ClinicalTrials.Veeva

Menu

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

Allergan logo

Allergan

Status and phase

Completed
Phase 1

Conditions

Facial Fine Lines

Treatments

Drug: Botox
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04631588
1940-102-008

Details and patient eligibility

About

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

Enrollment

172 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

172 participants in 3 patient groups, including a placebo group

Open Label BOTOX
Experimental group
Description:
Participants will receive BOTOX at Baseline (Day 1)
Treatment:
Drug: Botox
Double-Blind Randomized BOTOX
Experimental group
Description:
Participants will receive BOTOX at Baseline (Day 1)
Treatment:
Drug: Botox
Double Blind Randomized Placebo
Placebo Comparator group
Description:
Participants will receive placebo at Baseline (Day 1)
Treatment:
Drug: Placebo

Trial contacts and locations

5

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems