Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

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

Detailed Description
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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.

Official Title
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Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

Conditions
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Basal Cell Carcinoma

Intervention / Treatment
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* Radiation: photodynamic therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basal cell carcinoma, photodynamic therapy, photo chemotherapy, basal cell epithelioma