NCT00988455

Brief Summary

The purpose of this study is to evaluate the efficacy of photodynamic therapy (PDT)in treatment of Basal cell carcinoma (BCC) and recurrence rate after 6 months.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
Last Updated

October 2, 2009

Status Verified

October 1, 2009

Enrollment Period

1.2 years

First QC Date

September 29, 2009

Last Update Submit

October 1, 2009

Conditions

Basal Cell Carcinoma

Keywords

basal cell carcinomaphotodynamic therapyphoto chemotherapybasal cell epithelioma

Outcome Measures

Primary Outcomes (1)

  • response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination)

    1 year

Secondary Outcomes (1)

  • recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up

    1 year

Study Arms (1)

BCC, ALA-PDT

EXPERIMENTAL

Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT

Radiation: photodynamic therapy

Interventions

photodynamic therapyRADIATION

5-ALA cream 20% topical administration + photodynamic therapy (red light) 120 j/cm2

Also known as: PDT 1200L Waldman Medizintechnik, Villengen; Schwenningen, Germany
BCC, ALA-PDT

Eligibility Criteria

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

You may qualify if:

  • Histologically proven BCCs

You may not qualify if:

  • Rodent ulcer
  • Morphea type
  • ANA +
  • History of photosensitivity or photodermatosis or ingestion of phototoxic drugs during last month
  • Pregnancy
  • Breast feeding
  • Age\< 18
  • History of another therapeutic intervention for bcc during last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Photochemotherapy1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • zohreh Tehranchi-nia, assist.prof.

    skin research center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2009

First Posted

October 2, 2009

Study Start

January 1, 2008

Primary Completion

March 1, 2009

Study Completion

August 1, 2009

Last Updated

October 2, 2009

Record last verified: 2009-10