Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines

NCT03408236 — Phase 3, Completed, 240 participants, Hugel

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Randomized, Double-blind, Active-controlled, Multicenter, Phase I/III Clinical Trial to Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines

Registry	NCT03408236
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	240 (Actual)
Sponsor	Hugel (Industry)
Conditions	Crow's Feet Lines
Interventions	Botulinum toxin type A (Drug)
Dates	start 2018-01-17, primary completion 2018-12-13, completion 2019-06-07, first posted 2018-01-23, last updated 2022-04-15
Locations	1 site in South Korea

-Summary

To determine the efficacy and safety of Botulax® in treatment of crow's feet line

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+Detailed description

1. Allocation: Randomized
2. Masking: Double Blind

+Arms and interventions

Arm	Type	Interventions	Description
Botulax	Experimental	Drug: Botulinum toxin type A	Single dose
Botox	Active comparator	Drug: Botulinum toxin type A	Single dose

Botulinum toxin type A (Drug), also known as Botulax: Experimental
Botulinum toxin type A (Drug), also known as Botox: Active Comparator

+Outcome measures

Primary outcomes

Facial Wrinkle Scale(FWS) severity of crow's feet lines(CFL) at maxium smile as assessed by investigators [4weeks]: The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported as assessed by investigators

+Eligibility

Sex: All, ages: 19 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* Male or female of at least 19 to 65 years old
* Bilaterally symmetrical moderator-to-severe CFL at maximum smile on the FWS as rated by the investigator

Exclusion Criteria:

* Subject with hypersensitivity to the investigational products or their components
* Female subject who are pregnant or lactating
* Subject who are unable to communicate or follow the instructions
* Subject who are not eligible for this study based on the judgment of an investigator

+Locations (1)

Facility	City	Country	Status
Hugel	Seoul	South Korea

+Publications

Results publication: Yoo KH, Park SJ, Han HS, Won CH, Lee YW, Kim BJ. Randomized, double-blind, active-controlled, multicentre, phase III clinical trial with two stages to assess the safety and efficacy of letibotulinum toxin a vs. onabotulinum toxin a for subjects with moderate to severe crow's feet. J Eur Acad Dermatol Venereol. 2021 Jul;35(7):1587-1594. doi: 10.1111/jdv.17217. Epub 2021 Apr 12. PMID 33721365

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