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Evaluation of the Effect of Lipid Nanoparticles Containing 5-Fluorouracil and Triamcinolone acetonide on the Treatment of Hypertrophic Scars

Evaluating the Efficacy of a Polymeric Film Containing Lipid Nanoparticles Loaded with 5-Fluorouracil and Triamcinolone acetonide in the Treatment of Hypertrophic Scars

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250417065368N1
Enrollment
10
Registered
2025-04-29
Start date
2025-05-05
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic scar. Hypertrophic scar

Interventions

Intervention 1: Intervention group: In this group of scar lesions, polymeric films containing lipid-based nanoparticles loaded with the two drugs 5-fluorouracil and triamcinolone acetonide will be use

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 60 Years

Inclusion criteria

Inclusion criteria: Individuals with at least one hypertrophic scar lesion ranging in size from 0.5 cm to 10 cm

Exclusion criteria

Exclusion criteria: Individuals with systemic diseases Individuals allergic to corticosteroids Pregnant women Individuals with neuropsychiatric disorders who are unable to tolerate maintaining a skin patch for 2 days

Design outcomes

Primary

MeasureTime frame
Measurement of hypertrophic scar height. Timepoint: Seven days after the initiation of using the nanoparticle-containing film. Method of measurement: Ruler.;Measurement of hypertrophic scar vascularity. Timepoint: Seven days after the initiation of using the nanoparticle-containing film. Method of measurement: Visual assessment.;Measurement of hypertrophic scar pliability. Timepoint: Seven days after the initiation of using the nanoparticle-containing film. Method of measurement: Palpation.;Assessment of hypertrophic scar pigmentation. Timepoint: Seven days after the initiation of using the nanoparticle-containing film. Method of measurement: Visual assessment.

Secondary

MeasureTime frame
Evaluation of changes in pruritus at the site of hypertrophic scar lesions. Timepoint: Even days after the initiation of using the nanoparticle-containing film. Method of measurement: Patient-reported outcomes.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Zakeri-Milani

Tabriz University of Medical Sciences

parvinzm@gmail.com+98 41 3334 8801

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026