NCT06150144

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2025

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

November 17, 2023

Last Update Submit

December 27, 2023

Conditions

Basal Cell CarcinomaBCC

Keywords

Surgical excisionBasal cell carcinomaclinical Trailintralesional 5-fluorouracil

Outcome Measures

Primary Outcomes (1)

  • Histologic complete response rate

    defined by absence of any tumor on the basis of histologic analysis of the excised specimen.

    1 - 2 months

Secondary Outcomes (1)

  • Sides effect

    1 year

Study Arms (2)

Patients with intralesional 5-fluorouracil.

EXPERIMENTAL
Drug: 5-Fluorouracil

Patients with Surgery

ACTIVE COMPARATOR
Other: SURGERY

Interventions

5-FluorouracilDRUG

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.

Also known as: 5-FU
Patients with intralesional 5-fluorouracil.
SURGERYOTHER

Total excision of the lesion

Patients with Surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibrahim Arnaout

Aleppo, Syria

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

FluorouracilSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Noura Abdulrahman, M.D.

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

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Central Study Contacts

Ibrahim Arnaout, M.D. Candidate

CONTACT

+963993279977ibrahim.arnaout25@gmail.com

George Zakhour, M.D. Candidate

CONTACT

+963 959 115 307geo.zakhour@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 29, 2023

Study Start

May 25, 2023

Primary Completion

May 25, 2025

Study Completion

May 25, 2025

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Not available to other researcher

Locations

SY(1)