Hidradenitis SuppurativaNCT05927948
Evaluating the Safety and Efficacy of Laight®-Therapy Treatment in Subjects With Hidradenitis Suppurativa
A study testing Laight therapy, NICE V3.1 device in people with Hidradenitis Suppurativa, run by Henry Ford Health System at 1 site in United States.
Trial summary
Hidradenitis suppurativa (HS) is a debilitating and chronic condition characterized by recurrent episodes of inflammation associated with the formation of abscesses, inflammatory nodules, pain, and drainage ultimately culminating in the formation of scarring in moderate to severe disease. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Laight therapy, NICE V3.1 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 1 Dec 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years old.
- Have a diagnosis of Hurley stage I or II HS.
- Patients must have bilateral HS in the axilla, groin, or breast.
- Hurley stage 1 or 2 disease in either the axillae, groin, or inframammary locations.
- At least 2 clinically observable lesions in the axilla, groin or breast.
- 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
- No diagnosis of HS in the axillae or groin.
- Tattoos located on proposed treatment locations.
- Metal implants of intended treatment areas.
- History of acne conglobata.
- Concomitant use of antibiotics in the tetracycline class or oral or topical retinoids (permitted with 14-day washout period).
- Concomitant use of biologic medications (6-month washout period).
Show all 10Show fewer
- Concomitant use of other topical treatments of HS in intended treatment locations (14-day washout period), except for topical benzoyl peroxide or topical clindamycin gel or lotion.
- History of melanoma.
- Active skin cancer in the proposed treatment area (non-melanoma in the past 6 month).
- Current Nd:YAG laser hair removal for HS treatment in the study area.
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Hospital Systems- New Center One
Detroit, Michigan, 48202
About this study
Hidradenitis suppurativa (HS) is a debilitating and chronic condition characterized by recurrent episodes of inflammation associated with the formation of abscesses, inflammatory nodules, pain, and drainage ultimately culminating in the formation of scarring in moderate to severe disease. HS affects more women than men in a ratio of approximately 3:1, and onset of the disease is typically after puberty. The axillae, breasts, groin, buttocks, and lower abdomen are common intertriginous regions which are affected by HS, and significant impacts on quality of life are reported in the literature.
The Hurley Staging system is commonly utilized to classify the severity of a patient\'s hidradenitis suppurativa. Stage 1 disease consists of one or more abscesses with no sinus tract formation or scarring. Stage 2 disease involves one or more widely separated recurrent abscesses, with formation of a sinus tract and/or scarring. Stage 3 involves multiple interconnected sinus tracts and/or abscesses throughout an anatomical area.
Read more
Histologic studies of HS suggest that follicular hyperkeratosis and obstruction is the primary event in the pathogenesis. Subsequently, there is rupture of the follicular infundibulum and a resulting inflammatory cascade. Despite recurrent episodes of purulent drainage, bacteria do not appear to play a primary role in the pathogenesis.
The traditional repertoire of treatment options for HS can be divided into medical and surgical options, however there is currently no cure for HS and treatments focus on symptomatic control. Medical treatments including topical and systemic antibiotics, hormonal agents, and biologic medications can successfully control symptoms however discontinuation of many of these is associated with relapses in disease symptoms. Conversely, surgical interventions such as traditional surgical excision performed in an operating room, or carbon dioxide laser excision performed under local anesthetic in an outpatient setting can induce long term symptom control however may not be appropriate for all patients considering the risk of general anesthesia, high cost of inpatient hospitalizations, and cumbersome healing process for procedures which heal by secondary intention. Despite numerous treatment options for HS, efficacious and non-invasive treatment options which result in long term remission of disease are needed to meet the needs of HS patients.
Read the detailed description
Subjects receive treatment every 2 weeks for a total of 22 weeks, 10 treatments. Subject treatment side will be randomized via computer generated assignments.
