Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate.

Study Overview

• Status: Completed
• Conditions: Basal Cell Carcinoma
• Intervention / Treatment: Radiation: photodynamic therapy

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 factors that may affect response rate.

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 and probable side effects.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BCC, ALA-PDT; Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT	Radiation: photodynamic therapy; treatment of bcc with 5_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly; Other Names: PDT 1200L Waldman Medizintechnik; Schwenningen, Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response to Photodynamic Therapy	categorized in 3 groups: complete response: there was no visible or palpable lesion; partial response: there was a visible or palpable lesion but the diameter of the lesion had reduced; no response: there was a visible or palpable lesion and the diameter of the lesion had not reduced	immediately after termination of treatment course (with an average of 5 month after initiation of PDT)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histologic Resolution of Lesion	disappearance of the lesion in histologic examination	immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic Result	excellent: no scarring, atrophy, or induration, slight or no redness or change in pigmentation compared to the adjacent skin; good: no scarring, atrophy, or induration, moderate redness or increase in pigmentation compared to the adjacent skin; moderate: slight to moderate scarring, atrophy, or induration; and poor: extensive scarring, atrophy, or induration	1 month after termination of treatment course (with an average of 6 months after initiation of PDT)
Location of Lesion		baseline
BCC Type	superficial BCC (sBCC); pigmented BCC(pBCC);nodular BCC (nBCC)	baseline
Past Medical History of Radiotherapy	past medical history of radiotherapy to the site of tumor before its appearance(for another reason)	baseline

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences
• Investigators: Principal Investigator: Zohreh Tehranchi-nia, assist.prof., Skin Research Center

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: September 26, 2009
• First Submitted That Met QC Criteria: September 26, 2009
• First Posted (Estimate): September 28, 2009

Study Record Updates

• Last Update Posted (Estimate): December 22, 2009
• Last Update Submitted That Met QC Criteria: November 18, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: photodynamic therapy; basal cell carcinoma; photo chemotherapy; basal cell epithelioma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: pdt bcc1; NCT00985829 (Other Grant/Funding Number: ShaheedBMU)