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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03203122
Other study ID # REG-115-2016
Secondary ID
Status Recruiting
Phase N/A
First received June 27, 2017
Last updated June 28, 2017
Start date August 7, 2017
Est. completion date August 1, 2019

Study information

Verified date June 2017
Source Zealand University Hospital
Contact Peter Riis, MD
Phone 47322672
Email pmik@regionsjaelland.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 1, 2019
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
IPL laser
IPL laser monthly. Vertical and horizontal treatment, one pass over. Settings according to fitzpatrick skin type
No sham treatment
The treatment is slightly painful, and noisy. Sham treatment impossible

Locations

Country Name City State
Denmark University hospital Zealland Roskilde

Sponsors (1)

Lead Sponsor Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary HiScore 50 % reduction in abcesses and draining fistual After 6 treatments i.e. 6 months
Secondary Sartorius score HS severity score after 6 treatments i.e. 6 months
Secondary Physician global assesment HS severity score after 6 treatments i.e. 6 months
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