Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa

• Sponsor: Zealand University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03203122
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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.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: Aug 7, 2017
• Anticipated Primary Completion Date: Aug 1, 2018
• Anticipated Study Completion Date: Aug 1, 2019

Arms and Interventions

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

Primary Outcome Measures

1. HiScore [After 6 treatments i.e. 6 months]

   50 % reduction in abcesses and draining fistual

Secondary Outcome Measures

1. Sartorius score [after 6 treatments i.e. 6 months]

   HS severity score

2. Physician global assesment [after 6 treatments i.e. 6 months]

   HS severity score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University hospital Zealland	Roskilde		Denmark	4000

Sponsors and Collaborators

• Zealand University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zealand University Hospital
• ClinicalTrials.gov Identifier: NCT03203122
• Other Study ID Numbers: REG-115-2016
• First Posted: Jun 29, 2017
• Last Update Posted: Jun 29, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hidradenitis Suppurativa; Hidradenitis

Study Results

No Results Posted as of Jun 29, 2017