Vulvar Lichen SclerosusVULIS-3TNCT07240389
Treatment of Vulvar Lichen Sclerosus With Corticosteroid Ointment, Calcineurin Inhibitor Ointment, and Platelet-Rich Plasma (PRP) Therapy.
A study testing Platelet-Rich Plasma (PRP) Treatment, Clobetasol Propionate 0.05% Cream (Dermovate) and Pimecrolimus Cream (Elidel) in people with Vulvar Lichen Sclerosus, run by Milosz Pietrus at 1 site in Poland.
Trial summary
Vulvar lichen sclerosus (VLS) is a chronic inflammatory skin condition that affects the vulvar area, often causing itching, burning, and pain, and may lead to scarring and narrowing of the vaginal opening. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- Platelet-Rich Plasma (PRP) Treatment, Clobetasol Propionate 0.05% Cream (Dermovate) and Pimecrolimus Cream (Elidel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30 to 80 years.
- Clinical diagnosis of vulvar lichen sclerosus confirmed by histopathological examination.
- Ability and willingness to provide written informed consent for participation in the study.
- Ability to comply with study procedures, including questionnaire completion and follow-up visits at baseline, 3 months, and 6 months.
Who cannot join
- Lack of written informed consent to participate in the study.
- Prior treatment for vulvar lichen sclerosus (any systemic or topical therapy targeted at VLS).
- Current or past vulvar neoplasia, including vulvar intraepithelial neoplasia (VIN) or vulvar carcinoma.
- Other organic or dermatologic causes of vulvar symptoms that could interfere with diagnosis or outcome evaluation.
- Any condition that, in the opinion of the investigator, would interfere with study participation, follow-up, or accurate interpretation of results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Klinika Ginekologii i Ginekologii Onkologicznej, Szpital Uniwersytecki w Krakowie
Krakow, Małopolska, 31-261
About this study
Official title: Evaluation of Therapeutic Outcomes in Vulvar Lichen Sclerosus Treated With Corticosteroids, Calcineurin Inhibitors, and Platelet-rich Plasma (PRP).
Vulvar lichen sclerosus (VLS) is a chronic inflammatory skin condition that affects the vulvar area, often causing itching, burning, and pain, and may lead to scarring and narrowing of the vaginal opening. The condition significantly reduces the quality of life and may increase the risk of cancerous changes if left untreated.
This clinical study aims to evaluate and compare three commonly used treatment methods for women with biopsy-confirmed vulvar lichen sclerosus:
Read more
Topical corticosteroid therapy (clobetasol propionate 0.05%),
Topical calcineurin inhibitor therapy (pimecrolimus), and
Platelet-rich plasma (PRP) injections, which use the patient's own blood plasma rich in growth factors to support tissue healing.
A total of 45 participants aged 30 to 80 years will be enrolled and assigned to one of the three treatment groups. The effectiveness of therapy will be assessed using standardized questionnaires about symptoms and quality of life, as well as microscopic evaluation of tissue samples before and after treatment.
The study seeks to determine whether platelet-rich plasma (PRP) can serve as a safe and effective first-line treatment option for vulvar lichen sclerosus and to improve our understanding of the best therapeutic approaches for this chronic disease.
Read the detailed description
Vulvar lichen sclerosus (VLS) is a chronic, progressive inflammatory dermatosis that primarily affects the skin and mucosa of the vulva and perineal region. The condition is most common in postmenopausal women and may cause severe itching, burning, pain during sexual intercourse, and, over time, scarring or anatomical changes that can significantly impair daily functioning and quality of life. If untreated, VLS may also increase the risk of developing vulvar intraepithelial neoplasia (VIN) or squamous cell carcinoma.
Despite the chronic nature of the disease, there is still no universally accepted standard of care for first-line treatment. Topical corticosteroids (such as clobetasol propionate 0.05%) are considered the mainstay of therapy, while topical calcineurin inhibitors (e.g., pimecrolimus or tacrolimus) are often used as alternatives or adjuncts in resistant cases. In recent years, regenerative methods such as platelet-rich plasma (PRP) therapy have emerged as a promising option. PRP is an autologous preparation containing a high concentration of platelets and growth factors that can stimulate tissue repair, reduce inflammation, and improve mucosal regeneration.
