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Trial record 47 of 51 for:    "hidradenitis suppurativa" OR "acne inversa"

Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa

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

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
Hidradenitis Suppurativa Acne Inversa Other: IPL laser Other: No sham 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  (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
Anticipated 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

U.S. FDA Resources

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



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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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

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

Locations
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

Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03203122     History of Changes
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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration