Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00985829
Other study ID # pdt bcc1
Secondary ID
Status Completed
Phase Phase 1
First received September 26, 2009
Last updated November 18, 2009
Start date January 2008
Est. completion date March 2009

Study information

Verified date November 2009
Source hahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date March 2009
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Response to Photodynamic Therapy immediately after termination of treatment course (with an average of 5 month after initiation of PDT) Yes
Secondary Histologic Resolution of Lesion immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT) Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04552990 - Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma Phase 2
Completed NCT04229277 - Fast Track Diagnosis of Skin Cancer by Advanced Imaging N/A
Completed NCT05608902 - Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study (DOCTOBA)
Completed NCT05077033 - Intratumoral phIL12 GET Phase 1
Active, not recruiting NCT04928222 - Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II) Phase 1/Phase 2
Recruiting NCT04929535 - Hydrogen Peroxide Trial to Investigate the Efficacy of 30%H2O2 as a Topical Application Before Definitive Treatment Phase 2
Completed NCT02662244 - Long-pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma N/A
Completed NCT00959647 - A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study Phase 2
Completed NCT00793169 - Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
Completed NCT00586040 - Photochemical Tissue Bonding Phase 2
Completed NCT00473343 - Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma Phase 3
Active, not recruiting NCT06024629 - cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study
Not yet recruiting NCT05324202 - New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management N/A
Withdrawn NCT04099446 - A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer
Completed NCT02902822 - Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo N/A
Completed NCT01260987 - Fractional CO2 Laser Assisted Photodynamic Therapy Phase 2/Phase 3
Completed NCT01208831 - An East Asian Study of LDE225 Phase 1
Completed NCT01201915 - A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma Phase 2
Completed NCT01014819 - A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions N/A
Completed NCT00472043 - PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Call Carcinoma Phase 3