Hidradenitis SuppurativaNCT03054155
Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser
A study testing Alexandrite Laser in people with Hidradenitis Suppurativa, run by Wayne State University at 1 site in United States.
Trial summary
Patients with bilateral hidradenitis in the axilla, groin and/or inframammary will be treated on one side with the Alexandrite hair removal laser. The other side will serve as the control. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Alexandrite Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2017to 31 Oct 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
- Patients with Hidradenitis Suppurativa with bilateral and symmetric disease with one or more anatomic sites of involvement.
Who cannot join
- Pregnant patients or patients planning to get pregnant during the time of the study
- Patients on systemic treatment for Hidradenitis Suppurativa
- Patients with photosensitivity disorders
- Patients unable to tolerate the laser treatments
- Intake of a photosensitive medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University Physician Group Dermatology
Dearborn, Michigan, 48124
About this study
Patients with bilateral hidradenitis in the axilla, groin and/or inframammary will be treated on one side with the Alexandrite hair removal laser. The other side will serve as the control.
Read the detailed description
Patients with bilateral disease will be chosen to participate in the study. Patients will be advised to discontinue any prior systemic HS treatments two weeks before their first laser session as a wash out period. One side of the patient will be chosen as the treatment side, the other as an intrinsic control. Each participant will have a total of 4 treatments with the laser, one treatment per month over the duration of 4 months. Patients will then participate in a follow-up clinic visit two months after completion of their last treatment. In between laser sessions, participants will be allowed to use benzoyl peroxide 10% wash as a skin cleanser and clindamycin 1% solution or lotion as a topical therapy, both twice daily to the treatment and control areas. At each visit, photographs will be taken of the lesions to monitor progression and to serve as a comparison to the control side. The treatment side will be treated with the laser and adjusted according to skin type as follows:
Skin type I-II (Fair Caucasian): Fluence: 30J/cm2 Skin type III (Darker Caucasian, light Asian): Fluence: 25 J/cm2 Skin type IV (Mediterranean, Asian, Latin): Fluence: 18 J/cm2 Skin type V (Light skinned black, Darker mediterranean): Fluence: 16J/cm2 Skin type VI (Dark skinned black): Fluence 14 J/cm2
A spot size of 12 mm and a cryogen spray delay of 50/50 will be used for all treated patients. The treatment area will not exceed 15cm x 15cm. If the patient cannot tolerate treatment with the Alexandrite laser, the patient will be terminated from the study. Following each treatment session, the patient will be given an ice pack to reduce any discomfort the patient may experience as a result of treatment with the laser. Clinical evaluation and photographs will determine improvement.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Alexandrite Laser
- Keywords
- hidradenitis suppurativa, hidradenitis, laser
- Medical subject headings
- Hidradenitis Suppurativa, Hidradenitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alexandrite LaserDevice
Alexandrite 755nm hair removal laser
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | For each patient, one side of the body will be treated with the Alexandrite laser (the treatment arm) and the other will not be treated to serve as control (the control arm). For example, if a patient has the disease in both axillae, one will treatment and the other control Receives: Device: Alexandrite Laser |
| Control Arm | No intervention | For each patient, one side of the body will be treated with the Alexandrite laser (the treatment arm) and the other will not be treated to serve as control (the control arm). For example, if a patient has the disease in both axillae, one will treatment and the other control |
What is being measured
The primary outcome is the main question the study is designed to answer.
HS-LASI
Change in Hidradenitis Suppurativa Lesion, Area, and Severity Index Score from baseline
Measured: Monthly for 4 months, then once 2 months later(6 months total)
Secondary outcomes (1)
HiSCR
Change in Hidradenitis Suppurativa Clinical Response Scale from baseline
Measured: Monthly for 4 months, then once 2 months later(6 months total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start11 May 2017
- Primary completion1 Sep 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- For each patient, one side of the body will serve as the treatment side and the other side as the control
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven D Daveluy, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054155
- Sponsor's protocol ID
- 120116M1F
- Status last verified
- May 2023
- First submitted
- 9 Feb 2017
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 19438670Mahmoud 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 20227579Kimball AB, Sobell JM, Zouboulis CC, Gu Y, Williams DA, Sundaram M, Teixeira HD, Jemec GB. HiSCR (Hidradenitis Suppurativa Clinical Response): a novel clinical endpoint to evaluate therapeutic outcomes in patients with hidradenitis suppurativa from the placebo-controlled portion of a phase 2 adalimumab study. J Eur Acad Dermatol Venereol. 2016 Jun;30(6):989-94. doi: 10.1111/jdv.13216. Epub 2015 Jul 22.
