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Completed

NCT Number: NCT07718269

Microneedling vs. 5-Fluorouracil or Steroid Injections for Hypertrophic Scars and Keloids

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.

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Key information

Conditions

Keloid Scars Cicatrix Cicatrix, Hypertrophic Collagen Diseases Connective Tissue Diseases Fibrosis Hypertrophic Scar Keloid Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

alexandria University Hospital

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed with HTSs or keloids

Exclusion criteria

  • pregnant or lactating females, immunocompromised patients

Treatment and study plan

Microneedling with 5-Fluorouracil

Procedure

Undiluted 5-FU was applied topically after microneedling

Intralesional 5-fluorouracil

Drug

undiluted 5-fluorouracil was applied topically

Intralesional Triamcinolone Acetonide

Drug

Triamcinolone acetonide was administered intralesionally

Microneedling With saline

Procedure

saline was applied after microneedling

Primary outcomes

  1. Vancouver Scar Scale

    Time frame: 3 weeks

    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.

  2. ImageJ Analysis

    Time frame: 3 weeks

    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.

Secondary outcomes

  1. Patient's satisfaction score

    Time frame: 3 weeks

    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

  2. visual analogue scale

    Time frame: 3 weeks

    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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Microneedling With 5-Fluorouracil Versus Intralesional 5-Fluorouracil or Corticosteroids for Hypertrophic Scars and Keloids

Acronym: MIST

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 21, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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