This open-label, non-randomized clinical study aims to evaluate and compare the therapeutic efficacy and safety of three treatment modalities in women with histopathologically confirmed vulvar lichen sclerosus:
PRP injection therapy using the Arthrex ACP Max™ Platelet-Rich Plasma System,
Topical corticosteroid therapy with clobetasol propionate 0.05% cream, and
Topical calcineurin inhibitor therapy with pimecrolimus cream.
A total of 45 participants will be recruited and assigned to one of the three treatment arms (15 per group). Clinical symptoms and quality of life will be evaluated using two validated questionnaires - the Vulvar Disease Symptom Score (VDSS) and the Dermatology Life Quality Index (DLQI) - at baseline, 3 months, and 6 months after treatment initiation. At the 6-month follow-up, a small biopsy from the vulvar area will be performed to assess histopathological changes, particularly the density of inflammatory cells.
The results of this study may help determine whether platelet-rich plasma (PRP) therapy could represent an effective and safe alternative to conventional topical treatments. Ultimately, this research could contribute to the development of more individualized and evidence-based therapeutic strategies for women suffering from vulvar lichen sclerosus.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- Platelet-Rich Plasma (PRP) Treatment, Clobetasol Propionate 0.05% Cream (Dermovate), Pimecrolimus Cream (Elidel)
- Keywords
- Vulvar Lichen Sclerosus
- 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.
Platelet-Rich Plasma (PRP) TreatmentBiological
Autologous platelet-rich plasma (5 ml) prepared using the Arthrex ACP Max™ Platelet-Rich Plasma System is injected subcutaneously and submucosally into clinically affected vulvar areas and sites of itching or pain. PRP is administered once at baseline following standard aseptic technique.
Clobetasol Propionate 0.05% Cream (Dermovate)Drug
Participants apply clobetasol propionate 0.05% cream topically twice daily for the first 3 weeks, followed by once daily for the next 3 weeks. This regimen represents standard high-potency corticosteroid therapy for vulvar lichen sclerosus.
Pimecrolimus Cream (Elidel)Drug
Participants apply pimecrolimus cream topically twice daily for 3 weeks, followed by once daily for the next 3 weeks. This regimen represents topical calcineurin inhibitor therapy for vulvar lichen sclerosus.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Plasma (PRP) Treatment | Experimental | Participants receive subcutaneous and submucosal injections of 5 ml autologous platelet-rich plasma (PRP) prepared using the Arthrex ACP Max™ system. PRP is injected into clinically affected vulvar areas and sites of itching or pain. Procedure performed once at study start. Outcomes are evaluated at baseline, 3 months, and 6 months; a vulvar biopsy is taken at 6 months. Receives: Biological: Platelet-Rich Plasma (PRP) Treatment |
| Topical High-Potency Corticosteroid | Active comparator | Participants apply clobetasol propionate 0.05% cream (Dermovate) twice daily for the first 3 weeks and once daily for the following 3 weeks. Follow-up assessments occur at baseline, 3 months, and 6 months; a vulvar biopsy is taken at 6 months. Receives: Drug: Clobetasol Propionate 0.05% Cream (Dermovate) |
| Topical Calcineurin Inhibitor | Active comparator | Participants apply pimecrolimus cream (Elidel) twice daily for 3 weeks and once daily for the following 3 weeks. Follow-up assessments occur at baseline, 3 months, and 6 months; a vulvar biopsy is taken at 6 months. Receives: Drug: Pimecrolimus Cream (Elidel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DLQI (Dermatology Life Quality Index) Score
The DLQI questionnaire assesses the impact of vulvar lichen sclerosus on patient quality of life. Scores range from 0 to 30, with higher scores indicating greater impairment. The study will measure the change in DLQI from baseline to 6 months across the three treatment groups.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (1)
Change in VDSS (Vulvar Disease Symptom Score)
The VDSS evaluates symptom severity (itching, burning, pain, dyspareunia) associated with vulvar lichen sclerosus. The study assesses changes in total VDSS score over time to compare treatment effectiveness.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
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.
