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

Sponsor

University of Aleppo (Other)

Overall Status

Recruiting

CT.gov ID

NCT06150144

Collaborator

Aleppo University Hospital (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Basal Cell Carcinoma BCC	Drug: 5-Fluorouracil Other: SURGERY	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 25, 2023

Anticipated Primary Completion Date :

May 25, 2025

Anticipated Study Completion Date :

May 25, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Treat the lesion completely [1 - 2 months]
The patient will be taken biopsy from the lesion after the lesion is disappeared

Secondary Outcome Measures

Sides effect [1 year]
The patient will be monitored and followed up for 365 days after the injection.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ibrahim Arnaout	Aleppo		Syrian Arab Republic

Sponsors and Collaborators

University of Aleppo
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