Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional treatment | Active Comparator | 0.05% Clobetasol propionate |
|
| PRGF | Experimental | 0.05% Clobetasol propionate + PRGF PRGF: 4 infiltrations (first two months) + topical administration (from third month) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRGF | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007724 | Vulvar Lichen Sclerosus |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Clobetasol Propionate | Drug | 0.05 propionate clobetasol: daily (first month), alternate (second moth), twice per week (from third month) |
|
Values: from 0 to 40. Lower scores mean a better outcome. |
| 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. | 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) | 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) | 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 | 6 and 8 months |
| Frequency of complications | Frequency of complications | 1, 3, 6 and 8 months |
| Platelet concentration | Platelet concentration measurement in whole blood and PRGF fraction | 0 months |
| Platelet recovery | Platelet enrichment (PRGF vs. whole blood) | 0 months |
| Presence of leukocyte | % of leukocyte in PRGF fraction | 0 months |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011083 |
| Polycyclic Compounds |