NCT00218829

Brief Summary

The purpose of this study is to registrate long time clinical and histological treatment response of basal cell carcinoma (BCC) lesions treated with one or two procedures of dimethylsulfoxide supported 5-aminolaevulinic acid photodynamic therapy (DMSO-PDT).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 1997

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

September 1, 1997

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

7.3 years

First QC Date

September 20, 2005

Last Update Submit

March 10, 2017

Conditions

Carcinoma, Basal Cell

Keywords

Photodynamic treatmentBasal cell carcinomaDMSO

Eligibility Criteria

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

You may qualify if:

  • histological verified bcc.
  • one or two PDT treatments with treatment interval no longer than two weeks.
  • lesion complete response three months after therapy.

You may not qualify if:

  • pregnant.
  • Gorlin's syndrome.
  • morpheaform or pigmented bcc.
  • histology older than one year.
  • tumour infiltration more than four mm.
  • previous PDT treated lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Christensen E, Skogvoll E, Viset T, Warloe T, Sundstrom S. Photodynamic therapy with 5-aminolaevulinic acid, dimethylsulfoxide and curettage in basal cell carcinoma: a 6-year clinical and histological follow-up. J Eur Acad Dermatol Venereol. 2009 Jan;23(1):58-66. doi: 10.1111/j.1468-3083.2008.02946.x. Epub 2008 Sep 18.

    PMID: 18803580RESULT

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Eidi Christensen, MD

    St. Olav University Hospital, Trondheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

September 1, 1997

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

March 14, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share