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

NCT04631588 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 1940-102-008
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Facial Fine Lines

Keywords

Facial Fine Lines,BOTOX,Onabotulinum Toxin A

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (3)

Open Label BOTOX

EXPERIMENTAL

Participants will receive BOTOX at Baseline (Day 1)

Drug: Botox

Double-Blind Randomized BOTOX

EXPERIMENTAL

Participants will receive BOTOX at Baseline (Day 1)

Drug: Botox

Double Blind Randomized Placebo

PLACEBO COMPARATOR

Participants will receive placebo at Baseline (Day 1)

Drug: Placebo

Interventions

Botox DRUG

Intradermal (ID) injection

Double-Blind Randomized BOTOX; Open Label BOTOX

Placebo DRUG

Intradermal (ID) injection

Double Blind Randomized Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (5)

Skin and Cancer Associates, LLP /ID# 225152

Miami, Florida, 33137-3254, United States

Location

Laser & Skin Surgery Center of New York /ID# 225153

New York, New York, 10016-4974, United States

Location

Tennessee Clinical Research Center /ID# 225151

Nashville, Tennessee, 37215-2885, United States

Location

Austin Institute for Clinical Research /ID# 225154

Pflugerville, Texas, 78660, United States

Location

Advanced Clinical Research /ID# 225155

Salt Lake City, Utah, 84101-1345, United States

Location

Related 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.

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 17, 2020
• Study Start: November 16, 2020
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)