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Can cord blood platelets soothe a painful skin condition?

NCT ID NCT06661382

Disease control Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Source: ClinicalTrials.gov ↗

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether injections of platelet-rich plasma from cord blood can ease vulvar lichen sclerosus, a chronic skin condition causing itching, burning, and pain. Researchers will compare CB-PRP against a placebo in 100 women, giving three treatments four weeks apart. They will track satisfaction, symptoms, quality of life, and tissue changes over six months. The goal is to see if this regenerative approach offers relief when standard steroid creams fall short.

What this could mean

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

Active substance
Cord blood platelet-rich plasma (CB-PRP) injected into the vulvar area
What this could lead to
If it works, CB-PRP could offer a new option for women with vulvar lichen sclerosus who do not get enough relief from steroid creams, potentially easing symptoms and improving quality of life.
What could go wrong
This is an early-phase trial, so the treatment may not prove more effective than placebo. Risks include injection-related discomfort or reactions, and results may not apply to all patients.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

100 people

The number who actually took part.

Started

Jan 2023

Finished

Jun 2025

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 to 80 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * women with VLS (clinical/histological diagnosis) * good health conditions * written informed consent signed and dated by the patient Exclusion Criteria: * pregnancy * coagulopathies, platelet disorders, cardiovascular and/or respiratory diseases * ongoing major infections * previous vulvar surgery (e.g., lipostructure and/or previous PRP)

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Conditions

The condition(s) this trial relates to.

vulvar lichen sclerosus

As listed by the trial registrant

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

Vulvar lichen sclerosus

Contacts and locations

Locations

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    Milan, Milan, 20122, Italy

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