Completed

NCT Number: NCT04631588

Intradermal (ID) BOTOX in the Treatment of 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.

Completed

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Key information

Conditions

Facial Fine Lines

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botox

Drug

Intradermal (ID) injection

Placebo

Drug

Intradermal (ID) injection

Primary outcomes

Number of Participants with Adverse Events (AEs)

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Baseline (Day 1)

Unique number of participants who experience injection site pain and/or discomfort at the injection site during administration of treatment.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Nov 17, 2020
Registry last updated: Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.