- 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
- This study uses a three-arm, parallel assignment model comparing commonly used first-line therapies for vulvar lichen sclerosus. Participants are allocated into one of three non-randomized groups: (1) platelet-rich plasma (PRP) injections, (2) high-potency topical corticosteroid cream, or (3) topical calcineurin inhibitor. Each group receives a distinct intervention, and outcomes are assessed over 6 months using validated symptom and quality-of-life questionnaires and histopathological evaluation. The open-label design reflects real-world clinical practice and allows direct comparison of the effectiveness of each treatment modality.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milosz Pietrus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Milosz Pietrus, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240389
- Sponsor's protocol ID
- UJ/2025/VULIS-3T
- Other IDs
- N41/DBS/001550
- Acronym
- VULIS-3T
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the sensitive nature of vulvar biopsy samples and privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Therapeutic Outcomes in Vulvar Lichen Sclerosus Treated With Corticosteroids, Calcineurin Inhibitors, and Platelet-rich Plasma (PRP).
- ClinicalTrials.gov ID
- NCT07240389
- Acronym / sponsor ID
- VULIS-3T / UJ/2025/VULIS-3T
- Conditions
- Vulvar Lichen Sclerosus
- Keywords
- Vulvar Lichen Sclerosus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Milosz PietrusUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 20 Nov 2025 (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 chronic inflammatory skin condition that affects the vulvar area, often causing itching, burning, and pain, and may lead to scarring and narrowing of the vaginal opening. The condition significantly reduces the quality of life and may increase the risk of cancerous changes if left untreated.
This clinical study aims to evaluate and compare three commonly used treatment methods for women with biopsy-confirmed vulvar lichen sclerosus:
Topical corticosteroid therapy (clobetasol propionate 0.05%),
Topical calcineurin inhibitor therapy (pimecrolimus), and
Platelet-rich plasma (PRP) injections, which use the patient's own blood plasma rich in growth factors to support tissue healing.
A total of 45 participants aged 30 to 80 years will be enrolled and assigned to one of the three treatment groups. The effectiveness of therapy will be assessed using standardized questionnaires about symptoms and quality of life, as well as microscopic evaluation of tissue samples before and after treatment.
The study seeks to determine whether platelet-rich plasma (PRP) can serve as a safe and effective first-line treatment option for vulvar lichen sclerosus and to improve our understanding of the best therapeutic approaches for this chronic disease.
Detailed description
Vulvar lichen sclerosus (VLS) is a chronic, progressive inflammatory dermatosis that primarily affects the skin and mucosa of the vulva and perineal region. The condition is most common in postmenopausal women and may cause severe itching, burning, pain during sexual intercourse, and, over time, scarring or anatomical changes that can significantly impair daily functioning and quality of life. If untreated, VLS may also increase the risk of developing vulvar intraepithelial neoplasia (VIN) or squamous cell carcinoma.
Despite the chronic nature of the disease, there is still no universally accepted standard of care for first-line treatment. Topical corticosteroids (such as clobetasol propionate 0.05%) are considered the mainstay of therapy, while topical calcineurin inhibitors (e.g., pimecrolimus or tacrolimus) are often used as alternatives or adjuncts in resistant cases. In recent years, regenerative methods such as platelet-rich plasma (PRP) therapy have emerged as a promising option. PRP is an autologous preparation containing a high concentration of platelets and growth factors that can stimulate tissue repair, reduce inflammation, and improve mucosal regeneration.
This open-label, non-randomized clinical study aims to evaluate and compare the therapeutic efficacy and safety of three treatment modalities in women with histopathologically confirmed vulvar lichen sclerosus:
PRP injection therapy using the Arthrex ACP Max™ Platelet-Rich Plasma System,
Topical corticosteroid therapy with clobetasol propionate 0.05% cream, and
Topical calcineurin inhibitor therapy with pimecrolimus cream.
A total of 45 participants will be recruited and assigned to one of the three treatment arms (15 per group). Clinical symptoms and quality of life will be evaluated using two validated questionnaires - the Vulvar Disease Symptom Score (VDSS) and the Dermatology Life Quality Index (DLQI) - at baseline, 3 months, and 6 months after treatment initiation. At the 6-month follow-up, a small biopsy from the vulvar area will be performed to assess histopathological changes, particularly the density of inflammatory cells.
The results of this study may help determine whether platelet-rich plasma (PRP) therapy could represent an effective and safe alternative to conventional topical treatments. Ultimately, this research could contribute to the development of more individualized and evidence-based therapeutic strategies for women suffering from vulvar lichen sclerosus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study uses a three-arm, parallel assignment model comparing commonly used first-line therapies for vulvar lichen sclerosus. Participants are allocated into one of three non-randomized groups: (1) platelet-rich plasma (PRP) injections, (2) high-potency topical corticosteroid cream, or (3) topical calcineurin inhibitor. Each group receives a distinct intervention, and outcomes are assessed over 6 months using validated symptom and quality-of-life questionnaires and histopathological evaluation. The open-label design reflects real-world clinical practice and allows direct comparison of the effectiveness of each treatment modality.
