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

Microneedling With 5-Fluorouracil Versus Intralesional 5-Fluorouracil or Corticosteroids 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.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Scar; Keloid Scars
• Intervention / Treatment: Procedure: Microneedling with 5-Fluorouracil; Drug: Intralesional 5-fluorouracil; Drug: Intralesional Triamcinolone Acetonide; Procedure: Microneedling With saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • alexandria University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients diagnosed with HTSs or keloids

Exclusion Criteria:

• pregnant or lactating females, immunocompromised patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Microneedling with 5-Fluorouracil; Intervention Name: Microneedling With 5 Fluorouracil Intervention Type: Procedure	Procedure: Microneedling with 5-Fluorouracil; Undiluted 5-FU was applied topically after microneedling
Active Comparator: Intralesional 5-Fluorouracil; Intervention name: Intralesional 5-Fluorouracil Intervention Type: drug	Drug: Intralesional 5-fluorouracil; undiluted 5-fluorouracil was applied topically
Active Comparator: Intralesional Corticosteroids; Intervention name: Intralesional Triamcinolone Acetonide Intervention type: drug	Drug: Intralesional Triamcinolone Acetonide; Triamcinolone acetonide was administered intralesionally
Placebo Comparator: Microneedling with normal saline; Intervention name: Microneedling with normal saline Intervention type: Procedure	Procedure: Microneedling With saline; saline was applied after microneedling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	3 weeks

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Shaimaa Ismail Omar, MD, Alexandria University; Study Director: Yehia Farouk Al-Jarem, MD, Alexandria University; Study Chair: Alaa Tarek Abd El Maksoud, MBBCH, Alexandria University; Study Chair: Marwa Essawy, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): March 8, 2025

Study Registration Dates

• First Submitted: July 17, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: 5-Fluorouracil; Microneedling; Hypertrophic scars; Corticosteroids; keloid
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Cicatrix; Fibrosis; Collagen Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Cicatrix, Hypertrophic; Keloid; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Punctures; Complementary Therapies; Physical Therapy Modalities; Inorganic Chemicals; Chlorine Compounds; Pyrimidines; Rehabilitation; Uracil; Pyrimidinones; Sodium Compounds; Chlorides; Hydrochloric Acid; Fluorouracil; Sodium Chloride; Percutaneous Collagen Induction
• Other Study ID Numbers: 0107751; 00012098 (Other Identifier: (IRB))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: PD will not be shared due to participant confidentiality and ethical considerations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No