Moderate to Severe Upper Facial LinesPhase 1/2LANTICNCT04821089

A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines

A Phase 1/2 study testing Corabotase and Dysport in people with Moderate to Severe Upper Facial Lines, run by Ipsen at 10 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this study is to assess the safety and efficacy profile of increasing doses of Corabotase (also known as IPN10200) in comparison to placebo, with the aim to discover the doses(s) that offer the best efficacy/safety profile when used for the treatment of moderate to severe Upper Facial Lines. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Moderate to Severe Upper Facial Lines
What is being tested?: Corabotase and Dysport
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 727 participants
Where: 10 sitesin 2 countries
Study dates: 6 Apr 2021to 19 Aug 2027
Phase: Phase 1/2

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

Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
Moderate or severe (Grade 2 or 3) GL (Stage 1) 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 (Stage 1) at maximum contraction at Baseline, as assessed by the SSA using a validated 4-point categorical scale.
Moderate or severe (Grade 2 or 3) FHL (Stage 2) at maximum contraction and moderate to severe GL at maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL (Stage 2) at maximum contraction (Stage as assessed by the ILA using a 4-point photographic scale).
Moderate or severe (Grade 2 or 3) FHL (Stage 3) at maximum contraction and moderate to severe GL at maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL (Stage 3) at maximum contraction (Stage as assessed by the ILA using a 4-point photographic scale).
Moderate or severe (Grade 2 or 3) FHL (Stage 2) at maximum contraction and moderate to severe GL maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL (Stage 2) at maximum contraction as assessed by the SSA using a 4-point photographic scale.

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Moderate or severe (Grade 2 or 3) FHL (Stage 3) at maximum contraction and moderate to severe GL maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL (Stage 3) at maximum contraction, as assessed by the SSA using a 4-point photographic scale.
Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines (Stages 1 to 3) at Baseline, as assessed by the SLS.
Male and female participants (only female for Stage 1/Step 1). Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Capable of giving signed informed consent includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Participant has both the time and the ability to complete the study and comply with study instructions.
Does not reside in an institution by administrative or court order.
Is not a sponsor employee or clinical research unit personnel directly affiliated with the study or is not an immediate family member. Immediate family is defined as a spouse, parent, child or sibling whether biological or legally adopted.

Who cannot join

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).
A history of eyelid blepharoplasty or brow lift within the past 5 years
A history of facial nerve palsy.
Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
Any known medical condition that may put the participant at increased risk in regard to exposure to BoNT of any serotype (i.e. myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)
Has COVID-19 illness or a known positive SARS-CoV-2 test (Stage 1), or the presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function)

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Previous treatment with any BoNT serotype for Stage 1 / Step 1 or any recent treatment (within the past 9 months prior to baseline) with any BoNT serotype for Stage 1 / Step 2, Stage 1/Step 3, Stages 2 and 3. Participants treated in earlier Stages/Steps of the study must not be included in any later Stages/Steps.
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 or any permanent procedures in the upper face inclusion 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.
Use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study intervention. Therapy considered necessary for the participant's welfare may be given at the discretion of the investigator.
Use of medications that affect neuromuscular transmission, such as curare-like non depolarising agents, lincosamides, polymyxins, anticholinesterases, aminoglycoside antibiotics and systemic retinoids, within the past 30 days prior to baseline are prohibited or a longer washout period of at least five half-lives might be required, as deemed appropriate by the investigator for longer-acting medications. Topical use of for example aminoglycoside medications or topical retinoids on the face apart from the area of injection would be acceptable.
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 halflife is unknown within 30 days prior to the start of the study (prior to Baseline) and during the conduct of the study.
Known positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus (HIV) or a diagnosis of acquired immunodeficiency syndrome.
Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the participant's participation in the study
An inability to substantially lessen GL and/or horizontal forehead rhytids even by physically spreading them apart as determined by the investigator.
Known allergy or hypersensitivity to BoNT or any excipients of IPN10200 or Dusport/Azzalure, or allergy to cow's milk protein.
A history of drug or alcohol abuse
Pregnant women, nursing women, premenopausal women or women of childbearing potential not willing to practice a highly effective form of contraception method
Male participants who are not vasectomized and who have female partners of childbearing potential and are not willing to use condoms with spermicide throughout study participation.
Any uncontrolled systemic disease or other significant medical condition which would be harmful for the participant to be entered into the study or continue participation.

