BOTOX® for the Treatment of Platysma Prominence

Allergan

Status and phase: Completed; Phase 2

Conditions: Platysma Prominence

Treatments: Drug: BOTOX® purified neurotoxin complex; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03915067

1936-201-008

Details and patient eligibility

About

To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period

• A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies:

  1. Not a woman of childbearing potential (WOCBP) OR
  2. A WOCBP who agrees to follow the studies contraceptive guidance during the treatment and follow-up period through study exit.

• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this study's protocol

Exclusion criteria

• Any medical condition that may put the participant at increased medical risk with exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
• Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
• Anticipated need for surgery or overnight hospitalization during the study
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
• Females who are pregnant, nursing, or planning a pregnancy during the study
• Known immunization or hypersensitivity to any botulinum toxin serotype
• History of alcohol or drug abuse within 12 months of the study
• Participant has tattoos, jewelry, or clothing that cannot be removed, and that obscure the neck

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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171 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.

Treatment:

Drug: Placebo

BOTOX® Low Dose

Experimental group

Description:

Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.

Treatment:

Drug: BOTOX® purified neurotoxin complex

BOTOX® High Dose

Active Comparator group

Description:

Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.

Treatment:

Drug: BOTOX® purified neurotoxin complex