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

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

Official Title
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Phase 1b Safety and Tolerability of Intradermal BOTOX® (OnabotulinumtoxinA) Purified Neurotoxin Complex in Participants With Facial Fine Lines

Conditions
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Facial Fine Lines

Intervention / Treatment
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* Drug: Botox
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label BOTOX<br>Participants will receive BOTOX at Baseline (Day 1) | Drug: Botox<br>* Intradermal (ID) injection<br>|
| Experimental: Double-Blind Randomized BOTOX<br>Participants will receive BOTOX at Baseline (Day 1) | Drug: Botox<br>* Intradermal (ID) injection<br>|
| Placebo Comparator: Double Blind Randomized Placebo<br>Participants will receive placebo at Baseline (Day 1) | Drug: Placebo<br>* Intradermal (ID) injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) | Unique number of participants who experience one or more treatment emergent adverse event | Baseline (Day 1) to Final Visit (up to Day 97) | 
| Number of Participants with Potential Clinically Significant (PCS) changes in vital signs | Unique number of participants who experience one or more Potential Clinically Significant (PCS) change in vital signs from the Baseline visit. | Baseline (Day 1) to Final Visit (up to Day 97) | 
| Number of Participants with Potential Clinically Significant (PCS) changes in physical exams | Unique number of participants who experience one or more Potential Clinically Significant (PCS) change in physical exams from the Baseline visit. | Baseline (Day 1) to Final Visit (up to Day 97) | 
| Number of Participants with injection site pain/discomfort. | Unique number of participants who experience injection site pain and/or discomfort at the injection site during administration of treatment. | Baseline (Day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facial Fine Lines,BOTOX,Onabotulinum Toxin A