Ultrasound imaging will be utilized to assess abscesses, nodules, and sinus tracts at investigator discretion. Patient-reported outcome measures include DLQI and Pain VAS. Physician-reported outcome measures include: HS-PGA, IHS4, Hurley Staging, and HiSCR.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Laight therapy, NICE V3.1 device
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laight therapy, NICE V3.1 deviceDevice
Laight therapy is a non-invasive method of treatment for HS and acne developed in Germany which utilizes a combination of radiofrequency and intense pulsed light exposure. Three passes of the device, all coupled with radiofrequency, are used in the proposed treatment area. The first pass encompasses wavelengths between 420 nm and 1200 nm, the second between 510 nm and 1200 nm, and the third pass between 690 nm and 1200 nm.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This is a split body study. The patients will serve as their own control. The side that receives Laight therapy will be randomized. For example, if the patient receives Laight therapy on the right, then the control will be the left. Receives: Device: Laight therapy, NICE V3.1 device |
| Control | No intervention | This is a split body study. The patients will serve as their own control. The control side of the body will be randomized. For example, if the patient receives Laight therapy on the right, then the control will be the left. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hurley Stage
Classification of HS severity Participant treatment location will be assessed using the Hurley Staging scale Stage I (Mild) Inflammatory nodule or abscess formation, single or multiple, without sinus tracts and scarring Stage II (Moderate) Recurrent abscesses and nodules with sinus tract formation or scarring: single or multiple widely separated lesions Stage III (Severe) Diffuse or near-diffuse involvement with multiple interconnected sinus tracts, scarring, and abscesses across entire area
Measured: 22 weeks
Secondary outcomes (5)
Hidradenitis Suppurativa Clinical Response Score
Severity and activity of hidradenitis suppurativa assessment with a target of reaching a 50% reduction in the AN (abscess nodule) count
HiSCR:
- Abscesses: fluctuant, with or without drainage, tender or painful
- Inflammatory nodules: tender, erythematous, pyogenic granuloma lesion
- Draining fistulas: sinus tracts, with communications to skin surface, draining purulent fluid
- Definition
- AN (abcess nodule) Count= Abscess and inflammatory nodule count
- At least a 50% reduction in AN count
- No increase in the number of abscesses
- No increase in the number of draining fistulas from baseline
Measured: baseline and end of treatment (22 weeks)
Dermatology Life Quality Index
patient reported outcome measure of quality of life assessment
DLQI Scoring SCORING
The scoring of each question is as follows:
Very much, scored 3 A lot scored, 2 A little scored, 1 Not at all scored, 0 Not relevant scored, 0 Question 7, 'prevented work or studying', scored 3 The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
DLQI SCORE INTERPRETATION 0 - 1 no effect at all on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life
Measured: baseline and end of treatment (22 weeks)
Hidradenitis suppurativa physician global assessment
physician global assessment of HS severity
HS PGA Clear 0 abscesses, 0 draining fistulas, 0 inflammatory nodules, and 0 noninflammatory nodules
Minimal 0 abscesses, 0 draining fistulas, 0 inflammatory nodules, and presence of noninflammatory nodules
Mild 0 abscesses, 0 draining fistulas, 1-4 inflammatory nodules Or 1 abscess or draining fistula and inflammatory nodules
Moderate 0 abscesses, 0 draining fistulas, and ≥ 5 inflammatory nodules Or 1 abscess or draining fistula and ≥ 1 inflammatory nodule Or 2-5 abscesses or draining fistulas and < 10 inflammatory nodules
Severe 2-5 abscesses or draining fistulas and ≥ 10 inflammatory nodules Very Severe >5 abscesses or draining fistulas
Measured: baseline and end of treatment (22 weeks)
International HS Severity Scoring
severity scoring
IHS4 (points)= Number of nodules x 1 + Number of abscesses x 2 + Number of draining tunnels (fistulae/sinuses) x 4
A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease.
Measured: baseline and end of treatment (22 weeks)
Pain Visual Analog Scale
Scale of 1-10, 1 being the least amount of pain, 10 being the most amount of pain
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start4 Nov 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2021
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The patient has one side exposed to treatment and the other side receives no treatment as the comparison. Hence, patient serves as their own control.
- Masking
- None (open label)
- Enrolment
- 10 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 Hamzavi, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927948
- Sponsor's protocol ID
- IRB11922
- Status last verified
- Oct 2024
- First submitted
- 26 Mar 2019
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tierney E, Mahmoud BH, Hexsel C, Ozog D, Hamzavi I. Randomized control trial for the treatment of hidradenitis suppurativa with a neodymium-doped yttrium aluminium garnet laser. Dermatol Surg. 2009 Aug;35(8):1188-98. doi: 10.1111/j.1524-4725.2009.01214.x. Epub 2009 May 12.
PubMed 19438670Wilden S, Friis M, Tuettenberg A, Staubach-Renz P, Wegner J, Grabbe S, von Stebut E. Combined treatment of hidradenitis suppurativa with intense pulsed light (IPL) and radiofrequency (RF). J Dermatolog Treat. 2021 Aug;32(5):530-537. doi: 10.1080/09546634.2019.1677842. Epub 2019 Oct 17.
PubMed 31609667
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Efficacy of Laight®-Therapy Treatment in Subjects With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT05927948
- Acronym / sponsor ID
- IRB11922
- Conditions
- Hidradenitis Suppurativa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 Jul 2023 (actual)
- 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.
Hidradenitis suppurativa (HS) is a debilitating and chronic condition characterized by recurrent episodes of inflammation associated with the formation of abscesses, inflammatory nodules, pain, and drainage ultimately culminating in the formation of scarring in moderate to severe disease. HS affects more women than men in a ratio of approximately 3:1, and onset of the disease is typically after puberty. The axillae, breasts, groin, buttocks, and lower abdomen are common intertriginous regions which are affected by HS, and significant impacts on quality of life are reported in the literature.
The Hurley Staging system is commonly utilized to classify the severity of a patient\'s hidradenitis suppurativa. Stage 1 disease consists of one or more abscesses with no sinus tract formation or scarring. Stage 2 disease involves one or more widely separated recurrent abscesses, with formation of a sinus tract and/or scarring. Stage 3 involves multiple interconnected sinus tracts and/or abscesses throughout an anatomical area.
