A Multi-Center Study Of CD07743 for the Improvement of Lateral Canthal Lines (CROW'S FEET)

NCT ID: NCT01308060

Last Updated: 2020-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 335 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-05-31

Brief Summary

This double-blind study has two parts for each subject (same population):

Part A: initial treatment in Lateral Canthal Lines (LCL) (placebo-controlled):

• To assess the efficacy and safety of Azzalure® compared to placebo in the improvement of moderate to severe LCLs.
• To assess the subjects' level of satisfaction with the appearance of their LCLs compared to placebo.

Part B: repeated treatment in LCL with or without Glabellar Lines (GL) (active treatment, up to 1 year):

• To assess safety of Azzalure® following repeated administration in the improvement of moderate to severe LCLs.
• To assess the safety of Azzalure® when used concomitantly for improvement of moderate to severe LCLs and GLs.
• To assess the subjects' level of satisfaction with the appearance of their LCLs.

Conditions

Canthal Lines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Botulinum Toxin type A

During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.

Placebo

During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Botulinum Toxin Type A

During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female subjects, 18 to 65 years of age (Screening visit),
• Moderate or severe (grade 2 or 3, Hund 2006) Lateral Canthal Lines "at maximum smile" determined by investigator at screening and baseline
• Mild to severe (grade 1, 2 or 3, Hund 2006) Lateral Canthal Lines "at rest" determined by investigator at screening and baseline
• The subject is a female of childbearing potential and has a negative urine pregnancy test (UPT) at screening and baseline
• Subjects who are not satisfied with their appearance at screening and baseline
• The subject is willing and able to comply with the requirements of the protocol and agree to adhere to the visit schedule, concomitant therapy prohibitions and must be compliant to the study instruction.
• The subject agrees to participate in the study, verified by dating and signing an approved written Informed Consent Form (ICF) and Photography Consent Form (PCF) (selected sites only if applicable) at the enrolment visit before any study procedures at screening

Exclusion Criteria

• Any prior surgery affecting the orbicularis oculi muscle, prior blepharoplasty or brow lift, or any prior cosmetic procedures or scars that may interfere with the evaluation of the investigator.
• Previous insertion of any permanent, semi-permanent or biodegradable material in the periorbital region or facial treatment with augmentation material (e.g. silicon injections, collagen type implants, hyaluronic acid, lactic acid, etc.) within 12 months prior to screening.
• Any prior treatment with botulinum toxin (of any serotype)
• Previous treatment with lasers for skin resurfacing (e.g. CO2 (carbon dioxide)-laser) or treatment with deep chemical peels and any other esthetic or dermatologic treatments or procedures in any area of the face within 12 months prior to screening.
• Any planned facial cosmetic surgery or procedures during the study period.
• Presence of any bleeding disorders
• Pregnant or lactating women or women who are planning pregnancy during the study.
• Known hypersensitivity to any of the test materials or related compounds.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RD.03.SPR.40131

Identifier Type: -

Identifier Source: org_study_id