Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines

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Allergan

Status and phase

Completed
Phase 4

Conditions

Glabellar Rhytides

Treatments

Biological: botulinum toxin Type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT01814670
AP-BTXC-12-001

Details and patient eligibility

About

A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated with facial laser resurfacing.

Enrollment

185 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • moderate or severe frown lines
  • facial laser treatment between 4 to 8 weeks prior to Day 1

Exclusion criteria

  • previous use of botulinum toxin for any indication
  • diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
  • microdermabrasion or superficial peels, permanent make-up to the brow and forehead area within the last 3 months
  • facial cosmetic procedures within the last 6 Months
  • treatment to forehead, brow, nose or midface areas with any filler within the last 12 months
  • use of a new topical skin care product within 1 month of the screening
  • any prior forehead or periorbital surgery or brow lift
  • deep dermal scarring, excessively thick sebaceous skin, and/ or loss of skin elasticity
  • any facial skin infection or unhealed skin lesion
  • pregnant or breast-feeding

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

185 participants in 1 patient group

botulinum toxin Type A
Experimental group
Description:
20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Treatment:
Biological: botulinum toxin Type A

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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