Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines (RADIANT)

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Revance Therapeutics

Status and phase

Completed
Phase 3

Conditions

Skin Aging

Treatments

Drug: Botulinum Toxin Type A
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01776606
RT001-CL019

Details and patient eligibility

About

This study will evaluate the efficacy and safety of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines.

Enrollment

247 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Moderate to severe crow's feet lines
  • Female or male, 18 to 65 years of age and in good general health
  • Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study

Exclusion criteria

  • Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A
  • Muscle weakness or paralysis, particularly in the area receiving study treatment
  • Active skin disease or irritation at the treatment area
  • Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
  • Treatment with botulinum toxin type A for crow's feet lines in the last 6 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

247 participants in 2 patient groups, including a placebo group

Dose A
Active Comparator group
Description:
Dose A: Botulinum toxin type A
Treatment:
Drug: Botulinum Toxin Type A
Dose B
Placebo Comparator group
Description:
Dose B: Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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