Clinical trial NCT06150144: The Efficacy and Safety of Using Intralesional 5-fluorouracil for Basal Cell Carcinoma
Official title: The Efficacy and Safety of Using Intralesional 5-fluorouracil for Basal Cell Carcinoma: Clinical Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Basal Cell Carcinoma
BCC
Keywords: Surgical excision
Basal cell carcinoma
clinical Trail
intralesional 5-fluorouracil
Lead sponsor: University of Aleppo
Sponsor class: OTHER
Collaborators: name: Aleppo University Hospital
First posted: 2023-11-29
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Histologic complete response rate
timeFrame: 1 - 2 months
Secondary outcomes:
measure: Sides effect
timeFrame: 1 year
Other outcomes:
Locations:
city: Aleppo
country: Syrian Arab Republic
facility: Ibrahim Arnaout
Study officials:
affiliation: Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria
name: Noura Abdulrahman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria
name: Rama Haj mharram, M.D.
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, University of Aleppo, Aleppo, Syria.
name: Ahmad Yamen Arnaout, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria
name: Silva Ishkhanian, PhD
role: STUDY_DIRECTOR
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