Basal Cell Carcinoma
Conditions
Keywords
basal cell carcinoma, photodynamic therapy, photo chemotherapy, basal cell epithelioma
Brief summary
The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate.
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.
Interventions
RADIATIONphotodynamic therapy
treatment of bcc with 5\_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response to Photodynamic Therapy | immediately after termination of treatment course (with an average of 5 month after initiation of PDT) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histologic Resolution of Lesion | immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT) | disappearance of the lesion in histologic examination |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Result | 1 month after termination of treatment course (with an average of 6 months after initiation of PDT) | 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 |
| Location of Lesion | baseline | — |
| BCC Type | baseline | superficial BCC (sBCC); pigmented BCC(pBCC);nodular BCC (nBCC) |
| Past Medical History of Radiotherapy | baseline | past medical history of radiotherapy to the site of tumor before its appearance(for another reason) |
Participant flow
Recruitment details
all patients with Histologically proven basal cell carcinoma (BCC) entered the study.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s) | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) |
|---|---|
| Age Continuous | 59.1 years STANDARD_DEVIATION 12.7 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
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
Time frame: immediately after termination of treatment course (with an average of 5 month after initiation of PDT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Clinical Response to Photodynamic Therapy | complete response | 9 lesions |
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Clinical Response to Photodynamic Therapy | partial response | 14 lesions |
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Clinical Response to Photodynamic Therapy | no response | 5 lesions |
Secondary
Histologic Resolution of Lesion
disappearance of the lesion in histologic examination
Time frame: immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)
Population: from those 9 lesions with clinically complete reponse , 3 lesions were biopsied and assessed histologically.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Histologic Resolution of Lesion | complete resolution in histologic examination | 3 lesions |
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Histologic Resolution of Lesion | not complete resolution in histologic examination | 0 lesions |
Other Pre-specified
BCC Type
superficial BCC (sBCC); pigmented BCC(pBCC);nodular BCC (nBCC)
Time frame: baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | BCC Type | nodular | 15 lesions |
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | BCC Type | pigmented | 7 lesions |
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | BCC Type | superficial | 6 lesions |
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
Time frame: 1 month after termination of treatment course (with an average of 6 months after initiation of PDT)
Population: cosmetic result was assessed among patients with complete response
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Cosmetic Result | excellent | 5 lesions |
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Cosmetic Result | good | 2 lesions |
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Cosmetic Result | moderate | 2 lesions |
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Cosmetic Result | poor | 0 lesions |
Other Pre-specified
Location of Lesion
Time frame: baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Location of Lesion | scalp | 13 lesions |
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Location of Lesion | face | 13 lesions |
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Location of Lesion | ear | 2 lesions |
Other Pre-specified
Past Medical History of Radiotherapy
past medical history of radiotherapy to the site of tumor before its appearance(for another reason)
Time frame: baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Past Medical History of Radiotherapy | positive | 17 lesions |
| Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) | Past Medical History of Radiotherapy | negative | 11 lesions |