Facial FlushingPhase 4NCT02216838
Treatment of Facial Flushing With Botulinum Toxin A Injections
A Phase 4 study testing botulinum toxin A in people with Facial Flushing, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to find out if botulinum toxin A (botox®) can be used to treat facial flushing. This study is a pilot study designed to determine feasibility of these procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Flushing
- What is being tested?
- botulinum toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Patients 18-65 years of age with persistent facial flushing
- Willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the study staff.
Who cannot join
- Unable to understand the protocol or give informed consent
- Younger than 18 or older than 65 years of age
- Females who are pregnant or lactating
- Known hypersensitivity to BTX-A
- Subjects using medications that interfere with neuromuscular functions (such as aminoglycoside antibiotics)
- Subjects who have a history of congestive heart failure, carcinoid syndrome, mastocystosis, or renal cell carcinoma
Show all 21Show fewer
- Botulinum toxin injections in the past 6 months
- Ablative laser procedure in the past 6 months
- Radiofrequency device treatment in the past 6 months
- Ultrasound device treatment in the past 6 months
- Medium to deep chemical peel in the past 6 months
- Temporary soft tissue augmentation material in the area to be treated in the past year
- Semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
- Permanent soft tissue augmentation material in the area to be treated
- Is planning to receive within the next 6 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region.
- Is planning to use tretinoin or retinoic acid in the next 6 months
- Has an active infection in the forehead or glabellar region (excluding mild acne)
- Is allergic to cow's milk protein
- Is allergic to albumin
- Is currently using anticoagulation therapy
- Has a history of bleeding disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Treatment of Facial Flushing With Botulinum Toxin A Injections: A Split-Face, Double-blinded, Randomized Control Trial
The purpose of this study is to find out if botulinum toxin A (botox®) can be used to treat facial flushing.
This study is a pilot study designed to determine feasibility of these procedures.
- Conditions
- Facial Flushing
- Being tested
- botulinum toxin A, Saline Control
- Medical subject headings
- Blushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin ADrug
Also called Botox
A total of 10U will be injected at 1cm increments by the blinded dermatologist into the respective randomized side.
Saline ControlOther
A total of 0.5cc benzyl alcohol containing saline will be injected at 1cm increments by the blinded dermatologist into the respective randomized side
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin A | Experimental | This study is randomized, which means the subject will be randomly assigned (like a flip of a coin) to receive botox on the right or left side of the face and saline injections on the other side. Only one side of the face will receive botox injections. Receives: Drug: botulinum toxin A |
| Saline Control | Placebo comparator | This study is randomized, which means the subject will be randomly assigned (like a flip of a coin) to receive botox on the right or left side of the face and saline injections on the other side. Only one side of the face will receive botox injections. Receives: Other: Saline Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectrophotometer measurement
Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial FlushingStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216838
- Sponsor's protocol ID
- STU97514
- Status last verified
- Jun 2026
- First submitted
- 12 Aug 2014
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Facial Flushing With Botulinum Toxin A Injections: A Split-Face, Double-blinded, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02216838
- Acronym / sponsor ID
- STU97514
- Conditions
- Facial Flushing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Aug 2014 (estimated)
- 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 purpose of this study is to find out if botulinum toxin A (botox®) can be used to treat facial flushing.
This study is a pilot study designed to determine feasibility of these procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin A | Experimental | Drug: botulinum toxin AThis study is randomized, which means the subject will be randomly assigned (like a flip of a coin) to receive botox on the right or left side of the face and saline injections on the other side. Only one side of the face will receive botox injections. |
| Saline Control | Placebo comparator | Other: Saline ControlThis study is randomized, which means the subject will be randomly assigned (like a flip of a coin) to receive botox on the right or left side of the face and saline injections on the other side. Only one side of the face will receive botox injections. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18-65 years of age with persistent facial flushing
- Willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the study staff.
Key exclusion criteria (21 listed)
- Unable to understand the protocol or give informed consent
- Younger than 18 or older than 65 years of age
- Females who are pregnant or lactating
- Known hypersensitivity to BTX-A
- Subjects using medications that interfere with neuromuscular functions (such as aminoglycoside antibiotics)
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 |
|---|---|---|
| botulinum toxin AAlso: BotoxA total of 10U will be injected at 1cm increments by the blinded dermatologist into the respective randomized side. | Drug | botulinum toxin A |
| Saline ControlA total of 0.5cc benzyl alcohol containing saline will be injected at 1cm increments by the blinded dermatologist into the respective randomized side | Other | Saline Control |
Primary outcome
Spectrophotometer measurement
Time frame: Baseline and 8 weeks
Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing botulinum toxin A in people with Facial Flushing, run by Northwestern University at 1 site 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 2 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Spectrophotometer measurement (time frame: Baseline and 8 weeks). 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 1 Jul 2026.