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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06150144
Other study ID # intralesional 5-FU for BCC
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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