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

Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150144
• Other study ID #: intralesional 5-FU for BCC
• Status: Recruiting
• Phase: Phase 3
• Start date: May 25, 2023
• Est. completion date: May 25, 2025

Study information

• Verified date: December 2023
• Source: University of Aleppo
• Contact: Ibrahim Arnaout, M.D. Candidate
• Phone: +963993279977
• Email: ibrahim.arnaout25[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 25, 2025
• Est. primary completion date: May 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• BCC
• Carcinoma
• Carcinoma, Basal Cell

Intervention

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:
• SURGERY
Total excision of the lesion

Locations

Country	Name	City	State
Syrian Arab Republic	Ibrahim Arnaout	Aleppo

Sponsors (2)

Lead Sponsor	Collaborator
University of Aleppo	Aleppo University Hospital

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histologic complete response rate	defined by absence of any tumor on the basis of histologic analysis of the excised specimen.	1 - 2 months
Secondary	Sides effect	The patient will be monitored and followed up for 365 days after the injection.	1 year