Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa

NCT ID: NCT03203122

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2019-08-01

Brief Summary

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6 monthly treatments with IPL laser in patients with Hidradenitis Suppurativa. The effect in measured on several severity scores.

Detailed Description

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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

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Hidradenitis Suppurativa Acne Inversa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are randomized to treatment in either left or right side, using the other side as control.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Outcome assesor and primary invstigator are blinded and not present at treatments.

Study Groups

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Study group

Patients are randomized to treatment of either right or left side. The other side works as control

Group Type EXPERIMENTAL

IPL laser

Intervention Type OTHER

IPL laser monthly. Vertical and horizontal treatment, one pass over. Settings according to fitzpatrick skin type

Comparator Group

Patients are randomized to treatment in either right or left side. The other side works as control

Group Type SHAM_COMPARATOR

No sham treatment

Intervention Type OTHER

The treatment is slightly painful, and noisy. Sham treatment impossible

Interventions

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IPL laser

IPL laser monthly. Vertical and horizontal treatment, one pass over. Settings according to fitzpatrick skin type

Intervention Type OTHER

No sham treatment

The treatment is slightly painful, and noisy. Sham treatment impossible

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Bilateral HS in the axilla or groin area
* Fitzpatrick skin type I-II

Exclusion Criteria

* Pregnant
* Unable to understand or communicate with study personnel
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University hospital Zealland

Roskilde, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Peter Riis, MD

Role: CONTACT

Phone: 47322672

Email: [email protected]

Gregor Jemec, DMSc

Role: CONTACT

Email: gbj@regíonsjaelland.dk

Facility Contacts

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Peter T Riis, MD

Role: primary

Linnea Thorlacius, MD

Role: backup

Other Identifiers

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REG-115-2016

Identifier Type: -

Identifier Source: org_study_id