Histologic studies of HS suggest that follicular hyperkeratosis and obstruction is the primary event in the pathogenesis. Subsequently, there is rupture of the follicular infundibulum and a resulting inflammatory cascade. Despite recurrent episodes of purulent drainage, bacteria do not appear to play a primary role in the pathogenesis.
The traditional repertoire of treatment options for HS can be divided into medical and surgical options, however there is currently no cure for HS and treatments focus on symptomatic control. Medical treatments including topical and systemic antibiotics, hormonal agents, and biologic medications can successfully control symptoms however discontinuation of many of these is associated with relapses in disease symptoms. Conversely, surgical interventions such as traditional surgical excision performed in an operating room, or carbon dioxide laser excision performed under local anesthetic in an outpatient setting can induce long term symptom control however may not be appropriate for all patients considering the risk of general anesthesia, high cost of inpatient hospitalizations, and cumbersome healing process for procedures which heal by secondary intention. Despite numerous treatment options for HS, efficacious and non-invasive treatment options which result in long term remission of disease are needed to meet the needs of HS patients.
Detailed description
Subjects receive treatment every 2 weeks for a total of 22 weeks, 10 treatments. Subject treatment side will be randomized via computer generated assignments.
Ultrasound imaging will be utilized to assess abscesses, nodules, and sinus tracts at investigator discretion. Patient-reported outcome measures include DLQI and Pain VAS. Physician-reported outcome measures include: HS-PGA, IHS4, Hurley Staging, and HiSCR.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patient has one side exposed to treatment and the other side receives no treatment as the comparison. Hence, patient serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Laight therapy, NICE V3.1 deviceThis is a split body study. The patients will serve as their own control. The side that receives Laight therapy will be randomized. For example, if the patient receives Laight therapy on the right, then the control will be the left. |
| Control | No intervention | –This is a split body study. The patients will serve as their own control. The control side of the body will be randomized. For example, if the patient receives Laight therapy on the right, then the control will be the left. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be at least 18 years old.
- Have a diagnosis of Hurley stage I or II HS.
- Patients must have bilateral HS in the axilla, groin, or breast.
- Hurley stage 1 or 2 disease in either the axillae, groin, or inframammary locations.
- At least 2 clinically observable lesions in the axilla, groin or breast.
Key exclusion criteria (10 listed)
- No diagnosis of HS in the axillae or groin.
- Tattoos located on proposed treatment locations.
- Metal implants of intended treatment areas.
- History of acne conglobata.
- Concomitant use of antibiotics in the tetracycline class or oral or topical retinoids (permitted with 14-day washout period).
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 |
|---|---|---|
| Laight therapy, NICE V3.1 deviceLaight therapy is a non-invasive method of treatment for HS and acne developed in Germany which utilizes a combination of radiofrequency and intense pulsed light exposure. Three passes of the device, all coupled with radiofrequency, are used in the proposed treatment area. The first pass encompasses wavelengths between 420 nm and 1200 nm, the second between 510 nm and 1200 nm, and the third pass between 690 nm and 1200 nm. | Device | Intervention |
Primary outcome
Hurley Stage
Time frame: 22 weeks
Classification of HS severity Participant treatment location will be assessed using the Hurley Staging scale Stage I (Mild) Inflammatory nodule or abscess formation, single or multiple, without sinus tracts and scarring Stage II (Moderate) Recurrent abscesses and nodules with sinus tract formation or scarring: single or multiple widely separated lesions Stage III (Severe) Diffuse or near-diffuse involvement with multiple interconnected sinus tracts, scarring, and abscesses across entire area
5 secondary outcomes
Hidradenitis Suppurativa Clinical Response Score
Time frame: baseline and end of treatment (22 weeks)
Dermatology Life Quality Index
Time frame: baseline and end of treatment (22 weeks)
Hidradenitis suppurativa physician global assessment
Time frame: baseline and end of treatment (22 weeks)
International HS Severity Scoring
Time frame: baseline and end of treatment (22 weeks)
Pain Visual Analog Scale
Time frame: 22 weeks
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 9 Oct 2024.
- Background: PubMed 19438670Tierney E, Mahmoud BH, Hexsel C, Ozog D, Hamzavi I. Randomized control trial for the treatment of hidradenitis suppurativa with a neodymium-doped yttrium aluminium garnet laser. Dermatol Surg. 2009 Aug;35(8):1188-98. doi: 10.1111/j.1524-4725.2009.01214.x. Epub 2009 May 12.
- Background: PubMed 31609667Wilden S, Friis M, Tuettenberg A, Staubach-Renz P, Wegner J, Grabbe S, von Stebut E. Combined treatment of hidradenitis suppurativa with intense pulsed light (IPL) and radiofrequency (RF). J Dermatolog Treat. 2021 Aug;32(5):530-537. doi: 10.1080/09546634.2019.1677842. Epub 2019 Oct 17.
- Individual participant dataSharing planned: No
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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 Hamzavi principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laight therapy, NICE V3.1 device 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 7 inclusion and 10 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 9 Oct 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?
Hurley Stage (time frame: 22 weeks). 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 NCT05927948, 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 9 Oct 2024.