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.

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

January 1, 2026

Study Completion Date

May 1, 2026

Conditions
Keloid
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.

Trial Locations (1)

Unknown

Assiut University, Asyut

All Listed Sponsors
lead

Assiut University

OTHER

NCT06230146 - 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. | Biotech Hunter | Biotech Hunter