve tissue organization and should have a positive anti-inflammatory and immune modulating effect. Therefore, this therapy is more and more frequently used to also treat painful nipple lesions, although hardly any studies have been conducted. Furthermore, in women with too little mother milk, the LLLT seems to increase the milk production.
The aim of this study is to investigate the positive effects of LLLT on painful and sore nipple lesions. This would justify a LLLT for women with painful nipple lesions on a wider scale, with the overall goal to reduce early stopping of breastfeeding and therefore having a positive impact on both, the child's health as well as the mother's wellbeing.
Detailed description
This study is conducted at the department of obstetrics of the University hospital of Zurich. 194 breastfeeding or expressing participants with sore and painful nipple lesions who fulfill the inclusion criteria are included in this study. If the participant meets any exclusion criteria she is excluded from this study. After being enrolled in the study, the participant is randomized to get either 3 low-level laser therapy (LLLT) treatments or 3 placebo treatments within 1 to 3 days.
Women having signed the declaration of consent and fulfill all inclusion criteria are then examined by a breastfeeding consultant. During this examination nipple lesions are classified into four different stages, causes for the lesions are evaluated and the nipple form is recorded. A swab of the milk is taken to rule out a pathogenetic colonization with germs. Then a blood sample is collected to analyze inflammatory parameters (C-reactive protein (CRP), leucocyte (Lc)), inflammation modulators (interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-α)) and the lactating hormone (prolactin). The taking of blood is repeated at the end of the third therapy. In the beginning and at the end of the last treatment, nipple lesions are classified and photographically documented. Specific instructions regarding the correct positioning and removal of the baby at the breast as well as breastfeeding positions are given to the women before starting the treatment. Women then breastfeed their baby once before and once after the entire therapy. Two hours after breastfeeding, the amount of milk is being measured after 15 minutes of pumping. Additionally, the sensation of pain is evaluated on the basis of a visual analog scale (VAS) from 1-10 and the satisfaction of the treatment is recorded before and after every single treatment. At the end of the last therapy, a final examination is conducted.
For the statistical analysis of the primary and secondary endpoints a proportional odds model is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- prospective, randomized double-blinded study
| Arm | Type | Receives |
|---|---|---|
| Low-Level Laser Therapy | Experimental | Device: Low-Level Laser TherapyDuring 2-3 days this group receives three low-level laser therapy (LLLT) treatments with the Soft Power Laser carried out by a specially trained breastfeeding consultant. |
| Placebo Therapy | Placebo comparator | Device: Placebo TherapyDuring 2-3 days this group receives three placebo treatments with an identically looking laser, which in contrast submits only red colored light. The therapy is also carried out by a specially trained breastfeeding consultant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- signed written informed consent form
- breast-feeding or pumping participant with painful nipple lesions
- 18 years or older
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Level Laser TherapyThe low-level laser emits monochromatic, coherent, bundled laser light. In each therapy a energy dose of 2-4 Joul (J) / centimeter (cm)^2 is applied over a duration of about 30 seconds using level 1 (20 percent of maximum output) of the 350 milliwatt (mW) device. | Device | Low-Level Laser Therapy |
| Placebo TherapyThe intervention is conducted identically to the low-level laser therapy but the placebo laser that is used emits only red light that is polychromatic, leading to a reduction in energy being emitted and therewith to no or a smaller effect. | Device | Placebo Therapy |
Primary outcome
Pain Reduction: visual pain scale from 1 (no pain) to 10 (worst pain)
Time frame: though individual study completion, an average of 3 days
The primary goal is to evaluate the pain change with the help of a visual pain scale form 1 to 10 (0 = no pain; 10 = worst pain).
3 secondary outcomes
Wound Healing
Time frame: though individual study completion, an average of 3 days
Milk Production
Time frame: though individual study completion, an average of 3 days
Satisfaction with the low-level laser therapy (LLLT): visual analogue scale from 1 (low satisfaction) to 10 (highest satisfaction)
Time frame: though individual study completion, an average of 3 days
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
Related trials for Nipple Lesions
Active, not recruiting
A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts
Mammary Tumor, Nipple Discharge
Active, not recruitingObservational study
A Novel Fluorescent Ductal Needle for Localization and Sampling of High-risk Breast Micro Lesions
Mammary Tumor, Nipple Discharge
Recruiting
Evaluation of the Effectiveness and Safety of Laparoscopic Assisted Mastectomy With Preservation of Nipple and Areola, Immediate One-step Breast Reconstruction With Pectoral Muscle Prosthesis and Patch, and Simultaneous Autologous Fat Transplantation
Breast Cancer Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Ochsenbein-Kölble, Prof.Dr.med. principal investigator
leading physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy in people with Nipple Lesions, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Reduction: visual pain scale from 1 (no pain) to 10 (worst pain) (time frame: though individual study completion, an average of 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.