The Efficacy and Safety of Using Intralesional 5-fluorouracil for Basal Cell Carcinoma

December 27, 2023 updated by: Ibrahim Arnaout, University of Aleppo

The Efficacy and Safety of Using Intralesional 5-fluorouracil for Basal Cell Carcinoma: Clinical Trail

The investigators want to assess the safety and efficacy of using intralesional 5-FU for the management of different types of BCC (including all the types EXCEPT the infiltrative one), by estimating different outcomes after the intralesional administration of 5-FU to BCC patient. Patients are randomly selected from the outpatient dermatologic clinic in the Aleppo University Hospital (AUH) over a period of 12 months and then these patients are followed up over another 12 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Brief Description: The investigatorswant to assess the safety and efficacy of using intralesional 5-FU for the management of different types of BCC (including all the types EXCEPT the infiltrative one), by estimating different outcomes after the intralesional administration of 5-FU to BCC patient. Patients are randomly selected from the outpatient dermatologic clinic in the Aleppo University Hospital (AUH) over a period of 12 months and then these patients are followed up over another 12 months.

Detailed Description: Clinicians routinely consider surgical removal as the best and sometimes the only cost-effective treatment of Basal cell carcinoma, but several studies have discussed other promising treatment approaches for BCC including 5% 5-FU cream which is indicated for the treatment of superficial BCC, in addition many studies have investigated the efficacy of the combination of 5-FU with Imiquimode or cryoablation presenting promising results, however when searching the medical literature there was only few studies dealing with types other than superficial BCC, in addition intralesional administration of 5-FU alone was not thoroughly assessed so far even though there are some studies showing positive results suggesting 5-FU to be a cost-effective alternative to surgical excision, but as these papers are asking for further studies and stronger evidence the invistigators decided to conduct this study in accordance with the best recommendations reached by latest medical literature.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 5 Years to 90 Years (Child, Adult, Older Adult).
  • Volunteer to participate in study
  • Superficial lesion
  • Nodular lesion (x ≤ 1.5 cm) patients are seen at the outpatient Department or in the dermatology wards at Aleppo University Hospital (AUH) over 12 months' period.

Exclusion Criteria:

  • Ulcerative.
  • Nodular lesion (x ≥ 1.5 cm)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with intralesional 5-fluorouracil.
Drug: 5-Fluorouracil
The invistigators want to assess the safety and efficacy of using intralesional 5-FU for the management of different types of BCC (including all the types EXCEPT the infiltrative one), by estimating different outcomes after the intralesional administration of 5-FU to BCC patient. Patients are randomly selected from the outpatient dermatologic clinic in the Aleppo University Hospital (AUH) over a period of 12 months and then these patients are followed up over another 12 months.
Other Names:
  • 5-FU
Active Comparator: Patients with Surgery
Other: SURGERY
Total excision of the lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histologic complete response rate
Time Frame: 1 - 2 months
defined by absence of any tumor on the basis of histologic analysis of the excised specimen.
1 - 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sides effect
Time Frame: 1 year
The patient will be monitored and followed up for 365 days after the injection.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aleppo

Collaborators

Aleppo University Hospital

Investigators

  • Principal Investigator: Noura Abdulrahman, M.D., Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria
  • Study Director: Rama Haj mharram, M.D., Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria
  • Study Director: Ahmad Yamen Arnaout, M.D., Faculty of Medicine, University of Aleppo, Aleppo, Syria.
  • Study Director: Silva Ishkhanian, PhD, Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2023

Primary Completion (Estimated)

May 25, 2025

Study Completion (Estimated)

May 25, 2025

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • intralesional 5-FU for BCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not available to other researcher

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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