Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa | NCT03203122

Studies
Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa

NCT03203122

Sponsor

Zealand University Hospital

Status

Unknown status

Last Update Posted

Jun 29, 2017Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Hidradenitis Suppurativa
Acne Inversa

Interventions

IPL laser
No sham treatment

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 7, 2017Estimated

Primary Completion Date

Aug 1, 2018Estimated

Completion Date

Aug 1, 2019Estimated

First Submitted Date

Jun 27, 2017

First Submission Date that Met QC Criteria

Jun 28, 2017

First Posted Date

Jun 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2017

Last Update Posted Date

Jun 29, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Patients are randomized to treatment of either right or left side. The other side works as control	Other: IPL laser
Comparator Group	Sham Comparator	Patients are randomized to treatment in either right or left side. The other side works as control	Other: No sham treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IPL laser	Other	IPL laser monthly. Vertical and horizontal treatment, one pass over. Settings according to fitzpatrick skin type	Study group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Riis, MD	Contact	47322672		pmik@regionsjaelland.dk
Gregor Jemec, DMSc	Contact			gbj@regíonsjaelland.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital Zealland	Recruiting	Roskilde		4000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Will not be shared

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017497	Hidradenitis Suppurativa

Ancestor Terms

ID	Term
D017192	Skin Diseases, Bacterial
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided