Lichen Sclerosus of VulvaPhase 3PRGFNCT05364515
Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva
A Phase 3 study testing PRGF and Clobetasol Propionate in people with Lichen Sclerosus of Vulva, run by Fundación Eduardo Anitua.
Trial summary
Lichen sclerosus is a chronic dermatosis of the skin and semimucous membranes, characterized by the presence of well-defined atrophic white papules or plaques, which appear mainly on the skin of the anogenital region of both sexes, and less frequently on the skin of the trunk. , mainly affecting postmenopausal women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lichen Sclerosus of Vulva
- What is being tested?
- PRGF and Clobetasol Propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 Dec 2021to 15 Feb 2024
- Phase
- Phase 3
- 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
- Age >18 years
- Woman with symptoms associated with LEA confirmed by histological study
- Being 1 month without prior treatment in the affected area as a washing period
- Availability of observation during the treatment period
- Signature of the informed consent
Who cannot join
- Acute somatic disease
- Infection in the intervention area or active systemic infection
- History of cancerous or precancerous lesions in the intervention area
- In active treatment with other local treatments in the intervention area
- Under active treatment with immunosuppressants and/or anticoagulants
- History of allergies to blood derivatives
Show all 14Show fewer
- Previous diagnosis of coagulopathies
- Regular and continuous treatment with NSAIDs
- Positive markers for HCV, AfHBs, HIV-I/II or PT
- Pregnancy or women of childbearing age not taking contraceptive measures
- Lactating women
- Treatment with monoclonal antibodies
- Liver failure
- Any inability to participate in the study
About this study
Official title: Randomized Clinical Trial, Controlled to Conventional Treatment, to Evaluate the Efficacy of Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva
Lichen sclerosus is a chronic dermatosis of the skin and semimucous membranes, characterized by the presence of well-defined atrophic white papules or plaques, which appear mainly on the skin of the anogenital region of both sexes, and less frequently on the skin of the trunk. , mainly affecting postmenopausal women. There is no absolutely effective treatment. Only potent topical corticosteroids control symptoms and improve outcomes, although prolonged use can increase skin atrophy. In severe vulvar lesions, 0.05% clobetasol propionate is indicated, followed by a less potent topical corticosteroid. Relapses often occur if treatment is discontinued altogether, but respond well to reintroduction of treatment.
Plasma Rich in Growth Factors (PRGF®) is a mixture of autologous proteins, prepared from a certain volume of platelet-rich plasma obtained from a small volume of blood, which does not contain leukocytes. To date, there have been no studies evaluating PRGF® treatment in vulvar lichen sclerosus. However, there are several publications that assess the efficacy of PRPs as a treatment for vulvar lichen sclerosus. This clinical study has been designed with the aim of evaluating the efficacy of PRGF® in reducing the main symptoms of vaginal lichen sclerosus atrophicus.
- Conditions
- Lichen Sclerosus of Vulva
- Being tested
- PRGF, Clobetasol Propionate
- 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.
PRGFDrug
Plasma Rich in Growth Factors (PRGF) is a mixture of proteins and growth factors obtained from the blood of the patient.
Four PRGF infiltrations (two weeks between each infiltration). Then, application of topical PRGF serum (on alternate basis)
Clobetasol PropionateDrug
0.05 propionate clobetasol: daily (first month), alternate (second moth), twice per week (from third month)
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Active comparator | 0.05% Clobetasol propionate Receives: Drug: Clobetasol Propionate |
| PRGF | Experimental | 0.05% Clobetasol propionate + PRGF
PRGF: 4 infiltrations (first two months) + topical administration (from third month) Receives: Drug: PRGF; Drug: Clobetasol Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of quality of life measured by Skindex-29 index
Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome
Measured: 6 months
Evolution of quality of life measured by Skindex-29 index
Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome
Measured: 8 months
Secondary outcomes (10)
Evolution of quality of life measured by Skindex-29 index
Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome
Measured: 1 and 3 months
Evolution of response to treatment at 1, 3, 6 and 8 months through the clinical scale of vulvar lichen sclerosus (CSS)
Values: from 0 to 40. Lower scores mean a better outcome.
Measured: 1, 3, 6 and 8 months
Evolution of pain at 1, 3, 6 and 8 months measured through the visual analog pain scale (VAS)
Values: from 0 to 40. Lower scores mean a better outcome.
