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Trial Title:
The Efficacy and Safety of Using Intralesional 5-fluorouracil for Basal Cell Carcinoma
NCT ID:
NCT06150144
Condition:
Basal Cell Carcinoma
BCC
Conditions: Official terms:
Carcinoma
Carcinoma, Basal Cell
Fluorouracil
Conditions: Keywords:
Surgical excision
Basal cell carcinoma
clinical Trail
intralesional 5-fluorouracil
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
5-Fluorouracil
Description:
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.
Arm group label:
Patients with intralesional 5-fluorouracil.
Other name:
5-FU
Intervention type:
Other
Intervention name:
SURGERY
Description:
Total excision of the lesion
Arm group label:
Patients with Surgery
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.
Criteria for 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)
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ibrahim Arnaout
Address:
City:
Aleppo
Country:
Syrian Arab Republic
Status:
Recruiting
Contact:
Last name:
Ibrahim Arnaout, M.D.
Phone:
+963993279977
Email:
ibrahim.arnaout25@gmail.com
Investigator:
Last name:
George Zakhour, M.D.
Email:
Principal Investigator
Start date:
May 25, 2023
Completion date:
May 25, 2025
Lead sponsor:
Agency:
University of Aleppo
Agency class:
Other
Collaborator:
Agency:
Aleppo University Hospital
Agency class:
Other
Source:
University of Aleppo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06150144
