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

Phase 1

Completed

• Conditions: Facial Fine Lines
• Interventions: Drug: Placebo; Drug: Botox

• Registration Number: NCT04631588
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-13
• Study Start: 2020-11-16
• Study First Posted: 2020-11-17
• Status Verified: 2021-11
• Primary Completion: 2021-11-03
• Study Completion: 2021-11-03
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double Blind Randomized Placebo	Placebo	Participants will receive placebo at Baseline (Day 1)
Open Label BOTOX	Botox	Participants will receive BOTOX at Baseline (Day 1)
Double-Blind Randomized BOTOX	Botox	Participants will receive BOTOX at Baseline (Day 1)

Primary Outcome Measures

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

Trial Locations

Locations (5)

Skin and Cancer Associates, LLP /ID# 225152; 🇺🇸 Miami, Florida, United States

Advanced Clinical Research /ID# 225155; 🇺🇸 Salt Lake City, Utah, United States

Austin Institute for Clinical Research /ID# 225154; 🇺🇸 Pflugerville, Texas, United States

Laser & Skin Surgery Center of New York /ID# 225153; 🇺🇸 New York, New York, United States

Tennessee Clinical Research Center /ID# 225151; 🇺🇸 Nashville, Tennessee, United States