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

Germany7 sites

CRS Clinical Research Services Berlin GMBH
Berlin, 13353
Interdisciplinary Study Association
Berlin
ROSENPARK RESEARCH GmbH
Darmstadt
Privatpraxis Dr. Hilton & Partner
Düsseldorf
Fachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft
Hamburg
Interdisciplinary Study Association
Kassel, State of Berlin
Dermatologische Gemeinschaftspraxis Blankenfelde-Mahlow
Mahlow

Other trials in Germany

France3 sites

MEDITI - Clinique Del Mar
Antibes
Aimed S.A.S
Lyon
Clinique de Chirurgie Esthétique Iéna
Paris

Other trials in France

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 IPN10200 in Improving the Appearance of Moderate to Severe Upper Facial Lines in Adults

This study will be conducted in three stages. The full study (including all stages) will have a maximum 727 participants.

Stage 1 (phase Ib \& II)

Step 1 (Phase Ib): a dose-escalation first-in-human step in participants with moderate to severe Glabellar Lines (GL)
Step 2 (Phase II): dose ranging step in participants with moderate to severe GL as compared with Dysport
Step 3 (Phase II): dose finding step in participants with moderate to severe GL as compared with Dysport, followed by an open label (OL) phase for the highest dose cohort to assess the long-term safety and efficacy of Corabotase. In the OL phase, participants may receive repeat administrations of Corabotase for up to three additional cycles (up to four treatment cycles in total during the study).

Stage 2 (phase II) - An evaluation of efficacy and safety of Corabotase in one of the following regions: GL + forehead lines (FHL), forehead lines (FHL) or lateral canthal lines (LCL)

Stage 3 (phase II)

A safety and efficacy evaluation of Corabotase in all three regions (GL, FHL and LCL)

Conditions: Moderate to Severe Upper Facial Lines
Being tested: Corabotase, IPN10200 Placebo, Dysport

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CorabotaseBiological
Stage 1: Several different doses will be administrated in a dose-escalation manner.
One single injection will be injected locally into several sites across the glabellar region.
Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions.
Stage 3: One single injection will be injected locally into several sites across the upper facial area.
IPN10200 PlaceboBiological
Stage 1: One single injection of study intervention will be injected locally into several sites across the glabellar region.
Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions.
Stage 3: One single injection will be injected locally into several sites across the upper facial area.
DysportBiological
Single administration of study intervention in stage 1 / step 2 and 3 only

Study groups in NCT04821089
Study group	Role	What they receive
Corabotase group	Experimental	Stage 1/Step 1: Several cohorts of participants will be randomized in a ratio of 3:1 (Corabotase:placebo)in a dose-escalation manner. The decision to escalate to the next dose for each cohort will be based on Data Monitoring Committee (DMC) recommendation. Stage 1/Step 2: parallel dose-ranging manner Stage 1/Step 3: each cohort will include three treatment groups randomised in a ratio of 4:1:1 (Corabotase: placebo:dysport) The decision to escalate to the next dose for each cohort will be based on DMC recommendation . Stage 2: the dose(s) chosen for administration in each region of the face will be selected on the basis of the intermediate analyses of Stage 1/Step 3. Participants will be randomised for each group in a ratio of 4:4:1 (Corabotase:Corabotase:placebo). Stage 3: total dose for each region defined in Stages 1 and 2. Participants will be randomised for each group in a ratio of 3:1. Receives: Biological: Corabotase
Placebo group	Placebo comparator	Stage 1/Step 1: Several cohorts of participants will be randomized in a ratio of 3:1 in a dose-escalation manner. The decision to escalate to the next dose for each cohort will be based on Data Monitoring Committee (DMC) recommendation. Stage 1/Step 2: parallel dose-ranging manner Stage 1/Step 3: each cohort will include three treatment groups randomised in a ratio of 4:1:1 (Corabotase:Corabotase: placebo) The decision to escalate to the next dose for each cohort will be based on DMC recommendation. Stage 2: the dose(s) chosen for administration in each region of the face will be selected on the basis of the intermediate analyses of Stage 1/Step 3. Participants will be randomised for each group in a ratio of 4:4:1 (Corabotase:Corabotase:placebo). Stage 3: total dose for each region defined in Stages 1 and 2. Participants will be randomised for each group in a ratio of 3:1.(Corabotase:placebo) Receives: Biological: IPN10200 Placebo
Dysport group (stage 1 / step 2 and 3 only)	Active comparator	Not described Receives: Biological: Dysport

