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Trial record 1 of 1 for:    Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa
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Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa

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ClinicalTrials.gov Identifier: NCT03203122
Recruitment Status : Unknown
Verified June 2017 by Zealand University Hospital.
Recruitment status was:  Recruiting
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Study Description
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Brief Summary:
6 monthly treatments with IPL laser in patients with Hidradenitis Suppurativa. The effect in measured on several severity scores.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Acne Inversa Other: IPL laser Other: No sham treatment Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomized to treatment in either left or right side, using the other side as control.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Outcome assesor and primary invstigator are blinded and not present at treatments.
Primary Purpose: Treatment
Official Title: The Effect of Intense Pulsed Light Assisted Hair Removal Therapy on Mild and Moderate Cases of Hidrosadenitis Suppurativa
Estimated Study Start Date : August 7, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. HiScore [ Time Frame: After 6 treatments i.e. 6 months ]
    50 % reduction in abcesses and draining fistual


Secondary Outcome Measures :
  1. Sartorius score [ Time Frame: after 6 treatments i.e. 6 months ]
    HS severity score

  2. Physician global assesment [ Time Frame: after 6 treatments i.e. 6 months ]
    HS severity score


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203122


Contacts
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Contact: Peter Riis, MD 47322672 pmik@regionsjaelland.dk
Contact: Gregor Jemec, DMSc gbj@regíonsjaelland.dk

Locations
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Denmark
University hospital Zealland Recruiting
Roskilde, Denmark, 4000
Contact: Peter T Riis, MD    47322672    pmik@regionsjaelland.dk   
Contact: Linnea Thorlacius, MD    47322671    lrit@regionsjaelland.dk   
Sponsors and Collaborators
Zealand University Hospital
More Information
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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03203122    
Other Study ID Numbers: REG-115-2016
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
 Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration