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

NCT01529788 | Completed Phase 4

• 1 other identifier: Medicis-Crow 4
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrinsic Aging of Skin; Solar Elastosis

Keywords

abobotulinum toxin lateral orbital lines; BotoxCosmetic; Dysport; onabotulinum toxin; wrinkles; lateral orbital lines

Outcome Measures

Primary Outcomes (1)

• To compare the time to onset of action, efficacy and duration of Dysport® versus Botox® Cosmetic in the treatment of lateral orbital rhytids.

  Subject and investigator assessed grading as well as subject preference

  9 months

Secondary Outcomes (1)

• 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.

  9 months

Study Arms (1)

Lateral orbital injection of Botox Cosmetic or Dysport

ACTIVE COMPARATOR

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; Drug: Left lateral orbital injection of Botox Cosmetic or Dysport

Interventions

Right lateral orbital injection of Botox Cosmetic or Dysport DRUG

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

Also known as: Botox Cosmetic, Dysport

Lateral orbital injection of Botox Cosmetic or Dysport

Left lateral orbital injection of Botox Cosmetic or Dysport DRUG

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

Also known as: Botox Cosmetic, Dysport

Lateral orbital injection of Botox Cosmetic or Dysport

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Maas Clinic: lead
• Medicis Pharmaceutical Corporation: collaborator

Study Sites (1)

The Maas Clinic

San Francisco, California, 94115, United States

Location

Related Publications (19)

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MeSH Terms

Interventions

abobotulinumtoxinA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Corey S Maas, MD

  The Maas Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 9, 2012
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2014
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

US (1)