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Completed

NCT Number: NCT00985829

Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

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

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photodynamic therapy

Radiation

treatment of bcc with 5_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly

Other names: PDT 1200L Waldman Medizintechnik; Schwenningen, Germany

Primary outcomes

  1. Clinical Response to Photodynamic Therapy

    Time frame: 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 outcomes

  1. Histologic Resolution of Lesion

    Time frame: 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 outcomes

  1. Cosmetic Result

    Time frame: 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

  2. Location of Lesion

    Time frame: baseline

  3. BCC Type

    Time frame: baseline

    superficial BCC (sBCC); pigmented BCC(pBCC);nodular BCC (nBCC)

  4. Past Medical History of Radiotherapy

    Time frame: baseline

    past medical history of radiotherapy to the site of tumor before its appearance(for another reason)

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Sep 28, 2009
Registry last updated
Dec 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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