Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa

June 28, 2017 updated by: Zealand University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Patients are randomized to treatment of either right or left side. The other side works as control
Other: IPL laser
IPL laser monthly. Vertical and horizontal treatment, one pass over. Settings according to fitzpatrick skin type
Sham Comparator: Comparator Group
Patients are randomized to treatment in either right or left side. The other side works as control
Other: No sham treatment
The treatment is slightly painful, and noisy. Sham treatment impossible

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HiScore
Time Frame: After 6 treatments i.e. 6 months
50 % reduction in abcesses and draining fistual
After 6 treatments i.e. 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sartorius score
Time Frame: after 6 treatments i.e. 6 months
HS severity score
after 6 treatments i.e. 6 months
Physician global assesment
Time Frame: after 6 treatments i.e. 6 months
HS severity score
after 6 treatments i.e. 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 7, 2017

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

June 27, 2017

First Submitted That Met QC Criteria

June 28, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

June 29, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-115-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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