Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00494351
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2007-06-27
Brief Title:
Study on the Effect of NdYag Laser for the Treatment of Hidradenitis Suppurativa
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Prospective Controlled Study of the Efficacy of NdYag for Hidradenitis Suppurativa
Status:
COMPLETED
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:
Determination of the short and long term efficacy of NdYag laser for treatment of Hidradenitis suppurativa which is an inflamed deeper follicular disorders
Determination of patient tolerance of discomfort associated with NdYag laser treatment for Hidradenitis suppurativa
Determination of the impact of this condition on quality of life and if there is any impact of therapy in the dermatology quality of life index
Evaluate the histopathologic changes of YAG therapy on affected skin
Second phase of study
Prospective controlled clinical and histologic study of patients with Hurley Stage II HS disease
19 patients of skin types II to VI with Hurley Stage II hidradenitis suppurativa lesions of the axilla and groin This is a different set of patients than those treated in the first phase of the study above This study primarily focuses on and further characterizes the histologic changes after laser treatment
Determination of patient tolerance of discomfort associated with NdYag laser treatment for Hidradenitis suppurativa
Determination of the impact of this condition on quality of life and if there is any impact of therapy in the dermatology quality of life index
Evaluate the histopathologic changes of YAG therapy on affected skin
Second phase of study
Prospective controlled clinical and histologic study of patients with Hurley Stage II HS disease
19 patients of skin types II to VI with Hurley Stage II hidradenitis suppurativa lesions of the axilla and groin This is a different set of patients than those treated in the first phase of the study above This study primarily focuses on and further characterizes the histologic changes after laser treatment
Detailed Description:
1 Background
Hidradenitis suppurativa HS is a chronic suppurative recurrent disease of the apocrine glands Histological studies suggest that it is a disease of the follicles with apocrine involvement as a secondary event There is limited efficacy of medical treatments and high morbidity for surgical treatment Limited data are available on the short and long term efficacy of laser treatments for use in HS
2 Purpose of the study
To investigate the efficacy of NdYag 1064nm laser for the treatment of hidradenitis suppurativa
3 Significance
Hidradenitis suppurativa is a chronic often suppurative skin condition which affects primarily the hair follicles A variety of therapies have been used to treat HS often with unsatisfactory results As the Nd Yag laser is a highly effective laser treatment for hair removal as well as for the treatment of deeper follicular disorders of the skin which associated inflammation we postulate that the Nd Yag may be highly effective for decreasing the inflammation pain suppuration and frequency of recurrence of HS
4 Study design
we are treating patients with HS Hurley Stage II on one side of the body with long-pulsed NdYAG laser
The control is the patients opposite symmetrical side of the body
Pre-treatment assessment is performed along the Hidradenitis Suppurativa European Research Group HISERG scale
The control will be the patients opposite symmetrical side of the body
Each patient is treated on a monthly basis for up to 4 months and then 2 months of follow up to observe the long term effect of the treatment and to detect any relapse
A study of our primary investigator on treating dissecting cellulitis which is also a follicular disease like HS with the long-pulsed NdYAG laser aimed at determination of the capabilities and limitations of this modality with respect to reducing pus formation enabling the termination of systemic treatments investigating the side-effect profile including dyspigmentation and scarring alopecia and terminating the disease process The study showed that one year after initiating laser treatment patients achieved decreased pus formation a reduced reliance on systemic treatments and a controlled or terminated disease process without dyspigmentation
5 Second phase of study
Two monthly laser sessions were performed using the long-pulsed NdYAG 1064 nm laser on a new set of 19 patients
Clinical response was scored using the modified Hidradenitis Suppurativa Lesion Area and Severity Index LASI Histologic changes were examined before treatment 1 week 1 month and 2 months post-treatment Histologic controls were obtained from untreated involved sites
Hidradenitis suppurativa HS is a chronic suppurative recurrent disease of the apocrine glands Histological studies suggest that it is a disease of the follicles with apocrine involvement as a secondary event There is limited efficacy of medical treatments and high morbidity for surgical treatment Limited data are available on the short and long term efficacy of laser treatments for use in HS
2 Purpose of the study
To investigate the efficacy of NdYag 1064nm laser for the treatment of hidradenitis suppurativa
3 Significance
Hidradenitis suppurativa is a chronic often suppurative skin condition which affects primarily the hair follicles A variety of therapies have been used to treat HS often with unsatisfactory results As the Nd Yag laser is a highly effective laser treatment for hair removal as well as for the treatment of deeper follicular disorders of the skin which associated inflammation we postulate that the Nd Yag may be highly effective for decreasing the inflammation pain suppuration and frequency of recurrence of HS
4 Study design
we are treating patients with HS Hurley Stage II on one side of the body with long-pulsed NdYAG laser
The control is the patients opposite symmetrical side of the body
Pre-treatment assessment is performed along the Hidradenitis Suppurativa European Research Group HISERG scale
The control will be the patients opposite symmetrical side of the body
Each patient is treated on a monthly basis for up to 4 months and then 2 months of follow up to observe the long term effect of the treatment and to detect any relapse
A study of our primary investigator on treating dissecting cellulitis which is also a follicular disease like HS with the long-pulsed NdYAG laser aimed at determination of the capabilities and limitations of this modality with respect to reducing pus formation enabling the termination of systemic treatments investigating the side-effect profile including dyspigmentation and scarring alopecia and terminating the disease process The study showed that one year after initiating laser treatment patients achieved decreased pus formation a reduced reliance on systemic treatments and a controlled or terminated disease process without dyspigmentation
5 Second phase of study
Two monthly laser sessions were performed using the long-pulsed NdYAG 1064 nm laser on a new set of 19 patients
Clinical response was scored using the modified Hidradenitis Suppurativa Lesion Area and Severity Index LASI Histologic changes were examined before treatment 1 week 1 month and 2 months post-treatment Histologic controls were obtained from untreated involved sites
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