Facial WrinklesNCT02122536
Split-Face Prospective Study Comparing Botox to Xeomin for the Treatment of Facial Wrinkles
A study testing Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects and Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjects in people with Facial Wrinkles, run by YMD Eye and Face at 1 site in United States.
Trial summary
The aim of this prospective, randomized, double-blind, intraindividual split face study will be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial wrinkles using a 1:1 dose ratio. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles
- What is being tested?
- Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects and Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Nov 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- males and females age 18 or older.
Who cannot join
- Previous treatment with a neuromodulator in the last 6 months
- previous brow lift
- currently pregnant or breastfeeding
- a history of neurological disease or deficit
- an active facial skin infection
- an allergy to neuromodulators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Split-Face, Double-blind, Single Center, Prospective Study Comparing OnabotulinumtoxinA to IncobotulinumtoxinA
The aim of this prospective, randomized, double-blind, intraindividual split face study will be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial wrinkles using a 1:1 dose ratio.
Read the detailed description
Patients will be randomized to which side of the face will be injected with onabotulinumtoxinA and incobotulinumtoxinA. A total dose of 22.5 units of onabotulinumtoxinA and 22.5 units of incobotulinumtoxinA will be administered at baseline to the respected side of the face. One vial (100 MU) of BoNTA will be reconstituted with 2.0 mL of 0.9% sterile saline solution. Similarly, one vial (100 MU) of BTXCo will be reconstituted with 2.0 mL of 0.9% sterile saline solution. 2.5 units of the respective neurotoxin will be administered to three sites in the crow's feet area on each side (7.5 units total for one side), 2.5 units to two locations of the forehead on each side (5 units total for one side), and 5.0 units to two locations in the glabella on each side(10 units total for one side). The duration of the study will be 4 months. The followup visits after the initial injections will be at 3 days, 2 weeks, 3 months, and 4 months after the initial treatment. At each of these visits, standardized digital photographs of the treated facial area will be taken. Both static and dynamic photos will be taken of each region. At the conclusion of the study, three independent raters will individually perform blind assessments of the photographs according to the Validated Assessment Scaled for the Upper Face published by Flynn et al 2012.
- Conditions
- Facial Wrinkles
- Being tested
- Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects, Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjectsDrug
Also called incobotulinumtoxinA (Xeomin)
Subjects were randomized to which side of the face would be treated with Xeomin.
Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjectsDrug
Also called onabotulinumtoxinA (Botox)
Subjects were randomized to which side of the upper face would be treated with Botox
| Study group | Role | What they receive |
|---|---|---|
| Xeomin right side; Xeomin to left side of face | Active comparator | Patients were randomized as to which side of the face was treated with Xeomin. Receives: Drug: Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects |
| Botox right side; Botox to left side | Active comparator | Patients were randomized as to which side of the face was treated with Botox. Receives: Drug: Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wrinkles Score
Objective assessment of change in wrinkles score pre and post injection of the crow's feet, glabella, and forehead using the "Validated Assessment Scaled for the Upper Face" published by Flynn et al. 2012. At the end of the study the delta wrinkle score from pre-injection to each followup assessment for each area will be calculated.
Measured: Preinjection assessment; assessment at 3 days, 2 weeks, 3 months, 4 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Facial WrinklesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- YMD Eye and Face
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Hill Yeilding, YMD Eye and Face
- Investigators
- Ruth H Yeilding, MD, Principal investigator, YMD Eye & Face
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122536
- Sponsor's protocol ID
- 318060-3
- Status last verified
- Apr 2014
- First submitted
- 30 Oct 2013
- Last updated
- 24 Apr 2014
- Results posted
- No
Publications
Flynn TC, Carruthers A, Carruthers J, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Kerscher M, de Maio M, Mohrmann C, Narins RS, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Fey C, Jones D. Validated assessment scales for the upper face. Dermatol Surg. 2012 Feb;38(2 Spec No.):309-19. doi: 10.1111/j.1524-4725.2011.02248.x.
PubMed 22316187Yeilding RH, Fezza JP. A Prospective, Split-Face, Randomized, Double-Blind Study Comparing OnabotulinumtoxinA to IncobotulinumtoxinA for Upper Face Wrinkles. Plast Reconstr Surg. 2015 May;135(5):1328-1335. doi: 10.1097/PRS.0000000000001255.
