NCT07531056 Comparison Of Effectiveness Of Intralesional Injectioms Of 5 Flourouracil Alone Verses Its Cpmbination With Cryotherapy In The Treatment Of Keloids
| NCT ID | NCT07531056 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan |
| Condition | Keloids |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2025-12-22 |
| Primary Completion | 2026-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 88 participants in total. It began in 2025-12-22 with a primary completion date of 2026-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn how well intralesional 5 fluorouracil with cryotherapy works to treat keloids as compared to intralesional 5 fluorouracil alone on keloids. It will also learn about the safety of both these treatments. The main questions it aims to answer are: * What well does cryotherapy followed by intralesional 5 fluorouracil (5FU) work to treat keloids as compared to 5 fluorouracil (5FU) alone? * What is participant's satisfaction when treated with cryotherapy followed by intralesional 5 fluorouracil (5FU) as compared to 5 fluorouracil (5FU) alone? * What skin problems do participants have when treated with cryotherapy followed by intralesional 5 fluorouracil (5FU) and 5 fluorouracil (5FU) alone? Researchers will compare cryotherapy followed by intralesional 5 fluorouracil (5FU) with 5 fluorouracil (5FU) alone to see how well both work. Participants will be divided into two groups: For Group A: Cryotherapy will be done at lesion site followed by intralesional 5FU every 3 weekly. For Group B: Intralesional 5FU will be given at lesion site every 3 weekly. Keloids will be assessed at the start of trial and then after 12 weeks of treatment.
Eligibility Criteria
Inclusion Criteria: * Patients willing to participate in the study * Patients of age group of 18 -50 years. * Patients having symptomatic keloids i.e., having pain, pruritus, restriction of movement, scar tension or disfigurement. Exclusion Criteria :• Pregnant women or lactating women * Patients with history of hepatic, renal, cardiac diseases or chronic diarrhea. * Patients on immunosuppressant medications due to other diseases * Patients having myelosuppression checked by CBC. * Patient taking warfarin. * Patients with history of hypersensitivity to 5FU.
Frequently Asked Questions
Who can join the NCT07531056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Keloids. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07531056 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07531056 currently recruiting?
Yes, NCT07531056 is actively recruiting participants. Visit ClinicalTrials.gov or contact Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan to inquire about joining.
Where is the NCT07531056 trial being conducted?
This trial is being conducted at Chak Eighty-seven -Twelve Left, Pakistan.
Who is sponsoring the NCT07531056 clinical trial?
NCT07531056 is sponsored by Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan. The trial plans to enroll 88 participants.