Vulvar Lichen SclerosusPhase 1/2NCT06661382
Use of Platelet Rich Plasma From Cord Blood vs Placebo in the Treatment of Vulvar Lichen Sclerosus
A Phase 1/2 study testing Infiltrative treatment with CB-PRP in people with Vulvar Lichen Sclerosus, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Vulvar lichen Sclerosus (VLS) is a cutaneous-mucosal dermatosis that causes in the adult female vulvar itching and burning due to scratching abrasions. Dyspareunia is often associated . The areas most affected are the labia minora, the periclitoral area, the navicular dimple, and the perianal area. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- Infiltrative treatment with CB-PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jan 2023to 24 Jun 2025
- Phase
- Phase 1/2
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women with VLS (clinical/histological diagnosis)
- good health conditions
- written informed consent signed and dated by the patient
Who cannot join
- pregnancy
- coagulopathies, platelet disorders, cardiovascular and/or respiratory diseases
- ongoing major infections
- previous vulvar surgery (e.g., lipostructure and/or previous PRP)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Milan, 20122
About this study
Vulvar lichen Sclerosus (VLS) is a cutaneous-mucosal dermatosis that causes in the adult female vulvar itching and burning due to scratching abrasions. Dyspareunia is often associated . The areas most affected are the labia minora, the periclitoral area, the navicular dimple, and the perianal area. The placement of VLS in the context of immune-mediated dermatoses is the basis of the rationale for treatment with high potency topical corticosteroids. However, in some cases, local corticosteroid therapy is not sufficient resulting in a significant impact on the quality of life of the patient. This gives rise to the need to identify new treatments such as regenerative medicine.
The term PRP (Platelet Rich Plasma) is used to describe a blood product generated by a two-step centrifugation process of whole blood of a patient to produce a concentration of platelets in a small volume of plasma. PRP can be produced from autologous, homologous blood or from cord blood (CB-PRP).
Our objective is to evaluate the efficacy of CB-PRP versus placebo in the treatment of VLS.
Read the detailed description
Lichen Sclerosus (LS) is a cutaneous-mucosal dermatosis characterized by chronic changes in the trophism and maturation of the epithelium and the connective tissue. In females, the vulvar region is affected in about 90% of cases, often constituting the only site involved. In the adult female, the predominant symptoms are vulvar itching and burning due to scratching abrasions. Dyspareunia is an often associated. The clinical course is irregular but progressive and is characterized by periods of relative quiescence alternating with episodes of exacerbation of symptoms. The areas most affected are the labia minora, the periclitoral area, the navicular dimple, and the perianal area. The placement of LS in the context of immune-mediated dermatoses is the basis of the rationale for treatment with high potency topical corticosteroids. However, in some cases, local corticosteroid therapy is not sufficient to achieve adequate compensation of the pathology, and significant changes may set in of the vulvar anatomy resulting in a significant impact on the quality of life of the patient. This gives rise to the need to identify new treatments such a regenerative medicine. The term PRP (Platelet Rich Plasma) is used to describe a blood product blood generated by a two-step centrifugation process of whole blood of a patient to produce a concentration of platelets in a small volume of plasma. In addition to platelets, PRP contains large amounts of chemical mediators that promote angiogenesis, recruitment and proliferation of cells implicated in tissue regeneration and healing. PRP can be produced from autologous, homologous (donor) blood or from cord blood (CB-PRP). The main difference between PRP from peripheral blood (PB-PRP) and that from cord blood concerns the relative amount of growth factors and pro- and anti-inflammatory molecules. CB-PRP has been shown to be advantageous from a therapeutic point of view compared with PB-PRP because it contains higher concentrations of anti-inflammatory molecules. In addition, the use of CB-PRP allows for a final product that is not conditioned by the patient's age and by any associated comorbidities, which may instead compromise the quality of PB-PRP. Finally, the advantages of CB-PRP are related to lower production costs and to the greater ease of product preparation. The preparation process of CB-PRP involves a collection of cord blood following the expulsion of the placenta. The blood is then centrifugated using a two-step process. The final product is then injected on the vulvar surface under vulvoscopic guidance. Treatment with PRP is free of any major side effects. The objective of the following study is to evaluate the efficacy of CB-PRP versus placebo in the treatment of VLS.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- Infiltrative treatment with CB-PRP
- Medical subject headings
- Vulvar Lichen Sclerosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infiltrative treatment with CB-PRPBiological
Injection of CB-PRP or placebo into the vulvar site. Three treatments are planned four weeks apart. Three and six months after the last treatment with CB-PRP/ placebo each participant will be re-evaluated by vulvoscopy and biopsy, and will be given validated questionnaires to assess satisfaction, symptoms, and quality of life, psychological state, and sexual function.
