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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03408236
Other study ID # HG-BOTCFL-III1
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 17, 2018
Est. completion date June 7, 2019

Study information

Verified date April 2022
Source Hugel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

1. Allocation: Randomized 2. Masking: Double Blind


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date June 7, 2019
Est. primary completion date December 13, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Botulinum toxin type A
Experimental
Botulinum toxin type A
Active Comparator

Locations

Country Name City State
Korea, Republic of Hugel Seoul

Sponsors (1)

Lead Sponsor Collaborator
Hugel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Facial Wrinkle Scale(FWS) severity of crow's feet lines(CFL) at maxium smile as assessed by investigators 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 4weeks
See also
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Completed NCT02195687 - BOTOX® in the Treatment of Crow's Feet Lines in China Phase 3
Completed NCT01189760 - Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines Phase 3
Completed NCT01189747 - Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines Phase 3
Recruiting NCT04081402 - A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines Phase 3
Completed NCT01224015 - Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines Phase 3
Completed NCT02176356 - Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study) Phase 4
Not yet recruiting NCT06402058 - A Study Comparing DMSB01 and Rejuran® for Temporary Crow's Feet Lines Improvement N/A
Completed NCT06376838 - To Prove the Non-inferiority of DLMR01 by Evaluating the Injecting Efficacy and Safety DLMR01 and Control for Patients in Crow's Feet N/A
Not yet recruiting NCT03184363 - Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines(Extension Study) Phase 3
Completed NCT01797081 - BOTOX® in the Treatment of Crow's Feet Lines in Japan Phase 3
Completed NCT01797094 - BOTOX® in the Treatment of Upper Facial Lines in Japan Phase 3
Completed NCT03317574 - MEDITOXIN® in Treatment of Crow's Feet Line Phase 3