Keloid ScarsPhase 4MISTNCT07718269
Microneedling vs. 5-Fluorouracil or Steroid Injections for Hypertrophic Scars and Keloids
A Phase 4 study testing Microneedling with 5-Fluorouracil, Intralesional 5-fluorouracil and Intralesional Triamcinolone Acetonide in people with Keloid Scars and Hypertrophic Scar, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid Scars, Hypertrophic Scar
- What is being tested?
- Microneedling with 5-Fluorouracil, Intralesional 5-fluorouracil and Intralesional Triamcinolone Acetonide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2023to 8 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with HTSs or keloids
Who cannot join
- pregnant or lactating females, immunocompromised patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Keloid Scars, Hypertrophic Scar
- Being tested
- Microneedling with 5-Fluorouracil, Intralesional 5-fluorouracil, Intralesional Triamcinolone Acetonide, Microneedling With saline
- Keywords
- keloid, Hypertrophic scars, Microneedling, 5-Fluorouracil, Corticosteroids
- Medical subject headings
- Keloid, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedling with 5-FluorouracilProcedure or surgery
Undiluted 5-FU was applied topically after microneedling
Intralesional 5-fluorouracilDrug
undiluted 5-fluorouracil was applied topically
Intralesional Triamcinolone AcetonideDrug
Triamcinolone acetonide was administered intralesionally
Microneedling With salineProcedure or surgery
saline was applied after microneedling
| Study group | Role | What they receive |
|---|---|---|
| Microneedling with 5-Fluorouracil | Active comparator | Intervention Name: Microneedling With 5 Fluorouracil Intervention Type: Procedure Receives: Procedure: Microneedling with 5-Fluorouracil |
| Intralesional 5-Fluorouracil | Active comparator | Intervention name: Intralesional 5-Fluorouracil Intervention Type: drug Receives: Drug: Intralesional 5-fluorouracil |
| Intralesional Corticosteroids | Active comparator | Intervention name: Intralesional Triamcinolone Acetonide Intervention type: drug Receives: Drug: Intralesional Triamcinolone Acetonide |
| Microneedling with normal saline | Placebo comparator | Intervention name: Microneedling with normal saline Intervention type: Procedure Receives: Procedure: Microneedling With saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 weeks
Secondary outcomes (2)
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
Measured: 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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start12 Jan 2023
- Primary completion15 Jan 2024
- Study completion8 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keloid ScarsStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Ismail Abdelhamid, Alexandria University
- Investigators
- Shaimaa Ismail Omar, MD, Principal investigator, Alexandria UniversityYehia Farouk Al-Jarem, MD, Study director, Alexandria UniversityAlaa Tarek Abd El Maksoud, MBBCH, Study chair, Alexandria UniversityMarwa Essawy, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718269
- Sponsor's protocol ID
- 0107751
- Other IDs
- 00012098
- Acronym
- MIST
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: PD will not be shared due to participant confidentiality and ethical considerations
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling With 5-Fluorouracil Versus Intralesional 5-Fluorouracil or Corticosteroids for Hypertrophic Scars and Keloids
- ClinicalTrials.gov ID
- NCT07718269
- Acronym / sponsor ID
- MIST / 0107751
- Conditions
- Keloid Scars, Hypertrophic Scar
- Keywords
- keloid, Hypertrophic scars, Microneedling, 5-Fluorouracil, Corticosteroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 8 Mar 2025 (actual)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Microneedling with 5-Fluorouracil | Active comparator | Procedure: Microneedling with 5-FluorouracilIntervention Name: Microneedling With 5 Fluorouracil Intervention Type: Procedure |
| Intralesional 5-Fluorouracil | Active comparator | Drug: Intralesional 5-fluorouracilIntervention name: Intralesional 5-Fluorouracil Intervention Type: drug |
| Intralesional Corticosteroids | Active comparator | Drug: Intralesional Triamcinolone AcetonideIntervention name: Intralesional Triamcinolone Acetonide Intervention type: drug |
| Microneedling with normal saline | Placebo comparator | Procedure: Microneedling With salineIntervention name: Microneedling with normal saline Intervention type: Procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with HTSs or keloids
Key exclusion criteria (1 listed)
- pregnant or lactating females, immunocompromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microneedling with 5-FluorouracilUndiluted 5-FU was applied topically after microneedling | Procedure or surgery | Microneedling with 5-Fluorouracil |
| Intralesional 5-fluorouracilundiluted 5-fluorouracil was applied topically | Drug | Intralesional 5-Fluorouracil |
| Intralesional Triamcinolone AcetonideTriamcinolone acetonide was administered intralesionally | Drug | Intralesional Corticosteroids |
| Microneedling With salinesaline was applied after microneedling | Procedure or surgery | Microneedling with normal saline |
Primary outcome
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.
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.
2 secondary outcomes
Patient's satisfaction score
Time frame: 3 weeks
visual analogue scale
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. PD will not be shared due to participant confidentiality and ethical considerations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaimaa Ismail Omar, MD principal investigator
Alexandria University
Yehia Farouk Al-Jarem, MD study director
Alexandria University
Alaa Tarek Abd El Maksoud, MBBCH study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Microneedling with 5-Fluorouracil, Intralesional 5-fluorouracil and Intralesional Triamcinolone Acetonide in people with Keloid Scars and Hypertrophic Scar, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Scar Scale (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.