| Study group | Role | What they receive |
|---|---|---|
| Infiltrative treatment with CB-PRP Group | Experimental | Not described Receives: Biological: Infiltrative treatment with CB-PRP |
| Placebo infiltrative treatment Group | Placebo comparator | Not described Receives: Biological: Infiltrative treatment with CB-PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction in treatment group vs placebo group
We expect that women in the cord blood platelets rich plasma group will differ with regard of patient satisfaction through the compilation of the Likert scale: 1 very unsatisfied, 5 very satisfied.
Measured: 3 months
Secondary outcomes (6)
Patient Global Impression of Change in treatment group vs placebo group
We expect that women in the cord blood platelets rich plasma group will differ with regard of impression of global changes using the Patient Global Impression of Change Questionnaire.
Patient Global Impression of Change is a single item questionnaire measuring the global changes since the start of the study treatment on a 7-point scale (1 worst outcome, 7 better outcome).
Measured: 3 months
Change in symptomatology in treatment group vs placebo group
We expect that women in the cord blood platelets rich plasma group will differ with regard of symptoms (itching, burning, dyspareunia and dysuria) using specific likert scale: 0 no symptoms (better outcome), 10 worst symptoms (worst outcome).
Measured: 3 months
Mucosal trophism in treatment group vs placebo group
We expect that women in the cord blood platelets rich plasma group will differ with regard of objective change of mucosal trophism through vulvoscopy.
Measured: 3 months
Histological biopsy in treatment group vs placebo group
We expect that women in the cord blood platelets rich plasma group will differ with regard of changing of histological byopsy features, trough biopsy.
Measured: 3 months
Sexual activity changes in treatment group vs placebo group
We expect that women in the cord blood platelets rich plasma group will differ with regard of change in sexual life (considering sexual activity and sexual items like desire, orgasm, pain, lubrication and arousal) using Female Sexual Function Index.
Measured: 3 months
Quality of life changes in treatment group vs placebo group
We expect that women in the cord blood platelets rich plasma group will differ with regard quality of life, through Short Form Health Survey (12 items.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start24 Jan 2023
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar Lichen SclerosusStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Direzione Ginecologia, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- veronica Boero, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661382
- Sponsor's protocol ID
- FLIPP
- Status last verified
- Jul 2026
- First submitted
- 22 May 2023
- Last updated
- 2 Sep 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Platelet Rich Plasma From Cord Blood vs Placebo in the Treatment of Vulvar Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT06661382
- Acronym / sponsor ID
- FLIPP
- Conditions
- Vulvar Lichen Sclerosus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 28 Oct 2024 (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.
Vulvar lichen Sclerosus (VLS) is a cutaneous-mucosal dermatosis that causes in the adult female vulvar itching and burning due to scratching abrasions. Dyspareunia is often associated . The areas most affected are the labia minora, the periclitoral area, the navicular dimple, and the perianal area. The placement of VLS in the context of immune-mediated dermatoses is the basis of the rationale for treatment with high potency topical corticosteroids. However, in some cases, local corticosteroid therapy is not sufficient resulting in a significant impact on the quality of life of the patient. This gives rise to the need to identify new treatments such as regenerative medicine.
The term PRP (Platelet Rich Plasma) is used to describe a blood product generated by a two-step centrifugation process of whole blood of a patient to produce a concentration of platelets in a small volume of plasma. PRP can be produced from autologous, homologous blood or from cord blood (CB-PRP).
Our objective is to evaluate the efficacy of CB-PRP versus placebo in the treatment of VLS.
