Hidradenitis SuppurativaNCT03203122
Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa
A study testing IPL laser in people with Hidradenitis Suppurativa and Acne Inversa, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
6 monthly treatments with IPL laser in patients with Hidradenitis Suppurativa. The effect in measured on several severity scores. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hidradenitis Suppurativa, Acne Inversa
- What is being tested?
- IPL laser
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Aug 2017to 1 Aug 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral HS in the axilla or groin area
- Fitzpatrick skin type I-II
Who cannot join
- Pregnant
- Unable to understand or communicate with study personnel
Trial locations and contacts
1 site in 1 country.
Gregor Jemec, DMSc contact
Denmark1 site, 1 recruiting
- Recruiting
University hospital Zealland
Roskilde, 4000
Peter T Riis, MD, 47322672, pmik@regionsjaelland.dk
Linnea Thorlacius, MD, 47322671, lrit@regionsjaelland.dk
About this study
Official title: The Effect of Intense Pulsed Light Assisted Hair Removal Therapy on Mild and Moderate Cases of Hidrosadenitis Suppurativa
6 monthly treatments with IPL laser in patients with Hidradenitis Suppurativa. The effect in measured on several severity scores.
Read the detailed description
Patient suffering from bilateral HS in the axilla or groin area are threated with IPL laser monthly for 6 months.
Patients are randomized to treatment in either left or right side, the other side works as control.
No sham treatment, but observers are blinded.
- Conditions
- Hidradenitis Suppurativa, Acne Inversa
- Being tested
- IPL laser, No sham treatment
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPL laserOther
IPL laser monthly. Vertical and horizontal treatment, one pass over. Settings according to fitzpatrick skin type
No sham treatmentOther
The treatment is slightly painful, and noisy. Sham treatment impossible
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients are randomized to treatment of either right or left side. The other side works as control Receives: Other: IPL laser |
| Comparator Group | Sham comparator | Patients are randomized to treatment in either right or left side. The other side works as control Receives: Other: No sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
HiScore
50 % reduction in abcesses and draining fistual
Measured: After 6 treatments i.e. 6 months
Secondary outcomes (2)
Sartorius score
HS severity score
Measured: after 6 treatments i.e. 6 months
Physician global assesment
HS severity score
Measured: after 6 treatments i.e. 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 2017
- Study start7 Aug 2017 (estimated)
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Aug 2019 (estimated)
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 Zealand University HospitalThe 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
- Parallel groups
- Model description
- Patients are randomized to treatment in either left or right side, using the other side as control.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203122
- Sponsor's protocol ID
- REG-115-2016
- Status last verified
- Jun 2017
- First submitted
- 27 Jun 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intense Pulsed Light Assisted Hair Removal Therapy on Mild and Moderate Cases of Hidrosadenitis Suppurativa
- ClinicalTrials.gov ID
- NCT03203122
- Acronym / sponsor ID
- REG-115-2016
- Conditions
- Hidradenitis Suppurativa, Acne Inversa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 7 Aug 2017 (estimated)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 29 Jun 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.
6 monthly treatments with IPL laser in patients with Hidradenitis Suppurativa. The effect in measured on several severity scores.
Detailed description
Patient suffering from bilateral HS in the axilla or groin area are threated with IPL laser monthly for 6 months.
Patients are randomized to treatment in either left or right side, the other side works as control.
No sham treatment, but observers are blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomized to treatment in either left or right side, using the other side as control.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: IPL laserPatients are randomized to treatment of either right or left side. The other side works as control |
| Comparator Group | Sham comparator | Other: No sham treatmentPatients are randomized to treatment in either right or left side. The other side works as control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Bilateral HS in the axilla or groin area
- Fitzpatrick skin type I-II
Key exclusion criteria (2 listed)
- Pregnant
- Unable to understand or communicate with study personnel
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 |
|---|---|---|
| IPL laserIPL laser monthly. Vertical and horizontal treatment, one pass over. Settings according to fitzpatrick skin type | Other | Study group |
| No sham treatmentThe treatment is slightly painful, and noisy. Sham treatment impossible | Other | Comparator Group |
Primary outcome
HiScore
Time frame: After 6 treatments i.e. 6 months
50 % reduction in abcesses and draining fistual
2 secondary outcomes
Sartorius score
Time frame: after 6 treatments i.e. 6 months
Physician global assesment
Time frame: after 6 treatments i.e. 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Individual participant dataSharing planned: No. Will not be shared
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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.
Gregor Jemec, DMSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPL laser in people with Hidradenitis Suppurativa and Acne Inversa, run by Zealand University Hospital at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 29 Jun 2017. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Riis, MD (47322672, pmik@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HiScore (time frame: After 6 treatments i.e. 6 months). 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 29 Jun 2017.