Facial Fine LinesPhase 1NCT04631588
Intradermal (ID) BOTOX in the Treatment of Facial Fine Lines
A Phase 1 study testing Botox in people with Facial Fine Lines, run by Allergan at 5 sites in United States.
Trial summary
The main objective of this study is to assess safety and tolerability of Intradermal (ID) BOTOX in participants with facial fine lines. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Fine Lines
- What is being tested?
- Botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Nov 2020to 3 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Skin and Cancer Associates, LLP /ID# 225152
Miami, Florida, 33137-3254
Tennessee Clinical Research Center /ID# 225151
Nashville, Tennessee, 37215-2885
Laser & Skin Surgery Center of New York /ID# 225153
New York, New York, 10016-4974
Austin Institute for Clinical Research /ID# 225154
Pflugerville, Texas, 78660
Advanced Clinical Research /ID# 225155
Salt Lake City, Utah, 84101-1345
About this study
Official title: 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.
- Conditions
- Facial Fine Lines
- Being tested
- Botox, Placebo
- Keywords
- Facial Fine Lines,BOTOX,Onabotulinum Toxin A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxDrug
Intradermal (ID) injection
PlaceboDrug
Intradermal (ID) injection
| Study group | Role | What they receive |
|---|---|---|
| Open Label BOTOX | Experimental | Participants will receive BOTOX at Baseline (Day 1) Receives: Drug: Botox |
| Double-Blind Randomized BOTOX | Experimental | Participants will receive BOTOX at Baseline (Day 1) Receives: Drug: Botox |
| Double Blind Randomized Placebo | Placebo comparator | Participants will receive placebo at Baseline (Day 1) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
Unique number of participants who experience one or more treatment emergent adverse event
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start16 Nov 2020
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Fine LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631588
- Sponsor's protocol ID
- 1940-102-008
- Status last verified
- Nov 2021
- First submitted
- 13 Nov 2020
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Safety and Tolerability of Intradermal BOTOX® (OnabotulinumtoxinA) Purified Neurotoxin Complex in Participants With Facial Fine Lines
- ClinicalTrials.gov ID
- NCT04631588
- Acronym / sponsor ID
- 1940-102-008
- Conditions
- Facial Fine Lines
- Keywords
- Facial Fine Lines,BOTOX,Onabotulinum Toxin A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to assess safety and tolerability of Intradermal (ID) BOTOX in participants with facial fine lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Label BOTOX | Experimental | Drug: BotoxParticipants will receive BOTOX at Baseline (Day 1) |
| Double-Blind Randomized BOTOX | Experimental | Drug: BotoxParticipants will receive BOTOX at Baseline (Day 1) |
| Double Blind Randomized Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo at Baseline (Day 1) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BotoxIntradermal (ID) injection | Drug | Double-Blind Randomized BOTOX, Open Label BOTOX |
| PlaceboIntradermal (ID) injection | Drug | Double Blind Randomized Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALLERGAN INC. study director
Allergan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Botox in people with Facial Fine Lines, run by Allergan at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: Baseline (Day 1) to Final Visit (up to Day 97)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.