Intralesional Cryosurgery Alone Versus Combined With 5-FU and Triamcinolone for Keloids

ConditionKeloid

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAssiut University

About this trial

evaluate the efficacy and safety of intralesional cryosurgery alone compared with intralesional cryosurgery combined with intralesional 5-fluorouracil and triamcinolone acetonide in the treatment of keloids.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years) with clinically diagnosed keloids .

Keloids of size 1-10 cm in greatest dimension .

Keloids of at least one year duration

Disqualifiers

Females who are pregnant, planning pregnancy, or lactating .

Hypertrophic scars .

Chronic kidney or liver disease (relevant for 5-FU safety) .

Patients with active inflammation, infection, or ulcer at or around the keloid or Lesions suspicious for malignancy .

Trial design

Design model

Parallel

Treatments tested in this trial

Intralesional Cryotherapy + Saline Injection
Procedure/Surgery
Patients will receive a single session of intralesional cryotherapy followed by intralesional saline injection as a placebo. Saline injections will be repeated at 4-week intervals for a total of four sessions to maintain blinding and follow-up consistency with the experimental group. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS
Intralesional Cryotherapy + TAC/5-FU Injection
Procedure/Surgery
Patients will receive a single session of intralesional cryotherapy followed immediately by intralesional injection of a combination of triamcinolone acetonide (TAC, 40 mg/mL) and 5-fluorouracil (5-FU, 50 mg/mL) in a ratio of 1:9. Further intralesional injections of TAC and 5-FU will be administered at 4-week intervals for a total of four sessions. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS.

Treatment groups

32 Participants

are divided into 2 treatment groups

Group A: Cryotherapy + Saline Injection (Placebo)Experimental treatment 1 intervention

Group B: Cryotherapy + TAC/5-FU InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in keloid size

Keloid severity will be assessed using the Vancouver Scar Scale (VSS), which evaluates vascularity, pigmentation, pliability, and height. Scores range from 0 to 13, with higher scores indicating more severe scarring. Assessment will be performed by blinded observers.

Time frame

12 weeks

Secondary outcomes

Patient Scar Assessment (PSAS)

Patient-reported outcomes will be evaluated using the Patient Scar Assessment Scale (PSAS), which assesses pain, pruritus, color, stiffness, thickness, and irregularity. Scores range from 6 to 60, with higher scores indicating worse scar quality.

Time frame

up to 12 weeks

Other outcomes

Change in dermoscopic vascular patterns and pigmentation

Dermoscopy will be used to document and evaluate changes in vascular patterns, pigmentation, and structural features of the keloid. Observations will be compared between baseline and 12 weeks to assess changes

Time frame

up to 12 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Northwest Biotherapeutics

Sponsor institution

Source ClinicalTrials.gov

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