NCT00395187

Brief Summary

This study will investigate the efficacy of Photodynamic Therapy (PDT), which is the therapeutic use of photochemical reactions, in treating hidradenitis suppurativa (HS), a chronic inflammatory condition affecting areas of skin with sweat glands. We expect that PDT is effective in treating HS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

October 10, 2007

Status Verified

October 1, 2007

First QC Date

November 1, 2006

Last Update Submit

October 4, 2007

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

  • Active and inactive lesion count

    0,1,2,3,4,8,16 weeks

Secondary Outcomes (1)

  • Regional disease severity will be assessed at each visit. Global Severity Score will be assigned by investigator. Assessed at all 6 visits, Patient self -assessment (DLQI) at visits 4-6,-Digital photographs-all 6 visits,Safety/adverse event monitoring.

    0,1,2,3,4,8,16 weeks

Interventions

Photodynamic TherapyPROCEDURE

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • multiple lesions consistent with HS in axillae/groin
  • history of no or poor response to at least one treatment modality
  • no active treatment in the 2 weeks prior to study initiation

You may not qualify if:

  • Pregnancy/lactation
  • photosensitizing drug use within 30 days of start of study
  • active infection needing antibiotics
  • history of porphyria or photosensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Daniel Aires, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2006

First Posted

November 2, 2006

Study Start

October 1, 2006

Study Completion

September 1, 2007

Last Updated

October 10, 2007

Record last verified: 2007-10

Locations

US(1)