PubMed 26201313
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser
- ClinicalTrials.gov ID
- NCT03054155
- Acronym / sponsor ID
- 120116M1F
- Conditions
- Hidradenitis Suppurativa
- Keywords
- hidradenitis suppurativa, hidradenitis, laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 15 Feb 2017 (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.
Patients with bilateral hidradenitis in the axilla, groin and/or inframammary will be treated on one side with the Alexandrite hair removal laser. The other side will serve as the control.
Detailed description
Patients with bilateral disease will be chosen to participate in the study. Patients will be advised to discontinue any prior systemic HS treatments two weeks before their first laser session as a wash out period. One side of the patient will be chosen as the treatment side, the other as an intrinsic control. Each participant will have a total of 4 treatments with the laser, one treatment per month over the duration of 4 months. Patients will then participate in a follow-up clinic visit two months after completion of their last treatment. In between laser sessions, participants will be allowed to use benzoyl peroxide 10% wash as a skin cleanser and clindamycin 1% solution or lotion as a topical therapy, both twice daily to the treatment and control areas. At each visit, photographs will be taken of the lesions to monitor progression and to serve as a comparison to the control side. The treatment side will be treated with the laser and adjusted according to skin type as follows:
Skin type I-II (Fair Caucasian): Fluence: 30J/cm2 Skin type III (Darker Caucasian, light Asian): Fluence: 25 J/cm2 Skin type IV (Mediterranean, Asian, Latin): Fluence: 18 J/cm2 Skin type V (Light skinned black, Darker mediterranean): Fluence: 16J/cm2 Skin type VI (Dark skinned black): Fluence 14 J/cm2
A spot size of 12 mm and a cryogen spray delay of 50/50 will be used for all treated patients. The treatment area will not exceed 15cm x 15cm. If the patient cannot tolerate treatment with the Alexandrite laser, the patient will be terminated from the study. Following each treatment session, the patient will be given an ice pack to reduce any discomfort the patient may experience as a result of treatment with the laser. Clinical evaluation and photographs will determine improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For each patient, one side of the body will serve as the treatment side and the other side as the control
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Alexandrite LaserFor each patient, one side of the body will be treated with the Alexandrite laser (the treatment arm) and the other will not be treated to serve as control (the control arm). For example, if a patient has the disease in both axillae, one will treatment and the other control |
| Control Arm | No intervention | –For each patient, one side of the body will be treated with the Alexandrite laser (the treatment arm) and the other will not be treated to serve as control (the control arm). For example, if a patient has the disease in both axillae, one will treatment and the other control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65
- Patients with Hidradenitis Suppurativa with bilateral and symmetric disease with one or more anatomic sites of involvement.
Key exclusion criteria (5 listed)
- Pregnant patients or patients planning to get pregnant during the time of the study
- Patients on systemic treatment for Hidradenitis Suppurativa
- Patients with photosensitivity disorders
- Patients unable to tolerate the laser treatments
- Intake of a photosensitive medication
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 |
|---|---|---|
| Alexandrite LaserAlexandrite 755nm hair removal laser | Device | Treatment Arm |
Primary outcome
HS-LASI
Time frame: Monthly for 4 months, then once 2 months later(6 months total)
Change in Hidradenitis Suppurativa Lesion, Area, and Severity Index Score from baseline
1 secondary outcome
HiSCR
Time frame: Monthly for 4 months, then once 2 months later(6 months total)
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 16 May 2023.
- 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 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.
- Background: PubMed 26201313Kimball AB, Sobell JM, Zouboulis CC, Gu Y, Williams DA, Sundaram M, Teixeira HD, Jemec GB. HiSCR (Hidradenitis Suppurativa Clinical Response): a novel clinical endpoint to evaluate therapeutic outcomes in patients with hidradenitis suppurativa from the placebo-controlled portion of a phase 2 adalimumab study. J Eur Acad Dermatol Venereol. 2016 Jun;30(6):989-94. doi: 10.1111/jdv.13216. Epub 2015 Jul 22.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alexandrite Laser in people with Hidradenitis Suppurativa, run by Wayne State University 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 2 inclusion and 5 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 16 May 2023. 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?
HS-LASI (time frame: Monthly for 4 months, then once 2 months later(6 months total)). 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 NCT03054155, which also lists 3 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 16 May 2023.