A Study Comparing the Safety, Efficacy, and Diffusion of Letibotulinum Toxin A Versus Other Botulinum Toxin Products in Adults With Moderate-to-Severe Forehead Wrinkles

PHASE4CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 14, 2022

Primary Completion Date

August 26, 2022

Study Completion Date

September 7, 2022

Conditions
Forehead Rhytides
Interventions
DRUG

Letibotulinum toxin A

Letibotulinum toxin A (Botulax) is a botulinum toxin type A formulation developed for aesthetic indications. In this trial, it was administered as the test intervention. Each participant received 2 units injected at four forehead sites (total 8 units), diluted to 20 U/mL, on one side of the forehead. The diffusion characteristics and efficacy were compared with those of onabotulinum and prabotulinum toxin A in a double-blind, randomized, split-face design.

DRUG

Prabotulinum toxin A

Prabotulinum toxin A (Nabota) is a botulinum toxin type A product approved for aesthetic use in South Korea and other countries. It was used as a comparator agent in this trial. Participants received subcutaneous injections at four forehead sites (2 units per site, 8 units total), diluted to 20 U/mL, on one side of the forehead in a randomized, split-face design.

DRUG

Onabotulinum toxin A

Onabotulinum toxin A (Botox) is an FDA-approved botulinum neurotoxin type A formulation used for cosmetic treatment of glabellar lines and other facial wrinkles. In this study, it was injected subcutaneously into the forehead at four standardized sites at a dose of 2 units per site (8 units total), diluted to 20 U/mL, and used as a comparator in the split-face design.

Trial Locations (1)

03722

Severance Hospital, Yonsei University College of Medicine, Seoul

All Listed Sponsors
collaborator

Korea International Cooperation Agency (KOICA)

UNKNOWN

lead

Yonsei University

OTHER