Hidradenitis SuppurativaPhase 3NCT00367328
To Determine the Efficacy of a Laser Device for the Treatment of Hidradenitis Suppurativa
A Phase 3 study testing 1320nm Nd: YAG nonablative laser in people with Hidradenitis Suppurativa, run by University of California, Davis at 1 site in United States.
Trial summary
A research study to determine the efficacy of a 1320 nm laser device for the treatment of hidradenitis suppurativa. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- 1320nm Nd: YAG nonablative laser
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Apr 2006
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age equal to or greater than 18 years
- General good health and willingness to participate and ability to comply with the study protocol
- Biopsy proven hidradenitis suppurativa
Who cannot join
- Age < 18 years
- Pregnancy
- Hx of collagen vascular or photosensitive disorders
- Inability to follow-up with treatments
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center Department of Dermatology
Sacramento, California, 95817
About this study
Official title: To Determine The Efficacy Of A 1320nm Nd: YAG Nonablative Laser For Treatment of Hidradenitis Suppurativa
A research study to determine the efficacy of a 1320 nm laser device for the treatment of hidradenitis suppurativa.
Read the detailed description
Hidradenitis Suppurativa is a chronic, scarring disease. The treatments available for this condition are not very effective and work only for some patients.
Recently, a 1320nm laser device has been approved by the FDA for the treatment of acne and facial rejuvenation. Given the positive results seen with the use of this laser in the treatment of acne it is reasonable to hypothesize that a similar effect may be seen with the treatment of Hidradenitis suppurativa.
The specific aim of the study is to determine the efficacy of this device for the treatment of hidradenitis suppurativa as it relates to the patient's established treatment.
The investigators are trying to determine the efficacy of a laser for the treatment of hidradenitis suppurativa.
Patients will:
- be examined and interviewed
- have photographs taken of the treatment site
- have a 4mm punch biopsy performed
- have wound culture swabs performed
- Conditions
- Hidradenitis Suppurativa
- Being tested
- 1320nm Nd: YAG nonablative laser
- Keywords
- Hidradenitis Supperativa
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1320nm Nd: YAG nonablative laserDevice
Also called laser treatment
a 4 mm piece of skin tissue (about the size of a pencil-head eraser) from the affected area. This procedure is called a punch biopsy and will be done to confirm your diagnosis. A culture swab similar to a Q-Tip will be used to wipe the affected areas during the first visit to determine any bacteria that may be present. A survey with questions will be given at the first visit, again after 3 months and at the last visit to measure the success of the treatment. Photographs will be taken prior to each treatment and one month following your last treatment. A laser, which is a very powerful light, will be used to treat half of the skin that is affected by your condition.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Oral Antibiotics in standard care vs. Laser treatment Receives: Device: 1320nm Nd: YAG nonablative laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
A successful treatment is expected to improve the quality of life significantly by causing remission of disease. The data obtained from this study will also allow the development of laser-based treatment protocols for hidradenitis suppurativa.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startApr 2005
- Primary completionApr 2006
- Study completionApr 2006
Why it stopped: Terminated: recruiting or enrolling participants has halted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- CoolTouch, Inc
- Responsible party
- Sponsor
- Investigators
- Daniel Eisen, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367328
- Sponsor's protocol ID
- 200513081-1
- Status last verified
- Apr 2015
- First submitted
- 19 Aug 2006
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine The Efficacy Of A 1320nm Nd: YAG Nonablative Laser For Treatment of Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT00367328
- Acronym / sponsor ID
- 200513081-1
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Supperativa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated: recruiting or enrolling participants has halted.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- CoolTouch, Inc
- Study start
- Apr 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 22 Aug 2006 (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.
A research study to determine the efficacy of a 1320 nm laser device for the treatment of hidradenitis suppurativa.
Detailed description
Hidradenitis Suppurativa is a chronic, scarring disease. The treatments available for this condition are not very effective and work only for some patients.
Recently, a 1320nm laser device has been approved by the FDA for the treatment of acne and facial rejuvenation. Given the positive results seen with the use of this laser in the treatment of acne it is reasonable to hypothesize that a similar effect may be seen with the treatment of Hidradenitis suppurativa.
The specific aim of the study is to determine the efficacy of this device for the treatment of hidradenitis suppurativa as it relates to the patient's established treatment.
The investigators are trying to determine the efficacy of a laser for the treatment of hidradenitis suppurativa.
Patients will:
- be examined and interviewed
- have photographs taken of the treatment site
- have a 4mm punch biopsy performed
- have wound culture swabs performed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: 1320nm Nd: YAG nonablative laserOral Antibiotics in standard care vs. Laser treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age equal to or greater than 18 years
- General good health and willingness to participate and ability to comply with the study protocol
- Biopsy proven hidradenitis suppurativa
Key exclusion criteria (4 listed)
- Age < 18 years
- Pregnancy
- Hx of collagen vascular or photosensitive disorders
- Inability to follow-up with treatments
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 |
|---|---|---|
| 1320nm Nd: YAG nonablative laserAlso: laser treatmenta 4 mm piece of skin tissue (about the size of a pencil-head eraser) from the affected area. This procedure is called a punch biopsy and will be done to confirm your diagnosis. A culture swab similar to a Q-Tip will be used to wipe the affected areas during the first visit to determine any bacteria that may be present. A survey with questions will be given at the first visit, again after 3 months and at the last visit to measure the success of the treatment. Photographs will be taken prior to each treatment and one month following your last treatment. A laser, which is a very powerful light, will be used to treat half of the skin that is affected by your condition. | Device | A |
Primary outcome
A successful treatment is expected to improve the quality of life significantly by causing remission of disease. The data obtained from this study will also allow the development of laser-based treatment protocols for hidradenitis suppurativa.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Terminated: recruiting or enrolling participants has halted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
Related trials for Hidradenitis Suppurativa
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
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Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
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ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
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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.
Daniel Eisen, M.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1320nm Nd: YAG nonablative laser in people with Hidradenitis Suppurativa, run by University of California, Davis 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 3 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: stopped early, as of the sponsor's last update on 7 Apr 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated: recruiting or enrolling participants has halted.). Results are not available in the source record.
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?
A successful treatment is expected to improve the quality of life significantly by causing remission of disease. The data obtained from this study will also allow the development of laser-based treatment protocols for hidradenitis suppurativa. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.