NCT01015898

Brief Summary

The purpose of this study is to evaluate the efficacy of photodynamic therapy in treatment of Basal cell carcinoma (BCC) and factors that affect response rate.

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

Shorter than P25 for phase_1

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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
Last Updated

November 18, 2009

Status Verified

November 1, 2009

Enrollment Period

6 months

First QC Date

November 17, 2009

Last Update Submit

November 17, 2009

Conditions

Basal Cell Carcinoma

Keywords

basal cell carcinomaphotodynamic therapyphoto chemotherapybasal cell epithelioma

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

treatment of bcc with 5\_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly

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

November 17, 2009

First Posted

November 18, 2009

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

November 18, 2009

Record last verified: 2009-11