Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up
This study has been completed.
Sponsor:
Shaheed Beheshti Medical University
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00988455
First received: September 29, 2009
Last updated: October 1, 2009
Last verified: October 2009
| Tracking Information | |||||
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| First Received Date ICMJE | September 29, 2009 | ||||
| Last Updated Date | October 1, 2009 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00988455 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up | ||||
| Official Title ICMJE | Not Provided | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Basal Cell Carcinoma | ||||
| Intervention ICMJE | Radiation: photodynamic therapy
5-ALA cream 20% topical administration + photodynamic therapy (red light) 120 j/cm2
Other Name: PDT 1200L Waldman Medizintechnik, Villengen; Schwenningen, Germany |
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| Study Arm (s) | Experimental: BCC, ALA-PDT
Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT
Intervention: Radiation: photodynamic therapy |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 28 | ||||
| Completion Date | August 2009 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00988455 | ||||
| Other Study ID Numbers ICMJE | pdt bcc 2, zthr | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Zohreh Tehranchi-nia, assistant professor of dermatology | ||||
| Study Sponsor ICMJE | Shaheed Beheshti Medical University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Shaheed Beheshti Medical University | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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