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Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00988455
Enrollment
28
Registered
2009-10-02
Start date
2008-01-31
Completion date
2009-08-31
Last updated
2009-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma

Keywords

basal cell carcinoma, photodynamic therapy, photo chemotherapy, basal cell epithelioma

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.

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.

Interventions

RADIATIONphotodynamic therapy

5-ALA cream 20% topical administration + photodynamic therapy (red light) 120 j/cm2

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

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

MeasureTime frame
response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination)1 year

Secondary

MeasureTime frame
recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026