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CompletedNCT00494351Updated Apr 30, 2024

Study on the Effect of NdYag Laser for the Treatment of Hidradenitis Suppurativa

An interventional study of Long-pulsed Nd:YAG laser 1064 nm in Hidradenitis Suppurativa, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by Henry Ford Health System · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Hidradenitis Suppurativa

Keywords

  • Hidradenitis Suppurativa
  • Nd:YAG laser
03

In context

Hidradenitis Suppurativa

280 studies on the registry are indexed under Hidradenitis Suppurativa; 85 are open to participants now.

This study's enrollment of 20 is below the median of 44 across 196 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 24 (65%) have results posted.

Browse Henry Ford Health System studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
20 participants (actual)

Interventions

  • ProcedureLong-pulsed Nd:YAG laser 1064 nm

    Laser once monthly

    Also known as: Long pulsed Nd:YAG laser

06

What researchers measure

Primary outcomes

  1. We will be measuring patients' response by the clinical scoring criteria of the Hidradenitis Suppurativa European Research Group (HISERG) scale.

    Time frame: 6 months

  2. Examining histologic changes at various time points following 1064 nm Nd:YAG laser treatment of hidradenitis suppurativa.

    Time frame: 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.

    Time frame: Monthly, through 6 months

07

Study locations

1 site
  • Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
    Detroit, Michigan 48202, United States
08

References and documents

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 16918566 ↗
  • Mahmoud 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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2007, a primary completion of May 2009 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2007
First posted
Jun 29, 2007
Start
Jun 2007
Primary completionActual
May 2009
CompletionActual
Jul 2009
Last update
Apr 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00494351
Lead sponsor
Henry Ford Health System
Responsible party
Iltefat Hamzavi (Dermatologist, Henry Ford Health System) — Principal investigator
First posted
Jun 29, 2007
Start date
Jun 2007
Primary completion
May 2009
Completion
Jul 2009
Last update
Apr 30, 2024

Study contacts

Iltefat H. Hamzavi, M.D.
principal investigator · Department of Dermatology, Henry Ford Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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