Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03665584
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2018-08-06
Brief Title:
MonaLisa Touch Laser for the Treatment of Vulvar Lichen Sclerosus
Sponsor:
Center for Vulvovaginal Disorders
Organization:
Center for Vulvovaginal Disorders
Study Overview
Official Title:
A Double Blinded Sham Controlled Trial of Fractional CO2 Laser Treatment Using the DEKA SmartXide Touch Laser System MonaLisa Touch for the Treatment of Vulvar Lichen Sclerosus
Status:
COMPLETED
Status Verified Date:
2020-11
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:
Lichen sclerosus LS is a skin condition of the external genitals vulva of women LS causes vulvar itching pain and burning In addition LS causes scarring of the vulva which may cause significant sexual dysfunction or pain Lastly 4-6 of women with LS will develop vulvar cancer
The current gold standard treatment for lichen sclerosus is potent steroids creams When used correctly steroid creams help to decrease the symptoms of itching and burning and can prevent further vulvar scarring In addition proper treatment reverses the underlying inflammation of LS and may lower the risk of getting cancer While useful steroid creams may have serious side effects that include thinning of the skin fungal infections and lowering the immune system
Recently microablative fractional CO 2 laser treatment FxCO 2 SmartXide 2 V 2 LR laser system for MonaLisa Touch DEKA Florence Italy has been proposed for the management of LS Specifically two small studies demonstrated that FxCO 2 therapy appears to be a promising treatment modality to treat lichen sclerosus These studies demonstrated that FxCO 2 treatment may stimulate tissue healing in LS Furthermore by reducing inflammation the clinical symptoms of LS such as intense itching and burning were improved While these studies showed good success these studies were limited because of their small size and lack of sham fake treatment control
The purpose of this study is to look at the efficacy how well it works and the safety of the FxCO 2 laser treatment laser energy emitted for LS as compared to a sham treatment very minimal laser energy will be emitted
The current gold standard treatment for lichen sclerosus is potent steroids creams When used correctly steroid creams help to decrease the symptoms of itching and burning and can prevent further vulvar scarring In addition proper treatment reverses the underlying inflammation of LS and may lower the risk of getting cancer While useful steroid creams may have serious side effects that include thinning of the skin fungal infections and lowering the immune system
Recently microablative fractional CO 2 laser treatment FxCO 2 SmartXide 2 V 2 LR laser system for MonaLisa Touch DEKA Florence Italy has been proposed for the management of LS Specifically two small studies demonstrated that FxCO 2 therapy appears to be a promising treatment modality to treat lichen sclerosus These studies demonstrated that FxCO 2 treatment may stimulate tissue healing in LS Furthermore by reducing inflammation the clinical symptoms of LS such as intense itching and burning were improved While these studies showed good success these studies were limited because of their small size and lack of sham fake treatment control
The purpose of this study is to look at the efficacy how well it works and the safety of the FxCO 2 laser treatment laser energy emitted for LS as compared to a sham treatment very minimal laser energy will be emitted
Detailed Description:
Lichen sclerosus LS is a chronic cutaneous disorder affecting approximately one in seventy women Presenting symptoms may include intense pruritus pain burning and severe dyspareunia This disorder may affect any area of the skin but has a notable predilection for the anogenital skin Extra-genital involvement is infrequent affecting only 11 of women with LS Affected females outnumber affect males by 101 There is bimodal peak incidence in premenarchal girls and menopausal women with an average age of onset of 51 years of age
The typical lesions of LS are white plaques and papules often with areas of ecchymosis excoriation and ulceration Often there is destruction of the vulva architecture with scarring of the clitoral prepuce resorption of the labia minora and narrowing of the introitus Four to six percent of women with LS will develop vulvar carcinoma The histopathologic changes of LS are distinctive and make biopsy a very useful diagnostic tool Characteristic pathologic finding include hyperkeratosis of the epidermis epidermal atrophy with loss of rete ridges homogenization of the collagen in the upper dermis and a lichenoid band-like inflammatory infiltrate in the dermis While there is no known cure for LS the current gold standard treatment is ultra-potent corticosteroids When properly administered topical ultra-potent corticosteroids help to resolve the symptoms of pruritus and burning and can prevent further vulvar scarring In addition proper treatment reverses the underlying histopathologic changes of LS and preliminary data shows that the risk of malignant transformation also declines
