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| ID | Type | Description | Link |
|---|---|---|---|
| NCT00985829 | Other Grant/Funding Number | ShaheedBMU |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCC, ALA-PDT | Experimental | Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| photodynamic therapy | Radiation | treatment of bcc with 5_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly |
|
| 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) |
| 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) |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zohreh Tehranchi-nia, assist.prof. | Skin Research Center | Principal Investigator |
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Exclusion Criteria:
rodent ulcer morphea type positive anti nuclear antibody test 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
all patients with Histologically proven basal cell carcinoma (BCC) entered the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | lesions | immediately after termination of treatment course (with an average of 5 month after initiation of PDT) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| local intolerable pain | Skin and subcutaneous tissue disorders | SNOMED CT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zohreh Tehranchi-nia, assist. prof | skin research center | +989121029415 | zohreh_tehranchi@yahoo.com |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| C008848 | 1-phenyl-3,3-dimethyltriazene |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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|
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Histologic Resolution of Lesion | disappearance of the lesion in histologic examination | from those 9 lesions with clinically complete reponse , 3 lesions were biopsied and assessed histologically. | Posted | Number | lesions | immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT) |
|
|
|
| Other Pre-specified | 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 | cosmetic result was assessed among patients with complete response | Posted | Number | lesions | 1 month after termination of treatment course (with an average of 6 months after initiation of PDT) |
|
|
|
| Other Pre-specified | Location of Lesion | Posted | Number | lesions | baseline |
|
|
|
| Other Pre-specified | BCC Type | superficial BCC (sBCC); pigmented BCC(pBCC);nodular BCC (nBCC) | Posted | Number | lesions | baseline |
|
|
|
| Other Pre-specified | Past Medical History of Radiotherapy | past medical history of radiotherapy to the site of tumor before its appearance(for another reason) | Posted | Number | lesions | baseline |
|
|
|
| 0 |
| 28 |
| 2 |
| 28 |
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| D018295 |
| Neoplasms, Basal Cell |
| Title | Measurements |
|---|
|
| poor |
|