Botulinum Toxin Type a Injection to Prevent Keloid Recurrence

PHASE4CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

October 13, 2020

Primary Completion Date

March 20, 2024

Study Completion Date

March 20, 2024

Conditions
Scar Keloid
Interventions
DRUG

Botulinum Toxin Type A Injection [Botox]

After the whole surgical procedures of keloid revision are done, the participants will receive Botulinum Toxin type A (BTA) injection. The investigators split the scar into the right side and the left side. BTA and 0.9% saline, respectively, are used for the two arms of the study. Vials containing 100 units of BTA (BotoxⓇ, Allergan) are mixed with 2mL 0.9% injectable saline. The injection depth will be the intradermal layer. Injections will be performed with a 30-gauge needle and 1 mL syringe. Just before skin closure, the entire scar was treated, with sides randomized to receive treatment with either BTA or 0.9% normal saline. The dosage is 8 units / cm based on aforementioned studies. The maximal dose won't exceed 100 units.

DRUG

0.9% Sodium Chloride Injection

After the whole surgical procedures of keloid revision are done, the participants will receive 0.9% saline injection. The investigators split the scar into the right side and the left side. BTA and 0.9% saline, respectively, are used for the two arms of the study. Only 0.9% saline is injected on the control side. The injection depth will be the intradermal layer. Injections will be performed with a 30-gauge needle and 1 mL syringe. Just before skin closure, the entire scar was injected, with sides randomized to receive treatment with either BTA or 0.9% normal saline. The dosage is 0.16 mL / cm.

Trial Locations (1)

Unknown

National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan City

All Listed Sponsors
collaborator

Tainan Hospital, Ministry of Health and Welfare

OTHER

lead

National Cheng-Kung University Hospital

OTHER

NCT05072821 - Botulinum Toxin Type a Injection to Prevent Keloid Recurrence | Biotech Hunter | Biotech Hunter