Forehead/Glabellar Rhytid ComplexesNCT01186835
Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone
A study testing Combination Botulinum Toxin A and Hyaluronic Acid and Botulinum Toxin A in people with Forehead/Glabellar Rhytid Complexes, run by Northwestern University at 1 site in United States.
Trial summary
The objective of this study is to determine whether the use of botulinum toxin (Dysport ®) in conjunction with a hyaluronic acid filler (Restylane®) will improve the appearance of wrinkles on the forehead and glabella (area between the eyebrows) better than botulinum toxin alone. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Forehead/Glabellar Rhytid Complexes
- What is being tested?
- Combination Botulinum Toxin A and Hyaluronic Acid and 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2011
- Phase
- Interventional
- 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 willingness and the ability to understand and provide informed consent and communicate with the investigator
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 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
- Taking aminoglycoside
- Has prior history of nodule formation or hypersensitivity reactions to lidocaine or hyaluronic acid derivatives
- Is currently using anticoagulation therapy
- Has a history of bleeding disorders
- Is unable to understand the protocol or to give informed consent
- Has a mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone: A Split-face, Rater-blinded Randomized Control Trial
The objective of this study is to determine whether the use of botulinum toxin (Dysport ®) in conjunction with a hyaluronic acid filler (Restylane®) will improve the appearance of wrinkles on the forehead and glabella (area between the eyebrows) better than botulinum toxin alone. These two products have been FDA approved to improve the appearance of facial wrinkles.
- Conditions
- Forehead/Glabellar Rhytid Complexes
- Being tested
- Combination Botulinum Toxin A and Hyaluronic Acid, Botulinum Toxin A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination Botulinum Toxin A and Hyaluronic AcidProcedure or surgery
One side of subject's face will randomly be assigned combination treatment.
Botulinum Toxin AProcedure or surgery
Other side of subjects face with receive Botulinum Toxin A treatment alone.
| Study group | Role | What they receive |
|---|---|---|
| Combination Botulinum Toxin A and Hyaluronic Acid | Experimental | One side of face treated with the combination of Botulinum Toxin A and Hyaluronic Acid injections. Receives: Procedure: Combination Botulinum Toxin A and Hyaluronic Acid |
| Botulinum Toxin A alone | Active comparator | Other side of face treated with =Botulinum Toxin A injection alone. Receives: Procedure: Botulinum Toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure:
Two blinded dermatologists will rate each photograph of each subject at baseline, week 2, month 3, and month 6. The raters will provide a glabellar wrinkle score and a forehead wrinkle score for each photograph. The raters will not know what treatments the subjects received or at what point in time the photographs were taken.
Measured: 1 year
Secondary outcomes (1)
Measure: Percent Improvement
- Two blinded dermatologists will also rate the percent improvement between the before and after photographs (Appendix III).
- A live blinded dermatologist will determine which side looks better at week 0, week 2, month 3, and month 6.
- A subject self-evaluation will be administered at week 2, month 3, and month 6.
- A subject satisfaction questionnaire will be administered at month 6.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startFeb 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forehead/Glabellar Rhytid ComplexesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Medicis Pharmaceutical Corporation
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186835
- Sponsor's protocol ID
- MA-stu24810
- Status last verified
- Dec 2021
- First submitted
- 19 Aug 2010
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone: A Split-face, Rater-blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01186835
- Acronym / sponsor ID
- MA-stu24810
- Conditions
- Forehead/Glabellar Rhytid Complexes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Medicis Pharmaceutical Corporation
- Study start
- Feb 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Aug 2010 (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 objective of this study is to determine whether the use of botulinum toxin (Dysport ®) in conjunction with a hyaluronic acid filler (Restylane®) will improve the appearance of wrinkles on the forehead and glabella (area between the eyebrows) better than botulinum toxin alone. These two products have been FDA approved to improve the appearance of facial wrinkles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Botulinum Toxin A and Hyaluronic Acid | Experimental | Procedure: Combination Botulinum Toxin A and Hyaluronic AcidOne side of face treated with the combination of Botulinum Toxin A and Hyaluronic Acid injections. |
| Botulinum Toxin A alone | Active comparator | Procedure: Botulinum Toxin AOther side of face treated with =Botulinum Toxin A injection alone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In good health
- Is 18-65 years of age
- Has static and dynamic forehead/glabellar wrinkles
- Has willingness and the 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 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)
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 |
|---|---|---|
| Combination Botulinum Toxin A and Hyaluronic AcidOne side of subject's face will randomly be assigned combination treatment. | Procedure or surgery | Combination Botulinum Toxin A and Hyaluronic Acid |
| Botulinum Toxin AOther side of subjects face with receive Botulinum Toxin A treatment alone. | Procedure or surgery | Botulinum Toxin A alone |
Primary outcome
Measure:
Time frame: 1 year
Two blinded dermatologists will rate each photograph of each subject at baseline, week 2, month 3, and month 6. The raters will provide a glabellar wrinkle score and a forehead wrinkle score for each photograph. The raters will not know what treatments the subjects received or at what point in time the photographs were taken.
1 secondary outcome
Measure: Percent Improvement
Time frame: 1 year
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 3 Dec 2021.
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 study testing Combination Botulinum Toxin A and Hyaluronic Acid and Botulinum Toxin A in people with Forehead/Glabellar Rhytid Complexes, 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 4 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 3 Dec 2021. 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.
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?
Measure: (time frame: 1 year). 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 3 Dec 2021.