Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT00494351
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2007-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Effect of NdYag Laser for the Treatment of Hidradenitis Suppurativa
Sponsor:
Henry Ford Health System
Organization:
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 Nd:YAG laser.
* The control is the patient's 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 patient's 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 Nd:YAG 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 Nd:YAG 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 Nd:YAG laser.
* The control is the patient's 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 patient's 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 Nd:YAG 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 Nd:YAG 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:
False
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?: