Moderate Upper Facial LinesPhase 1LONG-SETNCT04736745
Study to Evaluate the Safety and Efficacy of IPN59011 in Improving the Appearance of Moderate to Severe Upper Facial Lines.
A Phase 1 study testing IPN59011 and Azzalure in people with Moderate Upper Facial Lines and Severe Upper Facial Lines, run by Ipsen at 1 site in Germany.
Trial summary
The purpose of the protocol, is to assess the safety and efficacy profile of IPN59011 compared to a placebo. IPN59011 is expected to work longer than product already marketed in the treatment of subjects with moderate to severe facial wrinkles. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate Upper Facial Lines, Severe Upper Facial Lines
- What is being tested?
- IPN59011 and Azzalure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- 10 Feb 2021to 28 Oct 2022
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent prior to any study related procedures.
- Female and male subjects between 18 and 65 years of age, inclusive (for dose escalation females only)
- Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the ILA using a validated 4-point photographic scale.
- Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the SSA using a validated 4-point categorical scale.
- Moderate or severe (Grade 2 or 3) Forehead Lines (FHL) at maximum contraction and moderate to severe GL at maximum contraction at Baseline or moderate to severe (Grade 2 or 3) Lateral Canthal Lines (LCL) at maximum contraction (Stage as assessed by the ILA using a validated 4-point photographic scale).
- Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL at maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL at maximum contraction (Stage as assessed by the ILA using a validated 4-point photographic scale).
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- Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL at maximum contraction, as assessed by the by the SSA using a validated 4-point categorical scale.
- Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL at maximum contraction, as assessed by the by the SSA using a validated 4-point categorical scale.
- Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at Baseline, as assessed by the subject's level of satisfaction.
- A negative pregnancy test (for females of childbearing potential only). Non-childbearing potential is defined as postmenopausal for at least 1 year; surgical sterilisation at least 3 months before entering the study; or hysterectomy.
- Subject has both the time and the ability to complete the study and comply with study instructions.
Who cannot join
- Previous treatment with any Botox (BTX) serotype (for dose escalation at least) or any recent treatment (within the past 6 months prior to Baseline for the rest of the study) with any BTX serotype.
- Any prior treatment with permanent fillers in the upper face including the GL, FHL and LCL area.
- Any prior treatment with long lasting dermal fillers in the upper face including the GL area within the past 3 years and/or skin abrasions/resurfacing (whatever the interventional technic used) within the past 5 years, or photo rejuvenation or skin/vascular laser intervention within the 12 months prior to Baseline.
- Any planned facial cosmetic surgery during the study.
- A history of eyelid blepharoplasty or brow lift within the past 5 years.
- An inability to substantially reduce GL by physically spreading them apart or lack of capacity to frown.
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- An active infection or other skin problems in the upper face including the GL, FHL and LCL area (e.g. acute acne lesions or ulcers).
- Use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study treatment, including medications affecting bleeding disorders (e.g. antiplatelet agents and/or anticoagulants given for treatment or prevention of cardiovascular/cerebrovascular diseases).
- Pregnant women, nursing women, premenopausal women or women of childbearing potential (i.e. not surgically sterile or 1 year postmenopausal) not willing to practice a highly effective form of contraception method at the beginning of the study, for the duration of the study and for a minimum of 12 weeks following last administration of study treatment. Highly effective methods of contraception are defined as methods of birth control which result in a low failure rate (less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, intrauterine devices, or vasectomised partner.
- Male subjects who are not vasectomised and who have female partners of childbearing potential and are not willing to use condoms with spermicide throughout study participation for a minimum of 12 weeks following initial double-blind administration of the treatment.
- Positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus (HIV) or a diagnosis of acquired immunodeficiency syndrome.
- A history of drug or alcohol abuse.
- Use of any experimental device within 30 days or use of any treatment with an experimental drug within five times the documented terminal half-life of the respective drug or its metabolites or if the half life is unknown within 30 days prior to the start of the study (prior to Baseline) and during the conduct of the study.
- Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the subject's participation in the study.
- Use of medications that affect neuromuscular transmission, such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within the past 30 days prior to Baseline.
- A history of facial nerve palsy.
- Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
- Known allergy or hypersensitivity to BTX, or any excipients of IPN59011 or Azzalure, or allergy to cow's milk protein.
- Any known medical condition that may put the subject at increased risk in regard to exposure to BoNT of any serotype (i.e. myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)
- The presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function), laboratory finding or circumstance that, in the judgment of the investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
- Any uncontrolled systemic disease or other significant medical condition considered as an exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib/II, Multicentre, Double-blind, Randomised, Placebo-controlled Dose Escalation and Dose Finding Study to Evaluate the Safety and Efficacy of IPN59011 in Improving the Appearance of Moderate to Severe Upper Facial Lines
The purpose of the protocol, is to assess the safety and efficacy profile of IPN59011 compared to a placebo. IPN59011 is expected to work longer than product already marketed in the treatment of subjects with moderate to severe facial wrinkles.
- Being tested
- IPN59011, Azzalure, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPN59011Biological
Powder and solvent for solution for injection
AzzalureBiological
Powder for solution for injection
PlaceboDrug
Powder for solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | One single injection of study medication (IPN59011 or Placebo) will be injected locally. IPN59011 is injected in a dose-escalation manner.
In total for this stage at least 40 subjects. Receives: Biological: IPN59011; Drug: Placebo |
| Dose ranging | Experimental | Up to two IPN59011dose(s) groups will be included in parallel groups versus Azzalure group and placebo group. One single injection of study medication will be injected locally into several sites.
In total for this stage at least 70 subjects. Receives: Biological: IPN59011; Biological: Azzalure; Drug: Placebo |
| Additional dose ranging | Experimental | Dose-ranging for three additional placebo-controlled parallel groups. One single injection of study medication will be injected locally into several sites, concomitantly and non-concomitantly.
In total for this stage at least 110 subjects. Receives: Biological: IPN59011; Drug: Placebo |
| Total dose for Upper Facial Lines | Experimental | One single injection of study medication will be injected locally into Upper Facial Lines.
In total for this stage approximately 48 subjects. Receives: Biological: IPN59011; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the Treatment-Emergent Adverse Events (TEAEs) at each dose for dose escalation
Measured: from baseline until the end of study (9 months)
Incidence of Serious Adverse Events (SAEs) at each dose for dose escalation
Measured: from baseline until the end of study (9 months)
Incidence of clinically significant Adverse Events (AEs) at each dose for dose escalation
Measured: from baseline until the end of study (9 months)
Incidence of AEs (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs) for dose escalation
Measured: from baseline until the end of study (9 months)
Presence of botulinum neurotoxin serotype A (BoNT-A) antibodies and IPN59011 antibodies and titres (binding and neutralizing)
Measured: from baseline until the end of study (9 months)
Response to treatment measured by the composite response of 2-grade improvement on investigator's live assessment (ILA) at maximum contraction.
ILA: a validated 4-point photographic scale to assess the severity and appearance of the GLs at maximum frown and at rest where 0 is "no lines are noticeable" and 3 is "lines are extremely pronounced".
Measured: Day 29
Response to treatment measured by the composite response of 2-grade improvement on subject's self-assessment (SSA) at maximum contraction.
SSA: a validated 4-point categorical scale to assess the appearance of their Glabellar Lines (GLs) at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles".
