Ignite Creation Date:
2024-05-06 @ 9:21 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02966925
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2016-11-10
Brief Title:
Autologous Platelet Concentrate Combined to Hyaluronic Acid Obtained With Cellular Matrix BCT-HA Kit and Vulvovaginal Dryness
Sponsor:
Regen Lab SA
Organization:
Regen Lab SA
Study Overview
Official Title:
Evaluation of the Benefit of the Use of Platelet-Rich Plasma PRP Combined to Hyaluronic Acid HA for Vulvovaginal Dryness
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vulvovaginal irritation is a frequent complaint among postmenopausal women Common symptoms of vaginal atrophy include dryness itching burning and dyspareunia
This pilot study will assess the efficacy of platelet-rich plasma PRP combined to hyaluronic acid HA to relieve vulvovaginal dryness in patients who cannot benefit from reference treatments hormonal therapiesTo achieve this 20 patients suffering from vulvovaginal dryness will be treated with one session of injections in the vulva the posterior vaginal wall and the perineum and followed-up for 6 months Improvement of vaginal dryness will be primarily appreciated through Friedmann score and pH value and secondarily through the Female Sexual Function Index FSFI as measured at baseline and 1 3 and 6 months after the treatment
This pilot study will assess the efficacy of platelet-rich plasma PRP combined to hyaluronic acid HA to relieve vulvovaginal dryness in patients who cannot benefit from reference treatments hormonal therapiesTo achieve this 20 patients suffering from vulvovaginal dryness will be treated with one session of injections in the vulva the posterior vaginal wall and the perineum and followed-up for 6 months Improvement of vaginal dryness will be primarily appreciated through Friedmann score and pH value and secondarily through the Female Sexual Function Index FSFI as measured at baseline and 1 3 and 6 months after the treatment
Detailed Description:
A treatment relying on the association of both platelet-rich plasma PRP and hyaluronic acid HA could represent a therapeutical alternative for patients suffering from vulvovaginal dryness who cannot be treated with hormone therapy
Indeed hyaluronic acid is widely distributed in all tissues and most particularly in vulvovaginal tissues Due to its hydrating and healing properties HA plays a key role in tissue regeneration facilitating the entry of a large number and variety of cells into the injured area reconstructing in this way an extracellular matrix capable of supporting the proliferation and differentiation of cells for tissue regeneration In additionits ability to retain water at up to 1000x its weight makes it the ideal substance for ensuring hydration of the skin Thus the gynaecological use of HA could be a promising therapeutic option for the treatment of vulvovaginal dryness
On the other hand numerous studies have shown the role of PRP in the healing of soft and hard tissues PRP is an autologous preparation from the patients own blood playing the role of growth factors reservoir during treatment Indeed platelet activation induces alpha-granules degranulation releasing synthesized pre-packaged growth factors Once released growth factors induce different cell signaling cascades that activate angiogenesis cell proliferation cell differentiation and new matrix synthesis for tissue regeneration A recent clinical study showed that PRP could significantly reduce sexual distress of patients suffering from dyspareunia and suggests that PRP could improve vaginal vascularization and physiologic responsivness in patients with vaginal atrophy
In the present pilot study a combination of PRPHA obtained with Cellular Matrix will be injected in the vulva vaginal wall and perineum of women with vulvovaginal dryness Outcomes will be compared before and at various timepoints after treatment
Indeed hyaluronic acid is widely distributed in all tissues and most particularly in vulvovaginal tissues Due to its hydrating and healing properties HA plays a key role in tissue regeneration facilitating the entry of a large number and variety of cells into the injured area reconstructing in this way an extracellular matrix capable of supporting the proliferation and differentiation of cells for tissue regeneration In additionits ability to retain water at up to 1000x its weight makes it the ideal substance for ensuring hydration of the skin Thus the gynaecological use of HA could be a promising therapeutic option for the treatment of vulvovaginal dryness
On the other hand numerous studies have shown the role of PRP in the healing of soft and hard tissues PRP is an autologous preparation from the patients own blood playing the role of growth factors reservoir during treatment Indeed platelet activation induces alpha-granules degranulation releasing synthesized pre-packaged growth factors Once released growth factors induce different cell signaling cascades that activate angiogenesis cell proliferation cell differentiation and new matrix synthesis for tissue regeneration A recent clinical study showed that PRP could significantly reduce sexual distress of patients suffering from dyspareunia and suggests that PRP could improve vaginal vascularization and physiologic responsivness in patients with vaginal atrophy
In the present pilot study a combination of PRPHA obtained with Cellular Matrix will be injected in the vulva vaginal wall and perineum of women with vulvovaginal dryness Outcomes will be compared before and at various timepoints after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None