Vulvar Lichen SclerosusPhase 1/2NCT04967170
A Study to Evaluate Platelet Rich Plasma to Treat Vulvar Lichen Sclerosus
A Phase 1/2 study testing Autologous Platelet-Rich Plasma (PRP) in people with Vulvar Lichen Sclerosus, run by Jennifer R. Arthurs at 1 site in United States.
Trial summary
The purposes of this study are to determine the safety and feasibility of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus, and to determine the efficacy of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- Autologous Platelet-Rich Plasma (PRP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to 12 Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, ages 18 years and greater.
- Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit.
- Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
- Diagnosis of Lichen Sclerosus.
- On a maintenance regimen of topical clobetasol for Lichen Sclerosus. Maintenance is defined as use of topical clobetasol 3 or fewer days per week. For patients with a new diagnosis of Lichen Sclerosus, they will complete 6 weeks of topical clobetasol ointment twice daily prior to enrollment in the study with transition to a maintenance regimen during study.
- Completed general physical evaluation with primary care provider within 12 months of enrollment.
- Full understanding of the requirements of the study and willingness to comply with protocol.
- Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure
Who cannot join
- Pregnant or nursing, or planning on becoming pregnant during the study period.
- Clinically significant abnormal hematology (complete blood count with differential).
- Taking anticoagulant medications (e.g., warfarin, heparin) or clopidogrel (Plavix).
- Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
- On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids.
- Using topical steroids on affected area and unable to stop for the 6 week washout period prior to beginning the study. Topical steroid use will be exclusionary throughout week 12 of the study for patients randomized to receive PRP.
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- Current tobacco product use, including nicotine patch or other nicotine products.
- Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis.
- Clinically significant cardiovascular (e.g., history of myocardial infarction, congestive heart failure or uncontrolled hypertension > 90 mmHg diastolic and/or 180 mmHg systolic), neurologic (e.g., stroke, TIA) renal, hepatic, or endocrine disease (e.g., diabetes).
- History of cancer/malignancy with the exception of adequately treated basal cell or squamous cell carcinoma of the skin within the last 5 years.
- History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy.
- Participation in a study of an experimental drug or medical device within 3 months of study enrollment.
- Known allergy to local anesthetics of other components of the study drug.
- History of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have use of medical marijuana within 30 days of study entry.
- Any illness or condition which, in the investigators' judgement will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Randomized, Blinded, Controlled Study Evaluating Autologous Platelet-Rich Plasma for the Treatment of Vulvar Lichen Sclerosus
The purposes of this study are to determine the safety and feasibility of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus, and to determine the efficacy of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- Autologous Platelet-Rich Plasma (PRP), Sham Procedure
- 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.
Autologous Platelet-Rich Plasma (PRP)Biological
Two intralesional injections of approximately 5-6mL given approximately 6 weeks apart
Sham ProcedureOther
Intralesional needle insertion without any injectate.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma Group | Experimental | Subject diagnosed with vulvar lichen sclerosus will receive Autologous Platelet-Rich Plasma (PRP) Receives: Biological: Autologous Platelet-Rich Plasma (PRP) |
| Sham Procedure Group | Sham comparator | Subject diagnosed with vulvar lichen sclerosus will receive sham procedure of intralesional needle insertion without any injectate administered. Receives: Other: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Number of adverse events reported
Measured: 6 months
Secondary outcomes (1)
Change in patient-administered symptom score on Clinical Scoring System for Lichen Sclerosus
Measured using the self-reported Clinical Scoring System for Lichen Sclerosus questionnaire that scores symptoms from 0 (no complaints) to 10 (extreme complaints)
Measured: Baseline, 1 week, 6 weeks, 12 weeks, 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 posted19 Jul 2021
- Study start19 Jan 2022
- Primary completion12 Dec 2025
- Study completion12 Dec 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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer R. Arthurs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer R. Arthurs, Mayo Clinic
- Investigators
- Katherine Bodiford, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967170
- Sponsor's protocol ID
- 20-009396
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Randomized, Blinded, Controlled Study Evaluating Autologous Platelet-Rich Plasma for the Treatment of Vulvar Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT04967170
- Acronym / sponsor ID
- 20-009396
- Conditions
- Vulvar Lichen Sclerosus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jennifer R. ArthursUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 19 Jul 2021 (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.
The purposes of this study are to determine the safety and feasibility of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus, and to determine the efficacy of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma Group | Experimental | Biological: Autologous Platelet-Rich Plasma (PRP)Subject diagnosed with vulvar lichen sclerosus will receive Autologous Platelet-Rich Plasma (PRP) |
| Sham Procedure Group | Sham comparator | Other: Sham ProcedureSubject diagnosed with vulvar lichen sclerosus will receive sham procedure of intralesional needle insertion without any injectate administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female, ages 18 years and greater.
- Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit.
- Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
- Diagnosis of Lichen Sclerosus.
- On a maintenance regimen of topical clobetasol for Lichen Sclerosus. Maintenance is defined as use of topical clobetasol 3 or fewer days per week. For patients with a new diagnosis of Lichen Sclerosus, they will complete 6 weeks of topical clobetasol ointment twice daily prior to enrollment in the study with transition to a maintenance regimen during study.
Key exclusion criteria (15 listed)
- Pregnant or nursing, or planning on becoming pregnant during the study period.
- Clinically significant abnormal hematology (complete blood count with differential).
- Taking anticoagulant medications (e.g., warfarin, heparin) or clopidogrel (Plavix).
- Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
- On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids.
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 |
|---|---|---|
| Autologous Platelet-Rich Plasma (PRP)Two intralesional injections of approximately 5-6mL given approximately 6 weeks apart | Biological | Platelet Rich Plasma Group |
| Sham ProcedureIntralesional needle insertion without any injectate. | Other | Sham Procedure Group |
Primary outcome
Incidence of adverse events
Time frame: 6 months
Number of adverse events reported
1 secondary outcome
Change in patient-administered symptom score on Clinical Scoring System for Lichen Sclerosus
Time frame: Baseline, 1 week, 6 weeks, 12 weeks, 3 months, 6 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 22 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Katherine Bodiford, MD principal investigator
Mayo Clinic
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 Autologous Platelet-Rich Plasma (PRP) in people with Vulvar Lichen Sclerosus, run by Jennifer R. Arthurs at 1 site in United States.
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 8 inclusion and 15 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 22 Jul 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 United States. 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?
Incidence of adverse events (time frame: 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 22 Jul 2026.