Measured: Day 29
Secondary outcomes (9)
Response to treatment as measured by the reduction of ≥2 grades on the ILA at maximum contraction
Measured: From the baseline to the end of the study (9 months)
Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at maximum contraction
Measured: From the baseline to the end of the study (9 months)
Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at rest
Measured: From the baseline to the end of the study (9 months)
Response to treatment as measured by the reduction of ≥2 grades on the SSA at maximum contraction
Measured: From the baseline to the end of the study (9 months)
Response to treatment as achieved by a score of "none" or "mild" as measured by the SSA at maximum contraction
Measured: From the baseline to the end of the study (9 months)
Response to treatment as achieved by a score of "very satisfied" or "satisfied" on the Subject Level of Satisfaction (SLS)
Measured: From the baseline to the end of the study (9 months)
Duration of treatment response based on ILA and SSA at maximum contraction
Measured: From the baseline to the end of the study (9 months)
Face-Q (overall satisfaction with facial appearance) for Upper Facial Lines (UFL)
Measured: Visits screening, Day 1, Day 15, Day 29, 3 months, 6 months, 9 months
Time to onset of treatment response based on subject diary cards to evaluate the appearance of their lines.
Measured: From Day 1 through Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start10 Feb 2021
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Why it stopped: Sponsor terminated the study due to strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Upper Facial LinesStudies of the same condition, open and under way.
- More trials run by IpsenThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- For dose escalation part Sequential study model will be used. For the rest of the study parallel assignment will be used.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736745
- Sponsor's protocol ID
- D-FR-59011-001
- Other IDs
- 2019-003268-33, 2019
- Acronym
- LONG-SET
- Status last verified
- Jul 2023
- First submitted
- 12 Jan 2021
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Multicentre, Double-blind, Randomised, Placebo-controlled Dose Escalation and Dose Finding Study to Evaluate the Safety and Efficacy of IPN59011 in Improving the Appearance of Moderate to Severe Upper Facial Lines
- ClinicalTrials.gov ID
- NCT04736745
- Acronym / sponsor ID
- LONG-SET / D-FR-59011-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated the study due to strategic considerations
- Enrolment
- 56 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 3 Feb 2021 (actual)
- 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 the protocol, is to assess the safety and efficacy profile of IPN59011 compared to a placebo. IPN59011 is expected to work longer than product already marketed in the treatment of subjects with moderate to severe facial wrinkles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- For dose escalation part Sequential study model will be used. For the rest of the study parallel assignment will be used.
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Biological: IPN59011, Drug: PlaceboOne single injection of study medication (IPN59011 or Placebo) will be injected locally. IPN59011 is injected in a dose-escalation manner. In total for this stage at least 40 subjects. |
| Dose ranging | Experimental | Biological: IPN59011, Biological: Azzalure, Drug: PlaceboUp to two IPN59011dose(s) groups will be included in parallel groups versus Azzalure group and placebo group. One single injection of study medication will be injected locally into several sites. In total for this stage at least 70 subjects. |
| Additional dose ranging | Experimental | Biological: IPN59011, Drug: PlaceboDose-ranging for three additional placebo-controlled parallel groups. One single injection of study medication will be injected locally into several sites, concomitantly and non-concomitantly. In total for this stage at least 110 subjects. |
| Total dose for Upper Facial Lines | Experimental | Biological: IPN59011, Drug: PlaceboOne single injection of study medication will be injected locally into Upper Facial Lines. In total for this stage approximately 48 subjects. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of written informed consent prior to any study related procedures.
- Female and male subjects between 18 and 65 years of age, inclusive (for dose escalation females only)
- Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the ILA using a validated 4-point photographic scale.
- Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the SSA using a validated 4-point categorical scale.
- Moderate or severe (Grade 2 or 3) Forehead Lines (FHL) at maximum contraction and moderate to severe GL at maximum contraction at Baseline or moderate to severe (Grade 2 or 3) Lateral Canthal Lines (LCL) at maximum contraction (Stage as assessed by the ILA using a validated 4-point photographic scale).
Key exclusion criteria (21 listed)
- Previous treatment with any Botox (BTX) serotype (for dose escalation at least) or any recent treatment (within the past 6 months prior to Baseline for the rest of the study) with any BTX serotype.
- Any prior treatment with permanent fillers in the upper face including the GL, FHL and LCL area.
