Hidradenitis SuppurativaNCT00494351
Study on the Effect of NdYag Laser for the Treatment of Hidradenitis Suppurativa
A study testing Long-pulsed Nd:YAG laser 1064 nm in people with Hidradenitis Suppurativa, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Long-pulsed Nd:YAG laser 1064 nm
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion, the subject must:
- Be at least 18 years old
- Be otherwise healthy
- Have a diagnosis of HS
- Patients with Hurley stage II, with one ore more widely separated recurrent abscesses, with a tract and scarring, bilateral and symmetrical, will be eligible for inclusion in the study.
- Agree to abide by the Investigator's guidelines regarding photosensitizing drugs
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
- Agree to follow and undergo all study-related procedures.
Who cannot join
- Patients with Hidradenitis Hurley state I and III will be excluded from participation in the study.
- The control for this study will be the patient's opposite side of the body, i.e., for patients treated on the left axilla, the right axilla will serve as the corresponding control.
- Concomitant use of systemic or topical treatments for HS. Patients must discontinue all forms of oral therapy as systemic and topical antibiotics and retinoids for 2 weeks prior to the start of any treatment.
- Exacerbation of the patient's original condition expressed clinically by a shift from Hurley Stage II to Stage III.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
Detroit, Michigan, 48202
About this study
Official title: Prospective Controlled Study of the Efficacy of NdYag for Hidradenitis Suppurativa
- 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.
Read the detailed description
- 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.
- Purpose of the study: To investigate the efficacy of NdYag 1064nm laser for the treatment of hidradenitis suppurativa.
- 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.
- 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.
- 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Long-pulsed Nd:YAG laser 1064 nm
- Keywords
- Hidradenitis Suppurativa, Nd:YAG laser
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-pulsed Nd:YAG laser 1064 nmProcedure or surgery
Also called Long pulsed Nd:YAG laser
Laser once monthly
What is being measured
The primary outcome is the main question the study is designed to answer.
We will be measuring patients' response by the clinical scoring criteria of the Hidradenitis Suppurativa European Research Group (HISERG) scale.
Measured: 6 months
Examining histologic changes at various time points following 1064 nm Nd:YAG laser treatment of hidradenitis suppurativa.
Measured: 6 months.
Secondary outcomes (1)
Completion of a post treatment survey regarding the pain of the treatment, pain of their skin condition after treatment, frequency of breakouts, effectiveness of treatment, overall level of satisfaction, likelihood to use the treatment again.
Measured: Monthly, through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
- Investigators
- Iltefat H. Hamzavi, M.D., Principal investigator, Department of Dermatology, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494351
- Sponsor's protocol ID
- IRB4309
- Status last verified
- Apr 2024
- First submitted
- 27 Jun 2007
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Krasner BD, Hamzavi FH, Murakawa GJ, Hamzavi IH. Dissecting cellulitis treated with the long-pulsed Nd:YAG laser. Dermatol Surg. 2006 Aug;32(8):1039-44. doi: 10.1111/j.1524-4725.2006.32227.x.
PubMed 16918566Mahmoud BH, Tierney E, Hexsel CL, Pui J, Ozog DM, Hamzavi IH. Prospective controlled clinical and histopathologic study of hidradenitis suppurativa treated with the long-pulsed neodymium:yttrium-aluminium-garnet laser. J Am Acad Dermatol. 2010 Apr;62(4):637-45. doi: 10.1016/j.jaad.2009.07.048.
PubMed 20227579
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Study of the Efficacy of NdYag for Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT00494351
- Acronym / sponsor ID
- IRB4309
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, Nd:YAG laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed description
- 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.
- Purpose of the study: To investigate the efficacy of NdYag 1064nm laser for the treatment of hidradenitis suppurativa.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be at least 18 years old
- Be otherwise healthy
- Have a diagnosis of HS
- Patients with Hurley stage II, with one ore more widely separated recurrent abscesses, with a tract and scarring, bilateral and symmetrical, will be eligible for inclusion in the study.
- Agree to abide by the Investigator's guidelines regarding photosensitizing drugs
Key exclusion criteria (4 listed)
- Patients with Hidradenitis Hurley state I and III will be excluded from participation in the study.
- The control for this study will be the patient's opposite side of the body, i.e., for patients treated on the left axilla, the right axilla will serve as the corresponding control.
- Concomitant use of systemic or topical treatments for HS. Patients must discontinue all forms of oral therapy as systemic and topical antibiotics and retinoids for 2 weeks prior to the start of any treatment.
- Exacerbation of the patient's original condition expressed clinically by a shift from Hurley Stage II to Stage III.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-pulsed Nd:YAG laser 1064 nmAlso: Long pulsed Nd:YAG laserLaser once monthly | Procedure or surgery | – |
Primary outcome
We will be measuring patients' response by the clinical scoring criteria of the Hidradenitis Suppurativa European Research Group (HISERG) scale.
Time frame: 6 months
Examining histologic changes at various time points following 1064 nm Nd:YAG laser treatment of hidradenitis suppurativa.
Time frame: 6 months.
1 secondary outcome
Completion of a post treatment survey regarding the pain of the treatment, pain of their skin condition after treatment, frequency of breakouts, effectiveness of treatment, overall level of satisfaction, likelihood to use the treatment again.
Time frame: Monthly, through 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Results publication: PubMed 16918566Krasner BD, Hamzavi FH, Murakawa GJ, Hamzavi IH. Dissecting cellulitis treated with the long-pulsed Nd:YAG laser. Dermatol Surg. 2006 Aug;32(8):1039-44. doi: 10.1111/j.1524-4725.2006.32227.x.
- Derived from this study: PubMed 20227579Mahmoud BH, Tierney E, Hexsel CL, Pui J, Ozog DM, Hamzavi IH. Prospective controlled clinical and histopathologic study of hidradenitis suppurativa treated with the long-pulsed neodymium:yttrium-aluminium-garnet laser. J Am Acad Dermatol. 2010 Apr;62(4):637-45. doi: 10.1016/j.jaad.2009.07.048.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iltefat H. Hamzavi, M.D. principal investigator
Department of Dermatology, Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-pulsed Nd:YAG laser 1064 nm in people with Hidradenitis Suppurativa, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
We will be measuring patients' response by the clinical scoring criteria of the Hidradenitis Suppurativa European Research Group (HISERG) scale. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00494351, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.