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Plasma (PRP) Treatment | Experimental | Biological: Platelet-Rich Plasma (PRP) TreatmentParticipants receive subcutaneous and submucosal injections of 5 ml autologous platelet-rich plasma (PRP) prepared using the Arthrex ACP Max™ system. PRP is injected into clinically affected vulvar areas and sites of itching or pain. Procedure performed once at study start. Outcomes are evaluated at baseline, 3 months, and 6 months; a vulvar biopsy is taken at 6 months. |
| Topical High-Potency Corticosteroid | Active comparator | Drug: Clobetasol Propionate 0.05% Cream (Dermovate)Participants apply clobetasol propionate 0.05% cream (Dermovate) twice daily for the first 3 weeks and once daily for the following 3 weeks. Follow-up assessments occur at baseline, 3 months, and 6 months; a vulvar biopsy is taken at 6 months. |
| Topical Calcineurin Inhibitor | Active comparator | Drug: Pimecrolimus Cream (Elidel)Participants apply pimecrolimus cream (Elidel) twice daily for 3 weeks and once daily for the following 3 weeks. Follow-up assessments occur at baseline, 3 months, and 6 months; a vulvar biopsy is taken at 6 months. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 30 to 80 years.
- Clinical diagnosis of vulvar lichen sclerosus confirmed by histopathological examination.
- Ability and willingness to provide written informed consent for participation in the study.
- Ability to comply with study procedures, including questionnaire completion and follow-up visits at baseline, 3 months, and 6 months.
Key exclusion criteria (5 listed)
- Lack of written informed consent to participate in the study.
- Prior treatment for vulvar lichen sclerosus (any systemic or topical therapy targeted at VLS).
- Current or past vulvar neoplasia, including vulvar intraepithelial neoplasia (VIN) or vulvar carcinoma.
- Other organic or dermatologic causes of vulvar symptoms that could interfere with diagnosis or outcome evaluation.
- Any condition that, in the opinion of the investigator, would interfere with study participation, follow-up, or accurate interpretation of results.
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 |
|---|---|---|
| Platelet-Rich Plasma (PRP) TreatmentAutologous platelet-rich plasma (5 ml) prepared using the Arthrex ACP Max™ Platelet-Rich Plasma System is injected subcutaneously and submucosally into clinically affected vulvar areas and sites of itching or pain. PRP is administered once at baseline following standard aseptic technique. | Biological | Platelet-Rich Plasma (PRP) Treatment |
| Clobetasol Propionate 0.05% Cream (Dermovate)Participants apply clobetasol propionate 0.05% cream topically twice daily for the first 3 weeks, followed by once daily for the next 3 weeks. This regimen represents standard high-potency corticosteroid therapy for vulvar lichen sclerosus. | Drug | Topical High-Potency Corticosteroid |
| Pimecrolimus Cream (Elidel)Participants apply pimecrolimus cream topically twice daily for 3 weeks, followed by once daily for the next 3 weeks. This regimen represents topical calcineurin inhibitor therapy for vulvar lichen sclerosus. | Drug | Topical Calcineurin Inhibitor |
Primary outcome
Change in DLQI (Dermatology Life Quality Index) Score
Time frame: Baseline, 3 months, 6 months
The DLQI questionnaire assesses the impact of vulvar lichen sclerosus on patient quality of life. Scores range from 0 to 30, with higher scores indicating greater impairment. The study will measure the change in DLQI from baseline to 6 months across the three treatment groups.
1 secondary outcome
Change in VDSS (Vulvar Disease Symptom Score)
Time frame: Baseline, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the sensitive nature of vulvar biopsy samples and privacy considerations.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-Rich Plasma (PRP) Treatment, Clobetasol Propionate 0.05% Cream (Dermovate) and Pimecrolimus Cream (Elidel) in people with Vulvar Lichen Sclerosus, run by Milosz Pietrus at 1 site in Poland.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 20 Nov 2025. 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 Poland. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milosz Pietrus, MD PhD (+48 602 779 298, milosz.pietrus@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DLQI (Dermatology Life Quality Index) Score (time frame: Baseline, 3 months, 6 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 20 Nov 2025.