Intradermal (ID) BOTOX in the Treatment of Facial Fine Lines

Allergan

Status and phase: Completed; Phase 1

Conditions: Facial Fine Lines

Treatments: Drug: Botox; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04631588

1940-102-008

Details and patient eligibility

About

The main objective of this study is to assess safety and tolerability of Intradermal (ID) BOTOX in participants with facial fine lines.

Enrollment: 172 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A female participant must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study (eg, for at least 90 days after receiving study intervention).
• Participant must have sufficient visual acuity without the use of eyeglasses (contact lans use acceptable) to accurately assess their facial lines, in the opinion of the investigator.
• Participant must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active COVID-19 infection.
• Be nonsmoking and a nonuser of cannabis and nicotine-containing products, or have not smoked or used cannabis or nicotine-containing products, including e-cigarettes, within the previous 2 years.

Exclusion criteria

• Known immunization or hypersensitivity to any botulinum toxin serotype.
• 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.
• Rosacea, skin infection, or any other skin disease or disorder that would represent a safety concern and/or interfere with the ability to either administer treatment or assess the treatment effect, as determined by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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172 participants in 3 patient groups, including a placebo group

Open Label BOTOX

Experimental group

Description:

Participants will receive BOTOX at Baseline (Day 1)

Treatment:

Drug: Botox

Double-Blind Randomized BOTOX

Experimental group

Description:

Participants will receive BOTOX at Baseline (Day 1)

Treatment:

Drug: Botox

Double Blind Randomized Placebo

Placebo Comparator group

Description:

Participants will receive placebo at Baseline (Day 1)

Treatment:

Drug: Placebo