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NCT05364515: PRGF
Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva
Phase 3 trial testing PRGF in Lichen Sclerosus of Vulva. Withdrawn.
15 February 2024
Quick facts
| Lead sponsor | Fundación Eduardo Anitua |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 23 December 2021 |
| Primary completion | 15 February 2024 |
| Estimated completion | 15 February 2024 |
Drugs / interventions tested
- PRGF — full drug profile →
- Clobetasol Propionate (CLOBETASOL PROPIONATE) — full drug profile →
Conditions studied
- Lichen Sclerosus of Vulva — all drugs for Lichen Sclerosus of Vulva →
Sponsor
Fundación Eduardo Anitua — full company profile →
Who can join
18 and older, female only, with Lichen Sclerosus of Vulva. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Lichen sclerosus: The 2023 update.
De Luca DA, Papara C, Vorobyev A, Staiger H, et al · · 2023 · cited 94× · PMID 36873861 · DOI 10.3389/fmed.2023.1106318
Verify or expand the search:
- PubMed search for NCT05364515
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other Fundación Eduardo Anitua trials
Trials by the same sponsor.
- NCT04929743 — Randomized Clinical Trial to Evaluate the Predictability of 5.5 mm Dental Implants · NA · completed
- NCT04927819 — Extra-short vs. Non-extra-short Dental Implants Splinted on the Same Prosthesis · recruiting
- NCT04945629 — Plasma Rich in Growth Factors in the Preservation of the Alveolar Ridge After Simple Molar Tooth Extractions. · Phase 3 · completed
- NCT04543292 — Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys. · NA · completed
- NCT04093583 — Randomized Clinical Trial, Conventional Treatment-controlled, Studying the Efficacy of Plasma Rich in Growth Factor (PRG · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05364515 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundación Eduardo Anitua
- Last refreshed: 27 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05364515.
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