Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Onabotulinum Toxin Type A and Abobotulinum Toxin Type A Crow's Feet Rhytid Study

This study has been completed.
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Corey S. Maas, M.D., The Maas Clinic
ClinicalTrials.gov Identifier:
NCT01529788
First received: February 8, 2012
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

The objective of the study is to compare the time to onset of Dysport® versus Botox® in the treatment of lateral orbital rhytids ("crow's feet"). Thirty subjects were enrolled in the study; specifically 30 male or female patients 18 years or older with moderate to severe lateral orbital rhytids at maximum contracture. Each patient were randomized to be treated with Dysport® on one side and Botox® on the other side. Both the injector and patient were blinded to the injected toxin.

The efficacy endpoints were determined by investigator and subject live assessment of "crow's feet" at rest and maximum contraction at each visit (every other day for 6 days post-injection, every month for 9 months following) using a validated 5 point photographic scale(no wrinkles [0], very fine wrinkles [1], fine wrinkles [2], moderate wrinkles [3] or severe wrinkles [4]) used in previous studies. A written description of each photograph was included to help standardize the application of the Photographic Scale.


Condition Intervention Phase
Intrinsic Aging of Skin
Solar Elastosis
Drug: Right lateral orbital injection of Botox Cosmetic or Dysport
Drug: Left lateral orbital injection of Botox Cosmetic or Dysport
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blinded Randomized Controlled Trial to Compare the Efficacy, Time to Onset, and Duration of Two Botulinum Type A Exotoxins (Onabotulinum Toxin A and Abobotulinum Toxin A) in the Treatment of "Crow's Feet."

Resource links provided by NLM:


Further study details as provided by The Maas Clinic:

Primary Outcome Measures:
  • To compare the time to onset of action, efficacy and duration of Dysport® versus Botox® Cosmetic in the treatment of lateral orbital rhytids. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Subject and investigator assessed grading as well as subject preference


Secondary Outcome Measures:
  • To determine the safety and presence of any adverse effects of Dysport® (25 units) versus Botox® Cosmetic (10 units) in the treatment of lateral orbital rhytids. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: September 2009
Study Completion Date: September 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lateral orbital injection of Botox Cosmetic or Dysport
Lateral orbital injection of either Botox Cosmetic, 10 units or Dysport, 30 units as a single dose in a randomized (right or left sides) double blind fashion in 90 consecutive subjects
Drug: Right lateral orbital injection of Botox Cosmetic or Dysport
Right lateral orbital injection of Botox Cosmetic or Dysport (10 units and 30 units, respectively) divided among 4 injection points (0.05 mL [7.5 units] per injection point) divided among 4 injection points (0.05mL [2.5units]) on Day 0 of the study
Other Names:
  • Botox Cosmetic
  • Dysport
Drug: Left lateral orbital injection of Botox Cosmetic or Dysport
Left lateral orbital injection of Botox Cosmetic or Dysport (10 units and 30 units, respectively) divided among 4 injection points (0.05 mL [7.5 units] per injection point) divided among 4 injection points (0.05mL [2.5units]) on Day 0 of the study
Other Names:
  • Botox Cosmetic
  • Dysport

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Male or female patients who meet all of the following criteria are eligible for this study:

  • Eighteen years of age or older.
  • Moderate to severe lateral orbital rhytids at maximum smile (score of [2] or [3] by physician assessment)
  • Negative pregnancy test for females of childbearing potential.
  • Time and ability to complete the study and comply with instructions.
  • Understanding of the study and contents of the informed consent.

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for this study:

  • Previous treatment to the glabellar area, forehead or lateral orbital rhytids with Dysport® or Botox® Cosmetic or other botulinum toxin within 180 days of entry into the study. Botulinum toxin treatment of areas other than the lateral orbital rhytids at any time during the study.
  • Patients with an ongoing treatment-related AE from any Dysport® or Botox® Cosmetic or botulinum toxin study.
  • Inability to substantially lessen lateral orbital lines by physically spreading them apart.
  • Permanent or semi-permanent dermal fillers in the lateral orbital rhytids at any time.
  • Ablative skin resurfacing on the lateral orbital rhytids at any time preceding the study or planning to during the current study.
  • Upper eyelid blepharoplasty or brow lift at any time preceding the study or planning to during the current study.
  • Non-ablative treatments in the lateral orbital region for skin dyschromias (e.g. Intense Pulsed Light, light-emitting diodes) at any time during the current study.
  • Non-ablative dermal treatment in the lateral orbital area for skin tightening (e.g. radiofrequency treatments at any time preceding the current study or planned to have this done during the current study.
  • Retinoid, microdermabrasion, or prescription-level glycolic acid treatments to the lateral orbital area within 2 weeks prior to study participation or during the current study.
  • Concurrent therapy that, in the investigator's opinion, would interfere with evaluation of the efficacy or safety of the medication.
  • Active infection of the lateral orbital area (e.g. acute acne lesions or ulcers).
  • Pregnant women, nursing mothers, or women who are planning pregnancy during the study, or think they may be pregnant at the start of the study. Throughout the course of the study, women of childbearing potential must use reliable forms of contraception (e.g. abstinence, oral contraceptives for more than 12 consecutive weeks prior to enrollment, or spermicide and condoms).
  • Current history of chronic drug or alcohol abuse.
  • Enrollment in any active study involving the use of investigational devices or drugs.
  • Current facial palsy.
  • Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
  • Neuromuscular junctional disorders (myasthenia gravis).
  • Known allergy or hypersensitivity to any botulinum toxin or any component of Dysport® or Botox® Cosmetic.
  • Clinically diagnosed anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that, in the opinion of the investigator, might interfere with the patient's participation in the study.
  • Concurrent use of medications that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle, and aminoglycoside antibiotics.
  • Presence of any condition( e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function) or circumstance that, in the judgment of the investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529788

Locations
United States, California
The Maas Clinic
San Francisco, California, United States, 94115
Sponsors and Collaborators
The Maas Clinic
Medicis Pharmaceutical Corporation
Investigators
Principal Investigator: Corey S Maas, MD The Maas Clinic
  More Information

Publications:
Erian A, Ionescu NE. Combination treatment of glabellar rhytids. Int J Cosmetic Surg 1999;7(1):14-17.
McLarty JW, Levine RJ. How many subjects are required for a study? IRB 1987, 9:1-3.

Responsible Party: Corey S. Maas, M.D., Director, The Maas Clinic
ClinicalTrials.gov Identifier: NCT01529788     History of Changes
Other Study ID Numbers: Medicis-Crow 4
Study First Received: February 8, 2012
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The Maas Clinic:
abobotulinum toxin lateral orbital lines
BotoxCosmetic
Dysport
onabotulinum toxin
wrinkles
lateral orbital lines

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014