Ignite Creation Date:
2024-05-06 @ 4:31 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05010421
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2021-07-16
Brief Title:
Laser vs Clobetasol for Lichen Sclerosus
Sponsor:
Ruhr University of Bochum
Organization:
Ruhr University of Bochum
Study Overview
Official Title:
CO2 Non-ablative Laser Versus Topical Clobetasol for Lichen Sclerosus a Prospective Open-label Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Lichen sclerosus LS is a common autoimmune disease of the genital skin It affects 1900 women with an age peak in the sixth decade of life and is manifested by chronic inflammation of the genital perineal and perianal areas associated with itching burning pain and soreness In addition LS is associated with an increased risk of vulvar cancer
Treatment options for LS include topical steroids such as clobetasol immunomodulators such as tacrolimus and non-ablative laser treatment Although both treatments are well documented and used in clinical practice direct comparative studies of the efficacy of topical corticosteroids versus laser treatment in women with LS are rare For example a PubMed literature search search date 2021-03-14 search terms lichen sclerosus laser corticosteroids steroids clobetasol randomized identified only a single randomized trial with limited power
Given the available evidence further high-quality studies are needed to define the superiorityinferiority of the different available treatment options such as nonablative lasers and topical corticosteroids
Therefore in this prospective randomized open-label comparative study treatment success after 3 courses of non-ablative treatment with CO2 laser every 14 days will be compared with treatment success after topical application of clobetasol 005 over 3 months daily in the first month every other day in month 2 and 3 timesweek during month 3 at the time point 3 months after treatment initiation
Treatment options for LS include topical steroids such as clobetasol immunomodulators such as tacrolimus and non-ablative laser treatment Although both treatments are well documented and used in clinical practice direct comparative studies of the efficacy of topical corticosteroids versus laser treatment in women with LS are rare For example a PubMed literature search search date 2021-03-14 search terms lichen sclerosus laser corticosteroids steroids clobetasol randomized identified only a single randomized trial with limited power
Given the available evidence further high-quality studies are needed to define the superiorityinferiority of the different available treatment options such as nonablative lasers and topical corticosteroids
Therefore in this prospective randomized open-label comparative study treatment success after 3 courses of non-ablative treatment with CO2 laser every 14 days will be compared with treatment success after topical application of clobetasol 005 over 3 months daily in the first month every other day in month 2 and 3 timesweek during month 3 at the time point 3 months after treatment initiation
Detailed Description:
Lichen sclerosus LS is a common autoimmune disorder of the genital skin It affects 1900 women with an age peak in the sixth decade of life LS is a chronic inflammatory condition affecting the genital perineal and perianal areas and causes itching burning pain and soreness Histologically LS is characterized by epidermal atrophy hyperkeratosis follicular plugging degeneration of the basal layer and subepidermal hyalinization of collagen in the papillary dermis with a lymphocytic infiltrate Affected women typically suffer significant long-term genital damage including scarring fusion of the vulval labia narrowing of the vaginal opening dyspareunia and burying of the clitoris In addition LS is associated with an increased risk of vulvar cancer
Treatment options of LS include topical steroids such as clobetasol topical immunomodulators such as tacrolimus and non-ablative laser treatment In a systematic review of the literature with 7 studies and 249 participants clobetasol achieved improvement rates and remission rates of 70 to 89 and 20 to 35 respectively In comparison non-ablative laser treatment leads to significant improvements in vulvar itching dryness pain and dyspareunia in 50 to 85 of women with remission rates of up to 80 after 14 years of follow-up Although both treatments are well documented and used in clinical practice direct comparative studies assessing the efficacy of topical corticosteroids versus laser treatment in women with LS are rare For example in a PubMed literature search search date 2021-03-14 search terms lichen sclerosus laser corticosteroids steroids clobetasol randomized only one randomized trial was identified In this study the authors included 40 women with LS and compared 3 applications of non-ablative laser 2 weeks apart with 4 weeks of twice daily 2 weeks once daily 1 week and every other day 1 week of topical clobetasol 005 cream After 3 months of treatment laser-treated women had a significantly higher sum score including burning itching and pain measured on an 11-step visual analogue scale VAS Both treatments demonstrated histological improvement with reductions of inflammatory hallmarks in skin biopsies
Given this body of evidence more high-quality studies are needed to define the superiorityinferiority of the different available treatment options such as non-ablative laser and topical corticosteroids Therefore a prospective randomized trial comparing non-ablative CO2 laser treatment and topical clobetasol 005 will be conducted The aim of this prospective randomized open-label comparative trial is to establish or refute the superiority of 3 courses of non-ablative treatment by CO2 laser every 14 days compared to topical clobetasol 005 daily in month 1 every other day in month 2 and 3 timesweek in month 3 for 3 months The primary endpoint of this study is a sum score including the pathognomonic symptoms of LS namely vulvar burning itching and pain each measured on an 11-step VAS Secondary endpoints will include the physician-scored rate of visual improvement measured on an 11-item VAS side effects and patient-reported outcomes such as subjective overall improvement general satisfaction and quality of life measured by a validated questionnaire for vulval disorders ie the VDQI Vulval Disease Quality of Life Index
Treatment options of LS include topical steroids such as clobetasol topical immunomodulators such as tacrolimus and non-ablative laser treatment In a systematic review of the literature with 7 studies and 249 participants clobetasol achieved improvement rates and remission rates of 70 to 89 and 20 to 35 respectively In comparison non-ablative laser treatment leads to significant improvements in vulvar itching dryness pain and dyspareunia in 50 to 85 of women with remission rates of up to 80 after 14 years of follow-up Although both treatments are well documented and used in clinical practice direct comparative studies assessing the efficacy of topical corticosteroids versus laser treatment in women with LS are rare For example in a PubMed literature search search date 2021-03-14 search terms lichen sclerosus laser corticosteroids steroids clobetasol randomized only one randomized trial was identified In this study the authors included 40 women with LS and compared 3 applications of non-ablative laser 2 weeks apart with 4 weeks of twice daily 2 weeks once daily 1 week and every other day 1 week of topical clobetasol 005 cream After 3 months of treatment laser-treated women had a significantly higher sum score including burning itching and pain measured on an 11-step visual analogue scale VAS Both treatments demonstrated histological improvement with reductions of inflammatory hallmarks in skin biopsies
Given this body of evidence more high-quality studies are needed to define the superiorityinferiority of the different available treatment options such as non-ablative laser and topical corticosteroids Therefore a prospective randomized trial comparing non-ablative CO2 laser treatment and topical clobetasol 005 will be conducted The aim of this prospective randomized open-label comparative trial is to establish or refute the superiority of 3 courses of non-ablative treatment by CO2 laser every 14 days compared to topical clobetasol 005 daily in month 1 every other day in month 2 and 3 timesweek in month 3 for 3 months The primary endpoint of this study is a sum score including the pathognomonic symptoms of LS namely vulvar burning itching and pain each measured on an 11-step VAS Secondary endpoints will include the physician-scored rate of visual improvement measured on an 11-item VAS side effects and patient-reported outcomes such as subjective overall improvement general satisfaction and quality of life measured by a validated questionnaire for vulval disorders ie the VDQI Vulval Disease Quality of Life Index
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None