Measured: 1, 3, 6 and 8 months
Evolution of the improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I)
Evolution of the improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I)
Measured: 1, 3, 6 and 8 months
Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA)
Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA)
Measured: 1, 3, 6 and 8 months
Frequency of recurrences at 6 and 8 months of treatment
Frequency of recurrences at 6 and 8 months of treatment
Measured: 6 and 8 months
Frequency of complications
Frequency of complications
Measured: 1, 3, 6 and 8 months
Platelet concentration
Platelet concentration measurement in whole blood and PRGF fraction
Measured: 0 months
Platelet recovery
Platelet enrichment (PRGF vs. whole blood)
Measured: 0 months
Presence of leukocyte
% of leukocyte in PRGF fraction
Measured: 0 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start23 Dec 2021
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Why it stopped: The PI left the participating center and, due to the care load of the service to which she belonged, no clinician was able to take charge of the clinical trial. The clinical trial was never started, no participating subjects were included.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Sclerosus of VulvaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Eduardo Anitua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364515
- Sponsor's protocol ID
- BTIIMD-01-EC/217LIQUEN
- Acronym
- PRGF
- Status last verified
- Feb 2025
- First submitted
- 12 Apr 2022
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial, Controlled to Conventional Treatment, to Evaluate the Efficacy of Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva
- ClinicalTrials.gov ID
- NCT05364515
- Acronym / sponsor ID
- PRGF / BTIIMD-01-EC/217LIQUEN
- Conditions
- Lichen Sclerosus of Vulva
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI left the participating center and, due to the care load of the service to which she belonged, no clinician was able to take charge of the clinical trial. The clinical trial was never started, no participating subjects were included.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundación Eduardo AnituaUniversity, hospital or other
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 6 May 2022 (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.
Lichen sclerosus is a chronic dermatosis of the skin and semimucous membranes, characterized by the presence of well-defined atrophic white papules or plaques, which appear mainly on the skin of the anogenital region of both sexes, and less frequently on the skin of the trunk. , mainly affecting postmenopausal women. There is no absolutely effective treatment. Only potent topical corticosteroids control symptoms and improve outcomes, although prolonged use can increase skin atrophy. In severe vulvar lesions, 0.05% clobetasol propionate is indicated, followed by a less potent topical corticosteroid. Relapses often occur if treatment is discontinued altogether, but respond well to reintroduction of treatment.
Plasma Rich in Growth Factors (PRGF®) is a mixture of autologous proteins, prepared from a certain volume of platelet-rich plasma obtained from a small volume of blood, which does not contain leukocytes. To date, there have been no studies evaluating PRGF® treatment in vulvar lichen sclerosus. However, there are several publications that assess the efficacy of PRPs as a treatment for vulvar lichen sclerosus. This clinical study has been designed with the aim of evaluating the efficacy of PRGF® in reducing the main symptoms of vaginal lichen sclerosus atrophicus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Active comparator | Drug: Clobetasol Propionate0.05% Clobetasol propionate |
| PRGF | Experimental | Drug: PRGF, Drug: Clobetasol Propionate0.05% Clobetasol propionate + PRGF PRGF: 4 infiltrations (first two months) + topical administration (from third month) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years
- Woman with symptoms associated with LEA confirmed by histological study
- Being 1 month without prior treatment in the affected area as a washing period
- Availability of observation during the treatment period
- Signature of the informed consent
Key exclusion criteria (14 listed)
- Acute somatic disease
- Infection in the intervention area or active systemic infection
- History of cancerous or precancerous lesions in the intervention area
- In active treatment with other local treatments in the intervention area
- Under active treatment with immunosuppressants and/or anticoagulants
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 |
|---|---|---|
| PRGFPlasma Rich in Growth Factors (PRGF) is a mixture of proteins and growth factors obtained from the blood of the patient. Four PRGF infiltrations (two weeks between each infiltration). Then, application of topical PRGF serum (on alternate basis) | Drug | PRGF |
| Clobetasol Propionate0.05 propionate clobetasol: daily (first month), alternate (second moth), twice per week (from third month) | Drug | Conventional treatment, PRGF |
Primary outcome
Evolution of quality of life measured by Skindex-29 index
Time frame: 6 months
Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome
Evolution of quality of life measured by Skindex-29 index
Time frame: 8 months
Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome
10 secondary outcomes
Evolution of quality of life measured by Skindex-29 index
Time frame: 1 and 3 months
Evolution of response to treatment at 1, 3, 6 and 8 months through the clinical scale of vulvar lichen sclerosus (CSS)
Time frame: 1, 3, 6 and 8 months
Evolution of pain at 1, 3, 6 and 8 months measured through the visual analog pain scale (VAS)
Time frame: 1, 3, 6 and 8 months
Evolution of the improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I)
Time frame: 1, 3, 6 and 8 months
Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA)
Time frame: 1, 3, 6 and 8 months
Frequency of recurrences at 6 and 8 months of treatment
Time frame: 6 and 8 months
Frequency of complications
Time frame: 1, 3, 6 and 8 months
Platelet concentration
Time frame: 0 months
Platelet recovery
Time frame: 0 months
Presence of leukocyte
Time frame: 0 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRGF and Clobetasol Propionate in people with Lichen Sclerosus of Vulva, run by Fundación Eduardo Anitua.
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 5 inclusion and 14 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: withdrawn, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evolution of quality of life measured by Skindex-29 index (time frame: 6 months). The study lists 2 primary outcomes in all. 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 27 Feb 2025.