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

Last updated: December 27, 2023
Sponsor: University of Aleppo
Overall Status: Active - Recruiting

Phase

3

Condition

Cancer/tumors

Carcinoma

Warts

Treatment

SURGERY

5-Fluorouracil

Clinical Study ID

NCT06150144
intralesional 5-FU for BCC
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thedermatology wards at Aleppo University Hospital (AUH) over 12 months' period.

Exclusion

Exclusion Criteria:

  • Ulcerative.
  • Nodular lesion (x ≥ 1.5 cm)

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: SURGERY
Phase: 3
Study Start date:
May 25, 2023
Estimated Completion Date:
May 25, 2025

Study 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.

Connect with a study center

  • Ibrahim Arnaout

    Aleppo,
    Syrian Arab Republic

    Active - Recruiting

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