- Any prior treatment with long lasting dermal fillers in the upper face including the GL area within the past 3 years and/or skin abrasions/resurfacing (whatever the interventional technic used) within the past 5 years, or photo rejuvenation or skin/vascular laser intervention within the 12 months prior to Baseline.
- Any planned facial cosmetic surgery during the study.
- A history of eyelid blepharoplasty or brow lift within the past 5 years.
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 |
|---|---|---|
| IPN59011Powder and solvent for solution for injection | Biological | Additional dose ranging, Dose escalation, Dose ranging, Total dose for Upper Facial Lines |
| AzzalurePowder for solution for injection | Biological | Dose ranging |
| PlaceboPowder for solution for injection | Drug | Additional dose ranging, Dose escalation, Dose ranging, Total dose for Upper Facial Lines |
Primary outcome
Incidence of the Treatment-Emergent Adverse Events (TEAEs) at each dose for dose escalation
Time frame: from baseline until the end of study (9 months)
Incidence of Serious Adverse Events (SAEs) at each dose for dose escalation
Time frame: from baseline until the end of study (9 months)
Incidence of clinically significant Adverse Events (AEs) at each dose for dose escalation
Time frame: from baseline until the end of study (9 months)
Incidence of AEs (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs) for dose escalation
Time frame: from baseline until the end of study (9 months)
Presence of botulinum neurotoxin serotype A (BoNT-A) antibodies and IPN59011 antibodies and titres (binding and neutralizing)
Time frame: from baseline until the end of study (9 months)
Response to treatment measured by the composite response of 2-grade improvement on investigator's live assessment (ILA) at maximum contraction.
Time frame: Day 29
ILA: a validated 4-point photographic scale to assess the severity and appearance of the GLs at maximum frown and at rest where 0 is "no lines are noticeable" and 3 is "lines are extremely pronounced".
Response to treatment measured by the composite response of 2-grade improvement on subject's self-assessment (SSA) at maximum contraction.
Time frame: Day 29
SSA: a validated 4-point categorical scale to assess the appearance of their Glabellar Lines (GLs) at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles".
9 secondary outcomes
Response to treatment as measured by the reduction of ≥2 grades on the ILA at maximum contraction
Time frame: From the baseline to the end of the study (9 months)
Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at maximum contraction
Time frame: From the baseline to the end of the study (9 months)
Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at rest
Time frame: From the baseline to the end of the study (9 months)
Response to treatment as measured by the reduction of ≥2 grades on the SSA at maximum contraction
Time frame: From the baseline to the end of the study (9 months)
Response to treatment as achieved by a score of "none" or "mild" as measured by the SSA at maximum contraction
Time frame: From the baseline to the end of the study (9 months)
Response to treatment as achieved by a score of "very satisfied" or "satisfied" on the Subject Level of Satisfaction (SLS)
Time frame: From the baseline to the end of the study (9 months)
Duration of treatment response based on ILA and SSA at maximum contraction
Time frame: From the baseline to the end of the study (9 months)
Face-Q (overall satisfaction with facial appearance) for Upper Facial Lines (UFL)
Time frame: Visits screening, Day 1, Day 15, Day 29, 3 months, 6 months, 9 months
Time to onset of treatment response based on subject diary cards to evaluate the appearance of their lines.
Time frame: From Day 1 through Day 8
Results and safety
The study was stopped early (reason given: Sponsor terminated the study due to strategic considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPN59011 and Azzalure in people with Moderate Upper Facial Lines and Severe Upper Facial Lines, run by Ipsen at 1 site in Germany.
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 11 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: stopped early, as of the sponsor's last update on 14 Jul 2023. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Sponsor terminated the study due to strategic considerations). Results are not available in the source record.
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?
Incidence of the Treatment-Emergent Adverse Events (TEAEs) at each dose for dose escalation (time frame: from baseline until the end of study (9 months)). The study lists 7 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 14 Jul 2023; AzTrials last refreshed its copy on 26 Oct 2026.