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Can a daily drink ease vaginal dryness in lichen sclerosus?

NCT ID NCT07450625

Symptom relief Sponsor: San Gallicano Dermatological Institute IRCCS 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 tests whether an oral collagen supplement (Collagendep) can reduce vulvar dryness in 40 women with genital lichen sclerosus who are also receiving fat grafting. Participants take the supplement daily for 4 months. The main goal is to see if dryness improves, with secondary checks on skin hydration and sexual function.

What this could mean

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

Active substance
Collagendep Pink Beauty (collagen peptides, hyaluronic acid, nucleotides, herbal extracts)
What this could lead to
If it works, this could provide a simple, non-hormonal way to improve vaginal moisture and comfort in women with lichen sclerosus who already receive fat grafting.
What could go wrong
This is a small, early-stage trial with only 40 participants. The supplement may not provide additional benefit over fat grafting alone, 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

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

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: * Female patients aged 18 years or older. * Clinical diagnosis of Genital Lichen Sclerosus. * Patients with a clinical indication for autologous fat grafting (lipofilling) treatment. * Ability to provide written informed consent. * Willingness to comply with the study protocol and attend all scheduled follow-up visits. Exclusion Criteria: * Presence of active local or systemic infections. * Current pregnancy or breastfeeding. * Known hypersensitivity or allergy to any of the ingredients of the study product "Collagendep Pink Beauty" (e.g., collagen, hyaluronic acid, herbal extracts). * Concurrent use of other oral supplements that might interfere with the evaluation of the study results. * Patients with oncological pathologies (malignancies) in the vulvar area. * Inability to guarantee adequate follow-up or compliance with the treatment regimen.

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Conditions

The condition(s) this trial relates to.

lichen sclerosus et atrophicus vulvar lichen sclerosus

As listed by the trial registrant

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

Vulvar atrophy Vulvar lichen sclerosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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