Forehead Rhytid ComplexPhase 4NCT01688076
Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection
A Phase 4 study testing Botulinum Toxin A in people with Forehead Rhytid Complex and Glabellar Rhytid Complex, run by Northwestern University at 1 site in United States.
Trial summary
This cross-over design study will evaluate the onset of action, efficacy, and duration of botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without subsequent muscle contraction. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Forehead Rhytid Complex, Glabellar Rhytid Complex
- What is being tested?
- Botulinum Toxin A
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 1 Mar 2022
- Phase
- Phase 4
- 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
- In good health
- Is 18-65 years of age
- Has static and dynamic forehead/glabellar wrinkles
- Has decided to receive Botox® treatment for their forehead/glabellar wrinkles
- Has the willingness and ability to understand and provide informed consent and communicate with the investigator
- Is willing to return for follow-up visits
Who cannot join
- Pregnant or lactating
- Has received the following treatments in the forehead or glabellar region:
- 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
Show all 21Show fewer
- medium to deep chemical peel in the past 6 months
- temporary soft tissue augmentation material in the past year
- semi-permanent soft tissue augmentation material in the past 2 years
- permanent soft tissue augmentation material
- Is planning to receive within the next year, 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 year
- Has an active infection in the forehead or glabellar region (excluding mild acne)
- Is allergic to cow's-milk protein
- Is allergic to albumin
- Taking aminoglycoside
- Is currently using anticoagulation therapy
- Has a history of bleeding disorders
- Is unable to understand the protocol or to give informed consent
- Is unable to return for follow-up visits
- Has a mental illness
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 Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection: Impact of Muscle Contraction on Onset of Action, Efficacy, and Duration of Treatment
This cross-over design study will evaluate the onset of action, efficacy, and duration of botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without subsequent muscle contraction.
Read the detailed description
In this cross-over design study, the investigators will evaluate whether active muscle contraction following Botox® injection of the forehead/glabellar rhytid complex will impact the onset of action, efficacy, and duration of Botox® treatment.
- Conditions
- Forehead Rhytid Complex, Glabellar Rhytid Complex
- Being tested
- Botulinum Toxin A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin AProcedure or surgery
Forehead will be injected with Botox.
| Study group | Role | What they receive |
|---|---|---|
| Muscle contractions | Experimental | Under supervision by study personnel, subjects be asked to make active muscle contractions for one hour after Botox injections. Subjects will return for follow-up visits. Receives: Procedure: Botulinum Toxin A |
| No muscle contractions | Active comparator | Patients will be asked to not perform muscle contractions following Botox injections. Receives: Procedure: Botulinum Toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale
A single dermatologist will rate each photograph of the subject's forehead/glabellar rhytid complex at baseline, 1 day, 2 days, 3 days, 4 days, 7 days, 2 weeks, 7 months and 1 day, 7 months and 2 days, 7 months and 3 days, 7 months and 4 days, 7 months and 7 days, and 7 months and 2 weeks. A glabellar wrinkle score and a forehead wrinkle score will be assigned to each photograph. The dermatologist will not know at what point in time the photographs were taken.
Measured: 13 months
Secondary outcomes (2)
Number of Participants with Adverse Events
Side effects and adverse events will be assessed
Measured: 13 months
Level of Satisfaction
Patients will be asked to rate their satisfaction
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startJan 2012
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forehead Rhytid ComplexStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 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
- NCT01688076
- Sponsor's protocol ID
- STU56722
- Status last verified
- Jun 2026
- First submitted
- 4 Apr 2012
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection: Impact of Muscle Contraction on Onset of Action, Efficacy, and Duration of Treatment
- ClinicalTrials.gov ID
- NCT01688076
- Acronym / sponsor ID
- STU56722
- Conditions
- Forehead Rhytid Complex, Glabellar Rhytid Complex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 19 Sep 2012 (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.
This cross-over design study will evaluate the onset of action, efficacy, and duration of botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without subsequent muscle contraction.
Detailed description
In this cross-over design study, the investigators will evaluate whether active muscle contraction following Botox® injection of the forehead/glabellar rhytid complex will impact the onset of action, efficacy, and duration of Botox® treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle contractions | Experimental | Procedure: Botulinum Toxin AUnder supervision by study personnel, subjects be asked to make active muscle contractions for one hour after Botox injections. Subjects will return for follow-up visits. |
| No muscle contractions | Active comparator | Procedure: Botulinum Toxin APatients will be asked to not perform muscle contractions following Botox injections. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In good health
- Is 18-65 years of age
- Has static and dynamic forehead/glabellar wrinkles
- Has decided to receive Botox® treatment for their forehead/glabellar wrinkles
- Has the willingness and ability to understand and provide informed consent and communicate with the investigator
Key exclusion criteria (21 listed)
- Pregnant or lactating
- Has received the following treatments in the forehead or glabellar region:
- Is planning to receive within the next year, 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 year
- Has an active infection in the forehead or glabellar region (excluding mild acne)
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 AForehead will be injected with Botox. | Procedure or surgery | Muscle contractions, No muscle contractions |
Primary outcome
Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale
Time frame: 13 months
A single dermatologist will rate each photograph of the subject's forehead/glabellar rhytid complex at baseline, 1 day, 2 days, 3 days, 4 days, 7 days, 2 weeks, 7 months and 1 day, 7 months and 2 days, 7 months and 3 days, 7 months and 4 days, 7 months and 7 days, and 7 months and 2 weeks. A glabellar wrinkle score and a forehead wrinkle score will be assigned to each photograph. The dermatologist will not know at what point in time the photographs were taken.
2 secondary outcomes
Number of Participants with Adverse Events
Time frame: 13 months
Level of Satisfaction
Time frame: 7 months
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 1 Jul 2026.
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 Forehead Rhytid Complex and Glabellar Rhytid Complex, 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 6 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: finished, 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. 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?
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?
Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale (time frame: 13 months). 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.