Although treatment with topical corticosteroids is effective topical corticosteroids may have serious local and systemic side effects including dermal thinning skin atrophy superimposed infections rebound dermatitis and adrenal insufficiency Due to these side effects long- term use of corticosteroids for the treatment of vulvar lichen sclerosus may be inadvisable Therefore a safe and effective alternative intervention is needed for this disorder
Recently microablative fractional CO 2 laser SmartXide 2 V 2 LR CO 2 laser system for MonaLisa Touch DEKA Florence Italy has been proposed for the management of LS This type of laser has a wavelength of 10600 nm that allows a superficial microablative effect in soft tissues and a pulsed beam that protects the tissues from possible overheating damage The laser beam is delivered to the tissue in a fractional manner creating small spots called DOTs alternating parts of tissue treated and not treated The size of each DOT is set by the manufacturer at 150 - 200 μm Moreover it has a DEKA pulse D-pulse mode that consists of two parts a constant high energy peak power for rapid superficial evaporation of the atrophic epithelium with low water content and b lower peak power with longer emission times that allows the energy heat to penetrate deeper in the epithelium This D-pulse mode combined with DOTs remodels the connective tissue via the production of heat shock protein 47 and produces new collagenfibroblasts and ground matrix
Recently two small studies demonstrated that fractional CO 2 laser FxCO 2 therapy appears to be a promising treatment modality to treat lichen sclerosus These studies demonstrated that FxCO 2 treatment may stimulate protein synthesis accelerate tissue reconstruction and decrease lichenification Furthermore after elimination of local inflammation the stimulus of nerve endings was reduced so the clinical manifestations of LS such as intense vulvar pruritus and burning were improved
The typical lesions of LS are white plaques and papules often with areas of ecchymosis excoriation and ulceration Often there is destruction of the vulva architecture with scarring of the clitoral prepuce resorption of the labia minora and narrowing of the introitus Four to six percent of women with LS will develop vulvar carcinoma The histopathologic changes of LS are distinctive and make biopsy a very useful diagnostic tool Characteristic pathologic finding include hyperkeratosis of the epidermis epidermal atrophy with loss of rete ridges homogenization of the collagen in the upper dermis and a lichenoid band-like inflammatory infiltrate in the dermis While there is no known cure for LS the current gold standard treatment is ultra-potent corticosteroids When properly administered topical ultra-potent corticosteroids help to resolve the symptoms of pruritus and burning and can prevent further vulvar scarring In addition proper treatment reverses the underlying histopathologic changes of LS and preliminary data shows that the risk of malignant transformation also declines
Although treatment with topical corticosteroids is effective topical corticosteroids may have serious local and systemic side effects including dermal thinning skin atrophy superimposed infections rebound dermatitis and adrenal insufficiency Due to these side effects long- term use of corticosteroids for the treatment of vulvar lichen sclerosus may be inadvisable Therefore a safe and effective alternative intervention is needed for this disorder
Recently microablative fractional CO 2 laser SmartXide 2 V 2 LR CO 2 laser system for MonaLisa Touch DEKA Florence Italy has been proposed for the management of LS This type of laser has a wavelength of 10600 nm that allows a superficial microablative effect in soft tissues and a pulsed beam that protects the tissues from possible overheating damage The laser beam is delivered to the tissue in a fractional manner creating small spots called DOTs alternating parts of tissue treated and not treated The size of each DOT is set by the manufacturer at 150 - 200 μm Moreover it has a DEKA pulse D-pulse mode that consists of two parts a constant high energy peak power for rapid superficial evaporation of the atrophic epithelium with low water content and b lower peak power with longer emission times that allows the energy heat to penetrate deeper in the epithelium This D-pulse mode combined with DOTs remodels the connective tissue via the production of heat shock protein 47 and produces new collagenfibroblasts and ground matrix
Recently two small studies demonstrated that fractional CO 2 laser FxCO 2 therapy appears to be a promising treatment modality to treat lichen sclerosus These studies demonstrated that FxCO 2 treatment may stimulate protein synthesis accelerate tissue reconstruction and decrease lichenification Furthermore after elimination of local inflammation the stimulus of nerve endings was reduced so the clinical manifestations of LS such as intense vulvar pruritus and burning were improved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None