WrinklesEarly Phase 1NCT02019004
A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles
A Early Phase 1 study testing Onabotulinum Toxin A and Incobotulinum Toxin A in people with Wrinkles, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of Botox® (Onabotulinum Toxin A) versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical lines between the eyebrows) wrinkles. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- What is being tested?
- Onabotulinum Toxin A and Incobotulinum Toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2027
- Phase
- Early Phase 1
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females and males
- In good health
- Is 20-65 years of age
- Has static and moderate dynamic forehead/glabellar wrinkles
- Has willingness and the ability to understand and provide informed consent and communicate with the study staff
Who cannot join
- Pregnant or lactating
- Younger than 20 or older than 65 years of age
- 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
Show all 21Show fewer
- 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
- Taking aminoglycoside
- Is currently using anticoagulation therapy
- Has a history of bleeding disorders
- Has a mental illness
- Unable to understand the protocol or to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Treatment of Forehead/Glabellar Rhytide Complex With Onabotulinum Toxin A Versus Incobotulinum Toxin A Injection: A Split-face, Double-blinded, Randomized Control Trial
The purpose of this study is to compare the effectiveness of Botox® (Onabotulinum Toxin A) versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical lines between the eyebrows) wrinkles.
Read the detailed description
Subjects will be screened, photographed, assessed, and randomized to be injected with onabotulinum toxin A on one side and incobotulinum toxin A on the other side during their first clinic visit. Subjects will return for a 2 week, 2 month, 3 month, 4 month, 5 month, and 6 month follow-up to have photographs taken by the unblinded research assistant at relaxed and full contraction.
This study is a pilot study designed to determine feasibility of these procedures.
- Conditions
- Wrinkles
- Being tested
- Onabotulinum Toxin A, Incobotulinum Toxin A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onabotulinum Toxin ADrug
Also called Botox
Incobotulinum Toxin ADrug
Also called Xeomin
| Study group | Role | What they receive |
|---|---|---|
| Onabotulinum Toxin A | Active comparator | One side of the face will be randomized to receive Onabotulinum Toxin A injections in the forehead and glabellar region of the face. Receives: Drug: Onabotulinum Toxin A |
| Incobotulinum Toxin A | Active comparator | The other side of the face will be randomized to receive Incobotulinum Toxin A injections in the glabellar and forehead region of the face. Receives: Drug: Incobotulinum Toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glabellar wrinkle score from baseline to 6 months for botox vs. xeomin
Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The glabellar wrinkle rating is:
0: no facial wrinkles
- mild facial wrinkles
- moderate facial wrinkles
- severe facial wrinkling
Measured: At baseline and at 6 months
Change in forehead wrinkle score from baseline to 6 months for botox vs. xeomin
Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The forehead wrinkle Merz rating is:
0: no wrinkles
- minimal wrinkles
- mild wrinkles
- moderate wrinkles
- severe wrinkles
Measured: At baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startNov 2013
- 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 WrinklesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
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
- NCT02019004
- Sponsor's protocol ID
- STU83962
- Status last verified
- Jun 2026
- First submitted
- 12 Nov 2013
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- 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 Forehead/Glabellar Rhytide Complex With Onabotulinum Toxin A Versus Incobotulinum Toxin A Injection: A Split-face, Double-blinded, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02019004
- Acronym / sponsor ID
- STU83962
- Conditions
- Wrinkles
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Dec 2013 (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 compare the effectiveness of Botox® (Onabotulinum Toxin A) versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical lines between the eyebrows) wrinkles.
Detailed description
Subjects will be screened, photographed, assessed, and randomized to be injected with onabotulinum toxin A on one side and incobotulinum toxin A on the other side during their first clinic visit. Subjects will return for a 2 week, 2 month, 3 month, 4 month, 5 month, and 6 month follow-up to have photographs taken by the unblinded research assistant at relaxed and full contraction.
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 |
|---|---|---|
| Onabotulinum Toxin A | Active comparator | Drug: Onabotulinum Toxin AOne side of the face will be randomized to receive Onabotulinum Toxin A injections in the forehead and glabellar region of the face. |
| Incobotulinum Toxin A | Active comparator | Drug: Incobotulinum Toxin AThe other side of the face will be randomized to receive Incobotulinum Toxin A injections in the glabellar and forehead region of the face. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females and males
- In good health
- Is 20-65 years of age
- Has static and moderate dynamic forehead/glabellar wrinkles
- Has willingness and the ability to understand and provide informed consent and communicate with the study staff
Key exclusion criteria (21 listed)
- Pregnant or lactating
- Younger than 20 or older than 65 years of age
- 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
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 |
|---|---|---|
| Onabotulinum Toxin AAlso: Botox | Drug | Onabotulinum Toxin A |
| Incobotulinum Toxin AAlso: Xeomin | Drug | Incobotulinum Toxin A |
Primary outcome
Change in glabellar wrinkle score from baseline to 6 months for botox vs. xeomin
Time frame: At baseline and at 6 months
Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The glabellar wrinkle rating is: 0: no facial wrinkles 1. mild facial wrinkles 2. moderate facial wrinkles 3. severe facial wrinkling
Change in forehead wrinkle score from baseline to 6 months for botox vs. xeomin
Time frame: At baseline and at 6 months
Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The forehead wrinkle Merz rating is: 0: no wrinkles 1. minimal wrinkles 2. mild wrinkles 3. moderate wrinkles 4. severe wrinkles
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 Early Phase 1 study testing Onabotulinum Toxin A and Incobotulinum Toxin A in people with Wrinkles, 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 5 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in glabellar wrinkle score from baseline to 6 months for botox vs. xeomin (time frame: At baseline and at 6 months). The study lists 2 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 1 Jul 2026.