NCT03203122

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 7, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

June 27, 2017

Last Update Submit

June 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • HiScore

    50 % reduction in abcesses and draining fistual

    After 6 treatments i.e. 6 months

Secondary Outcomes (2)

  • Sartorius score

    after 6 treatments i.e. 6 months

  • Physician global assesment

    after 6 treatments i.e. 6 months

Study Arms (2)

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

IPL laser monthly. Vertical and horizontal treatment, one pass over. Settings according to fitzpatrick skin type

Study group

The treatment is slightly painful, and noisy. Sham treatment impossible

Comparator Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral HS in the axilla or groin area
  • Fitzpatrick skin type I-II

You may not qualify if:

  • Pregnant
  • Unable to understand or communicate with study personnel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Zealland

Roskilde, 4000, Denmark

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Central Study Contacts

Peter Riis, MD

CONTACT

Gregor Jemec, DMSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Outcome assesor and primary invstigator are blinded and not present at treatments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients are randomized to treatment in either left or right side, using the other side as control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2017

First Posted

June 29, 2017

Study Start

August 7, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2019

Last Updated

June 29, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Will not be shared

Locations