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NOT YET RECRUITING
NCT06230146
PHASE1/PHASE2

Efficacy and Safety of Fractional CO2 Laser Combined With Intralesional Insulin, Botulinum Toxin or Triamcinolone Acetonide in the Treatment of Keloid: A Clinical, Dermoscopic and Immunohistochemical Study.

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

Keloids are macroscopic cutaneous scarring that result from disturbance of wound healing, that occurs on predisposed individuals . Keloid shows a kind of over-healing, producing over abundant wound matrix responsible for raised, inflexible red scar tissue, that causes pain and itching .

Key Details

Gender

All

Age Range

10 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2024-05-01

Completion Date

2026-05-01

Last Updated

2024-01-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

Insulin group

Fractional ablative laser followed by Intralesional insulin injection (Human actrapid insulin 100 IU\\ml solution). Dose: injection of 0.1 ml\\cm3 of the lesion avoiding subcutaneous injection as much as possible especially in fatty areas.

DRUG

Botulinum toxin group

Fractional ablative laser followed by intralesional Botox-A (100 U vacuum-dried powder in a single-use vial for reconstitution diluted in 2 mL of sterile, preservative-free 0.9% saline to constitute a solution at a concentration of 5 U/0.1 mL),It will be injected into the body of the keloid with the help of a 24gauge needle at a distance of 1 cm apart until slight blanching is visible. The dose will be adjusted to 2.5 U/cm3 of the lesion, not exceeding 100 units per session.

DRUG

Triamcinolone acetonide group

Fractional ablative laser followed by Triamcinolone acetonide injection. TAC 40 mg/ml will be diluted with normal saline solution 0.9% to the concentration of 20 mg/ml .Maximum drug injected during each session will be 40 mg triamcinolone.

Locations (1)

Assiut University

Asyut, Egypt