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

NCT ID: NCT06150144

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-25
• Study Completion Date: 2025-05-25

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.

Conditions

Basal Cell Carcinoma; BCC

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with intralesional 5-fluorouracil.

Group Type: EXPERIMENTAL

5-Fluorouracil

Intervention Type: DRUG

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.

Patients with Surgery

Group Type: ACTIVE_COMPARATOR

SURGERY

Intervention Type: OTHER

Total excision of the lesion

Interventions

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.

Intervention Type: DRUG

SURGERY

Total excision of the lesion

Intervention Type: OTHER

Other Intervention Names

5-FU

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aleppo University Hospital

UNKNOWN

Sponsor Role: collaborator

University of Aleppo

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Arnaout

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noura Abdulrahman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria

Rama Haj mharram, M.D.

Role: STUDY_DIRECTOR

Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria

Ahmad Yamen Arnaout, M.D.

Role: STUDY_DIRECTOR

Faculty of Medicine, University of Aleppo, Aleppo, Syria.

Silva Ishkhanian, PhD

Role: STUDY_DIRECTOR

Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria

Locations

Ibrahim Arnaout

Aleppo, , Syria

Site Status: RECRUITING

Countries

Syria

Central Contacts

Ibrahim Arnaout, M.D. Candidate

Role: CONTACT

ibrahim.arnaout25@gmail.com

+963993279977

George Zakhour, M.D. Candidate

Role: CONTACT

geo.zakhour@yahoo.com

+963 959 115 307

Facility Contacts

Ibrahim Arnaout, M.D.

Role: primary

ibrahim.arnaout25@gmail.com

+963993279977

Other Identifiers

intralesional 5-FU for BCC

Identifier Type: -

Identifier Source: org_study_id