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

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

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

Study Overview

• Status: Completed
• Conditions: Facial Fine Lines
• Intervention / Treatment: Drug: Botox; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33137-3254
      • Skin and Cancer Associates, LLP /ID# 225152
  • New York
    • New York, New York, United States, 10016-4974
      • Laser & Skin Surgery Center of New York /ID# 225153
  • Tennessee
    • Nashville, Tennessee, United States, 37215-2885
      • Tennessee Clinical Research Center /ID# 225151
  • Texas
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research /ID# 225154
  • Utah
    • Salt Lake City, Utah, United States, 84101-1345
      • Advanced Clinical Research /ID# 225155

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Open Label BOTOX; Participants will receive BOTOX at Baseline (Day 1)	Drug: Botox; Intradermal (ID) injection
EXPERIMENTAL: Double-Blind Randomized BOTOX; Participants will receive BOTOX at Baseline (Day 1)	Drug: Botox; Intradermal (ID) injection
PLACEBO_COMPARATOR: Double Blind Randomized Placebo; Participants will receive placebo at Baseline (Day 1)	Drug: Placebo; Intradermal (ID) injection

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

Helpful Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com.,To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2020
• Primary Completion (ACTUAL): November 3, 2021
• Study Completion (ACTUAL): November 3, 2021

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (ACTUAL): November 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Facial Fine Lines,BOTOX,Onabotulinum Toxin A
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: 1940-102-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes