A Phase 4 interventional study of Microneedling with 5-Fluorouracil and Intralesional 5-fluorouracil in Keloid Scars and Hypertrophic Scar, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Alexandria University · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to learn about the efficacy and safety of microneedling-assisted 5-fluorouracil delivery in comparison with intralesional 5-fluorouracil, intralesional corticosteroid, and microneedling with saline for the treatment of pathological scars.
Hypertrophic scars and keloids are dermal fibroproliferative disorders unique to humans. They are common and usually occur following burns, trauma, inflammation, or surgery, but sometimes occur spontaneously. Despite an array of therapeutic approaches for scar therapy such as surgical excision, occlusive dressings, topical and intralesional corticosteroids, interferon, cryosurgery, radiation, pressure therapy, laser therapy, retinoic acid, and silicone gel sheeting, no single method provides complete benefit. For this reason, the medical care of HTSs and keloids remains clinically challenging. The study was conducted on 60 patients complaining of HTSs \& keloids.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 60 is above the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention Name: Microneedling With 5 Fluorouracil Intervention Type: Procedure
Procedure: Microneedling with 5-Fluorouracil
Intervention name: Intralesional 5-Fluorouracil Intervention Type: drug
Drug: Intralesional 5-fluorouracil
Intervention name: Intralesional Triamcinolone Acetonide Intervention type: drug
Drug: Intralesional Triamcinolone Acetonide
Intervention name: Microneedling with normal saline Intervention type: Procedure
Procedure: Microneedling With saline
Undiluted 5-FU was applied topically after microneedling
undiluted 5-fluorouracil was applied topically
Triamcinolone acetonide was administered intralesionally
saline was applied after microneedling
Vancouver Scar Scale
To detect the Change in scar severity assessed by the Vancouver Scar Scale based on four scar characteristics (vascularity 0-3, pliability 0-5, height 0-3, pigmentation 0-2) with the minimum total score 0 (normal) and the maximum total score 13 (most severe scar). Higher scores after treatment mean worse outcome.
Time frame: 3 weeks
ImageJ Analysis
To objectively assess scar surface area. To quantify treatment effect, the percentage of change in scar area was calculated for each patient using the formula: ■("Percentage of change=" ("Post treatment area - Baseline area" /"Baseline area" )"×100" ), Higher scores mean worse outcomes.
Time frame: 3 weeks
Patient's satisfaction score
grade 0 (No satisfaction), grade I (poor less than 25%), grade II (fair 25-50%), grade III (Good 51-75%) and grade IV (Excellent 76-100%). The minimum total score 0 and the maximum total score 100. The higher scores mean a better outcome
Time frame: 3 weeks
visual analogue scale
to assess pain and pruritus. The minimum score is 0 indicated no pain or itching and the maximum score 10 represented the most severe pain or itching. The higher score mean a worse outcome
Time frame: 3 weeks
Plan to share: No — PD will not be shared due to participant confidentiality and ethical considerations
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Jan 2024, 12 months.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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