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Laser light may soothe sore nipples for breastfeeding moms

NCT ID NCT04259619

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether low-level laser therapy can reduce pain and help heal sore, cracked nipples in breastfeeding women. About 96 women with painful nipple lesions were randomly assigned to receive either real laser or a placebo light treatment. The goal was to see if the laser could ease pain and speed wound healing, potentially helping mothers breastfeed longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Low-Level Laser Therapy
What this could lead to
If it works, this could offer a simple, low-risk way to ease pain and speed healing for sore nipples, helping mothers breastfeed longer.
What could go wrong
The trial was terminated early with only 96 participants, so results are limited. The placebo device also emits red light, which may have some effect, making it hard to prove the laser's benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

96 people

The number who actually took part.

Started

Mar 2020

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University Hospital Zurich

    Zurich, Canton of Zurich, 8091, Switzerland