Detailed description
Lichen Sclerosus (LS) is a cutaneous-mucosal dermatosis characterized by chronic changes in the trophism and maturation of the epithelium and the connective tissue. In females, the vulvar region is affected in about 90% of cases, often constituting the only site involved. In the adult female, the predominant symptoms are vulvar itching and burning due to scratching abrasions. Dyspareunia is an often associated. The clinical course is irregular but progressive and is characterized by periods of relative quiescence alternating with episodes of exacerbation of symptoms. The areas most affected are the labia minora, the periclitoral area, the navicular dimple, and the perianal area. The placement of LS in the context of immune-mediated dermatoses is the basis of the rationale for treatment with high potency topical corticosteroids. However, in some cases, local corticosteroid therapy is not sufficient to achieve adequate compensation of the pathology, and significant changes may set in of the vulvar anatomy resulting in a significant impact on the quality of life of the patient. This gives rise to the need to identify new treatments such a regenerative medicine. The term PRP (Platelet Rich Plasma) is used to describe a blood product blood generated by a two-step centrifugation process of whole blood of a patient to produce a concentration of platelets in a small volume of plasma. In addition to platelets, PRP contains large amounts of chemical mediators that promote angiogenesis, recruitment and proliferation of cells implicated in tissue regeneration and healing. PRP can be produced from autologous, homologous (donor) blood or from cord blood (CB-PRP). The main difference between PRP from peripheral blood (PB-PRP) and that from cord blood concerns the relative amount of growth factors and pro- and anti-inflammatory molecules. CB-PRP has been shown to be advantageous from a therapeutic point of view compared with PB-PRP because it contains higher concentrations of anti-inflammatory molecules. In addition, the use of CB-PRP allows for a final product that is not conditioned by the patient's age and by any associated comorbidities, which may instead compromise the quality of PB-PRP. Finally, the advantages of CB-PRP are related to lower production costs and to the greater ease of product preparation. The preparation process of CB-PRP involves a collection of cord blood following the expulsion of the placenta. The blood is then centrifugated using a two-step process. The final product is then injected on the vulvar surface under vulvoscopic guidance. Treatment with PRP is free of any major side effects. The objective of the following study is to evaluate the efficacy of CB-PRP versus placebo in the treatment of VLS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infiltrative treatment with CB-PRP Group | Experimental | Biological: Infiltrative treatment with CB-PRP |
| Placebo infiltrative treatment Group | Placebo comparator | Biological: Infiltrative treatment with CB-PRP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women with VLS (clinical/histological diagnosis)
- good health conditions
- written informed consent signed and dated by the patient
Key exclusion criteria (4 listed)
- pregnancy
- coagulopathies, platelet disorders, cardiovascular and/or respiratory diseases
- ongoing major infections
- previous vulvar surgery (e.g., lipostructure and/or previous PRP)
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 |
|---|---|---|
| Infiltrative treatment with CB-PRPInjection of CB-PRP or placebo into the vulvar site. Three treatments are planned four weeks apart. Three and six months after the last treatment with CB-PRP/ placebo each participant will be re-evaluated by vulvoscopy and biopsy, and will be given validated questionnaires to assess satisfaction, symptoms, and quality of life, psychological state, and sexual function. | Biological | Infiltrative treatment with CB-PRP Group, Placebo infiltrative treatment Group |
Primary outcome
Patient satisfaction in treatment group vs placebo group
Time frame: 3 months
We expect that women in the cord blood platelets rich plasma group will differ with regard of patient satisfaction through the compilation of the Likert scale: 1 very unsatisfied, 5 very satisfied.
6 secondary outcomes
Patient Global Impression of Change in treatment group vs placebo group
Time frame: 3 months
Change in symptomatology in treatment group vs placebo group
Time frame: 3 months
Mucosal trophism in treatment group vs placebo group
Time frame: 3 months
Histological biopsy in treatment group vs placebo group
Time frame: 3 months
Sexual activity changes in treatment group vs placebo group
Time frame: 3 months
Quality of life changes in treatment group vs placebo group
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Related trials for Vulvar Lichen Sclerosus
Not yet recruitingPhase 2
Nemolizumab for LS
Lichen Sclerosus of Vulva
Not yet recruiting
Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Lichen Sclerosus Treated With Fat Grafting
Vulvar Lichen Sclerosus, Vulvar Atrophy
Recruiting
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Atrophic Vaginitis, Vaginal Atrophy
Recruiting
Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus
Vulvar Lichen Sclerosus
RecruitingPhase 2
Methotrexate for Severe Vulvar Lichen Sclerosus
Vulvar Lichen Sclerosus
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.
veronica Boero, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Infiltrative treatment with CB-PRP in people with Vulvar Lichen Sclerosus, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 2 Sep 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 Italy. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient satisfaction in treatment group vs placebo group (time frame: 3 months). 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 2 Sep 2026.