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Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa, Acne Inversa

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
IPL laser
No sham treatment
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital ZeallandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Study group

Comparator Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

HiScore
50 % reduction in abcesses and draining fistual

Secondary Outcome Measures

Sartorius score
HS severity score
Physician global assesment
HS severity score

Full Information

First Posted
June 27, 2017
Last Updated
June 28, 2017
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03203122
Brief Title
Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa
Official Title
The Effect of Intense Pulsed Light Assisted Hair Removal Therapy on Mild and Moderate Cases of Hidrosadenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 7, 2017 (Anticipated)
Primary Completion Date
August 1, 2018 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa, Acne Inversa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomized to treatment in either left or right side, using the other side as control.
Masking
InvestigatorOutcomes Assessor
Masking Description
Outcome assesor and primary invstigator are blinded and not present at treatments.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients are randomized to treatment of either right or left side. The other side works as control
Arm Title
Comparator Group
Arm Type
Sham Comparator
Arm Description
Patients are randomized to treatment in either right or left side. The other side works as control
Intervention Type
Other
Intervention Name(s)
IPL laser
Intervention Description
IPL laser monthly. Vertical and horizontal treatment, one pass over. Settings according to fitzpatrick skin type
Intervention Type
Other
Intervention Name(s)
No sham treatment
Intervention Description
The treatment is slightly painful, and noisy. Sham treatment impossible
Primary Outcome Measure Information:
Title
HiScore
Description
50 % reduction in abcesses and draining fistual
Time Frame
After 6 treatments i.e. 6 months
Secondary Outcome Measure Information:
Title
Sartorius score
Description
HS severity score
Time Frame
after 6 treatments i.e. 6 months
Title
Physician global assesment
Description
HS severity score
Time Frame
after 6 treatments i.e. 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Riis, MD
Phone
47322672
Email
pmik@regionsjaelland.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Gregor Jemec, DMSc
Email
gbj@regíonsjaelland.dk
Facility Information:
Facility Name
University hospital Zealland
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter T Riis, MD
Phone
47322672
Email
pmik@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Linnea Thorlacius, MD
Phone
47322671
Email
lrit@regionsjaelland.dk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Will not be shared

Learn more about this trial

Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa

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