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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01308060
First received: March 2, 2011
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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

Part A: initial treatment in CL (placebo-controlled):

  • To assess the efficacy, safety and duration of effect of Azzalure® compared to placebo in the improvement of moderate to severe Lateral Canthal Lines.
  • To assess the subjects' level of satisfaction with the appearance their Lateral Canthal Lines compared to placebo.

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

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

Condition Intervention Phase
Canthal Lines
Drug: Botulinum Toxin Type A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A MULTI-CENTER RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP STUDY OF CD07743 FOR THE IMPROVEMENT OF LATERAL CANTHAL LINES (CROW'S FEET)

Resource links provided by NLM:


Further study details as provided by Galderma R&D:

Primary Outcome Measures:
  • Primary efficacy criteria [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The primary criterion for efficacy is the proportion of responders at Week 4 on the severity of Lateral CL "at maximum smile". A positive response (responder) is defined as a grade of 0 or 1 (none or mild), as assessed by the investigator.


Secondary Outcome Measures:
  • Secondary efficacy criteria [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Number and proportion of subjects with each satisfaction grading for the appearance of his/her Lateral Canthal Lines at all Timepoints


Enrollment: 335
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum Toxin type A
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
Drug: Botulinum Toxin Type A
During part A, Azzalure will be adminitered at Baseline 60 Spey unit at canthal lines and compared with placebo.
Placebo Comparator: Placebo
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
Drug: Botulinum Toxin Type A
During part A, Azzalure will be adminitered at Baseline 60 Spey unit at canthal lines and compared with placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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-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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01308060     History of Changes
Other Study ID Numbers: RD.03.SPR.40131
Study First Received: March 2, 2011
Last Updated: August 6, 2012
Health Authority: Germany: BfArM
France: AFSSAPS
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Galderma R&D:
Canthal lines

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014