Hypertrophic Scar, Keloid Scars
Conditions
Keywords
keloid, Hypertrophic scars, Microneedling, 5-Fluorouracil, Corticosteroids
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.
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.
Interventions
PROCEDUREMicroneedling with 5-Fluorouracil
Undiluted 5-FU was applied topically after microneedling
undiluted 5-fluorouracil was applied topically
Triamcinolone acetonide was administered intralesionally
PROCEDUREMicroneedling With saline
saline was applied after microneedling
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will be blinded to the treatment allocation to reduce assessment bias during evaluation of scar improvement.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients diagnosed with HTSs or keloids
Exclusion criteria
* pregnant or lactating females, immunocompromised patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vancouver Scar Scale | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient's satisfaction score | 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 |
| visual analogue scale | 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 |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORShaimaa Ismail Omar, MD
Alexandria University
STUDY_DIRECTORYehia Farouk Al-Jarem, MD
Alexandria University
STUDY_CHAIRAlaa Tarek Abd El Maksoud, MBBCH
Alexandria University
STUDY_CHAIRMarwa Essawy
Alexandria University
Outcome results
None listed