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

Phase 3

Recruiting

• Conditions: Basal Cell Carcinoma; BCC
• Interventions: Other: SURGERY; Drug: 5-Fluorouracil

• Registration Number: NCT06150144
• Lead Sponsor: University of Aleppo

Brief 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.

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 Timeline

• Study Start: 2023-05-25
• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-11-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2024-01-02
• Primary Completion: 2025-05-25
• Study Completion: 2025-05-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Patients with Surgery	SURGERY	-
Patients with intralesional 5-fluorouracil.	5-Fluorouracil	-

Primary Outcome Measures

Name	Time	Method
Histologic complete response rate	1 - 2 months	defined by absence of any tumor on the basis of histologic analysis of the excised specimen.

Secondary Outcome Measures

Name	Time	Method
Sides effect	1 year	The patient will be monitored and followed up for 365 days after the injection.

Trial Locations

Locations (1)

Ibrahim Arnaout; 🇸🇾 Aleppo, Syrian Arab Republic