PubMed 25919246
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split-Face, Double-blind, Single Center, Prospective Study Comparing OnabotulinumtoxinA to IncobotulinumtoxinA
- ClinicalTrials.gov ID
- NCT02122536
- Acronym / sponsor ID
- 318060-3
- Conditions
- Facial Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- YMD Eye and FaceUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Apr 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 aim of this prospective, randomized, double-blind, intraindividual split face study will be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial wrinkles using a 1:1 dose ratio.
Detailed description
Patients will be randomized to which side of the face will be injected with onabotulinumtoxinA and incobotulinumtoxinA. A total dose of 22.5 units of onabotulinumtoxinA and 22.5 units of incobotulinumtoxinA will be administered at baseline to the respected side of the face. One vial (100 MU) of BoNTA will be reconstituted with 2.0 mL of 0.9% sterile saline solution. Similarly, one vial (100 MU) of BTXCo will be reconstituted with 2.0 mL of 0.9% sterile saline solution. 2.5 units of the respective neurotoxin will be administered to three sites in the crow's feet area on each side (7.5 units total for one side), 2.5 units to two locations of the forehead on each side (5 units total for one side), and 5.0 units to two locations in the glabella on each side(10 units total for one side). The duration of the study will be 4 months. The followup visits after the initial injections will be at 3 days, 2 weeks, 3 months, and 4 months after the initial treatment. At each of these visits, standardized digital photographs of the treated facial area will be taken. Both static and dynamic photos will be taken of each region. At the conclusion of the study, three independent raters will individually perform blind assessments of the photographs according to the Validated Assessment Scaled for the Upper Face published by Flynn et al 2012.
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 |
|---|---|---|
| Xeomin right side; Xeomin to left side of face | Active comparator | Drug: Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjectsPatients were randomized as to which side of the face was treated with Xeomin. |
| Botox right side; Botox to left side | Active comparator | Drug: Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjectsPatients were randomized as to which side of the face was treated with Botox. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- males and females age 18 or older.
Key exclusion criteria (6 listed)
- Previous treatment with a neuromodulator in the last 6 months
- previous brow lift
- currently pregnant or breastfeeding
- a history of neurological disease or deficit
- an active facial skin infection
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 |
|---|---|---|
| Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjectsAlso: incobotulinumtoxinA (Xeomin)Subjects were randomized to which side of the face would be treated with Xeomin. | Drug | Xeomin right side; Xeomin to left side of face |
| Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjectsAlso: onabotulinumtoxinA (Botox)Subjects were randomized to which side of the upper face would be treated with Botox | Drug | Botox right side; Botox to left side |
Primary outcome
Change in Wrinkles Score
Time frame: Preinjection assessment; assessment at 3 days, 2 weeks, 3 months, 4 months post-injection
Objective assessment of change in wrinkles score pre and post injection of the crow's feet, glabella, and forehead using the "Validated Assessment Scaled for the Upper Face" published by Flynn et al. 2012. At the end of the study the delta wrinkle score from pre-injection to each followup assessment for each area will be calculated.
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 24 Apr 2014.
- Background: PubMed 22316187Flynn TC, Carruthers A, Carruthers J, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Kerscher M, de Maio M, Mohrmann C, Narins RS, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Fey C, Jones D. Validated assessment scales for the upper face. Dermatol Surg. 2012 Feb;38(2 Spec No.):309-19. doi: 10.1111/j.1524-4725.2011.02248.x.
- Derived from this study: PubMed 25919246Yeilding RH, Fezza JP. A Prospective, Split-Face, Randomized, Double-Blind Study Comparing OnabotulinumtoxinA to IncobotulinumtoxinA for Upper Face Wrinkles. Plast Reconstr Surg. 2015 May;135(5):1328-1335. doi: 10.1097/PRS.0000000000001255.
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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.
Ruth H Yeilding, MD principal investigator
YMD Eye & Face
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects and Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjects in people with Facial Wrinkles, run by YMD Eye and Face 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 1 inclusion and 6 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 24 Apr 2014. 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?
Change in Wrinkles Score (time frame: Preinjection assessment; assessment at 3 days, 2 weeks, 3 months, 4 months post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02122536, which also lists 2 linked publications.
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 24 Apr 2014.