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

NCT07718269 | Completed Phase 4

• 2 other identifiers: 010775100012098
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Keloid Scars; Hypertrophic Scar

Keywords

keloid; Hypertrophic scars; Microneedling; 5-Fluorouracil; Corticosteroids

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Patient's satisfaction score

  3 weeks

• visual analogue scale

  3 weeks

Study Arms (4)

Microneedling with 5-Fluorouracil

ACTIVE COMPARATOR

Intervention Name: Microneedling With 5 Fluorouracil Intervention Type: Procedure

Procedure: Microneedling with 5-Fluorouracil

Intralesional 5-Fluorouracil

ACTIVE COMPARATOR

Intervention name: Intralesional 5-Fluorouracil Intervention Type: drug

Drug: Intralesional 5-fluorouracil

Intralesional Corticosteroids

ACTIVE COMPARATOR

Intervention name: Intralesional Triamcinolone Acetonide Intervention type: drug

Drug: Intralesional Triamcinolone Acetonide

Microneedling with normal saline

PLACEBO COMPARATOR

Intervention name: Microneedling with normal saline Intervention type: Procedure

Procedure: Microneedling With saline

Interventions

Microneedling with 5-Fluorouracil PROCEDURE

Undiluted 5-FU was applied topically after microneedling

Microneedling with 5-Fluorouracil

Intralesional 5-fluorouracil DRUG

undiluted 5-fluorouracil was applied topically

Intralesional 5-Fluorouracil

Microneedling With saline PROCEDURE

saline was applied after microneedling

Microneedling with normal saline

Intralesional Triamcinolone Acetonide DRUG

Triamcinolone acetonide was administered intralesionally

Intralesional Corticosteroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diagnosed with HTSs or keloids

You may not qualify if:

• pregnant or lactating females, immunocompromised patients

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

alexandria University Hospital

Alexandria, Egypt

Location

MeSH Terms

Conditions

Keloid; Cicatrix, Hypertrophic

Interventions

Percutaneous Collagen Induction; Fluorouracil; Sodium Chloride

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Shaimaa Ismail Omar, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Yehia Farouk Al-Jarem, MD

  Alexandria University

  STUDY DIRECTOR

• Alaa Tarek Abd El Maksoud, MBBCH

  Alexandria University

  STUDY CHAIR

• Marwa Essawy

  Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to the treatment allocation to reduce assessment bias during evaluation of scar improvement.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Model Details: Participants were assigned to one of four parallel treatment groups to compare the efficacy and safety of microneedling with 5-fluorouracil, intralesional 5-fluorouracil, intralesional corticosteroids, and Microneedling with normal saline as a control group in the treatment of hypertrophic scars and keloids

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 21, 2026
• Study Start: January 12, 2023
• Primary Completion: January 15, 2024
• Study Completion: March 8, 2025
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)