Evaluation of Efficacy of Photodynamic Therapy in Basal C... | NCT00988455

Studies
Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up

NCT00988455

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Completed

Last Update Posted

Oct 2, 2009Estimated

Enrollment

28Actual

Phase

Phase 1Phase 2

Conditions

Basal Cell Carcinoma

Interventions

photodynamic therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
zthr

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Sep 29, 2009

First Submission Date that Met QC Criteria

Oct 1, 2009

First Posted Date

Oct 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2009

Last Update Posted Date

Oct 2, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Background and Aim:

Basal cell carcinoma (BCC) is the most common skin cancer .Photodynamic therapy _as a novel , non-invasive therapeutic approach _may be considered a valuable strategy. This study was designed with the aim of the evaluation of efficacy of PDT in treatment of BCC and recurrence rate after 6 months .

Materials and Methods:

This was a clinical trial which was done on 28 BCCs. Patients were treated with ALA-PDT monthly for 1-6 sessions and evaluated for clinical response,cosmetic results,recurrence rate and probable side effects.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BCC, ALA-PDT	Experimental	Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT	Radiation: photodynamic therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
photodynamic therapy	Radiation	5-ALA cream 20% topical administration + photodynamic therapy (red light) 120 j/cm2	BCC, ALA-PDT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination)		1 year

Secondary Outcomes

Measure	Description	Time Frame
recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically proven BCCs

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
zohreh Tehranchi-nia, assist.prof.	skin research center	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002280	Carcinoma, Basal Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010778	Photochemotherapy
C008848	1-phenyl-3,3-dimethyltriazene

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy
D010789	Phototherapy

Browse Leaves

Not provided

Browse Branches

Not provided