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of treatment emergent adverse events (TEAEs) at each dose
At Stage 1/Step 1, Stage 3
Measured: From the baseline to the end of the study (9 months)
Incidence of serious adverse events (SAEs) at each dose
At Stage 1/Step 1, Stage 3
Measured: From the baseline to the end of the study (9 months)
Incidence of Adverse Events (AEs) (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs)
At Stage 1/Step 1, Stage 3
Measured: From the baseline to the end of the study (9 months)
Response to treatment at Stage 2 for the FHL group
Measured by the composite response of ≥ 2-grade improvement on Investigator's Live Assessment (ILA) and subject's self-assessment (SSA) at maximum contraction on the forehead lines:
ILA: a validated 4-point photographic scale to assess the severity and appearance of the Forehead Lines (FHL) at maximum frown and at rest where 0 is "none" and 3 is "severe"
SSA: a validated 4-point categorical scale to assess the appearance of their FHLs at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles"
Measured: At Week 4
Response to treatment at Stage 2 for the glabellar lines (GL)+ FHL group
Measured by the composite response of ≥ 2-grade improvement on ILA and SSA at maximum contraction on the forehead lines (FHL) area:
ILA: a validated 4-point photographic scale to assess the severity and appearance of the GLs and FHLs at maximum frown and at rest where 0 is "none" and 3 is "severe"
SSA: a validated 4-point categorical scale to assess the appearance of their GLs and FHLs at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles"
Measured: At Week 4
Response to treatment at Stage 2 for the LCL group
Measured by the composite response of ≥ 2-grade improvement ILA and SSA at maximum contraction on both sides of the lateral canthal lines (LCL) area:
ILA: a validated 4-point photographic scale to assess the severity and appearance of the LCLs at maximum frown and at rest where 0 is "none" and 3 is "severe"
SSA: a validated 4-point categorical scale to assess the appearance of their LCLs at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles"
Measured: At Week 4
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
Double Blind phase. Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
Measured: From the baseline to the end of the study (6 years, 5 months)
Percentage of participants with clinically significant Change from baseline in 12-lead Electrocardiogram (ECG) readings
Double Blind phase.
Measured: From the baseline to the end of the study (6 years, 5 months)
Percentage of participants with clinically significant change from baseline in facial and focused neurological/physical examination.
Double Blind phase. Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.
Measured: From the baseline to the end of the study (6 years, 5 months)

Secondary outcomes (20)

Percentage of participants response to treatment.
For all stages. Measured by the composite response of ≥ 2-grade improvement on ILA and SSA for each concerned facial area in each respective stage (GL/LCL/FHL)
ILA: a validated 4-point photographic scale to assess the severity and appearance of the GLs/LCLs/FHLs in each respective stage at maximum frown and at rest where 0 is "no lines are noticeable" and 3 is "lines are extremely pronounced"
SSA: a validated 4-point categorical scale to assess the appearance of their GLs/LCLs/FHLs in each respective stage at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles"
Measured: From the baseline to the end of the study (up to 6 years, 5 months)
Percentage of participants response to treatment as measured by the reduction of ≥1 grade on the ILA at maximum contraction for each concerned facial area
For all stages.
Measured: From the baseline to the end of the study (up to 6 years, 5 months)
Percentage of participants with clinically significant change from baseline in facial and focused neurological/physical examination
For all stages. Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.
Measured: From the baseline to the end of the study (up to 6 years, 5 months)
Percentage of participants response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at rest on each facial area
For all stages
Measured: From the baseline to the end of the study (up to 6 years, 5 months)
Percentage of participants response to treatment as measured by the reduction of ≥1 grade on the SSA at maximum contraction for each concerned facial area
For all stages.
Measured: From the baseline to the end of the study (up to 6 years, 5 months)
Percentage of participants response to treatment as achieved by a score of "none" or "mild" as measured by the SSA at maximum contraction for each concerned facial area.
Stage 2 and Stage 3.
Measured: From the baseline to the end of the study (up to 6 years, 5 months)
Duration of treatment response based on ILA and SSA at maximum contraction for each concerned facial area
For all stages.
Measured: From the baseline to the end of the study (up to 6 years, 5 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)
Time to onset of treatment response based on subject diary cards to evaluate the appearance of their lines for each concerned facial area
For all stages.
Measured: From the baseline to the end of the study (up to 6 years, 5 months)
Satisfaction with facial appearance, measured by Facial Appearance Overall scale score on the Face-Q satisfaction scale
Stage 3. Face Q is a participant-reported outcome instrument to evaluate the experience and outcomes of aesthetic facial procedures from the participant's perspective. The Face Q instrument is composed of over 40 scales, covering four domains (Satisfaction with Facial Appearance, Health Related Quality of Life, Adverse Effects, and Process of Care).
Measured: From the baseline to the end of the study (up to 6 years, 5 months)
Satisfaction with facial appearance, measured by FACE-Q Short Form Facial Appearance scale score.
Stage 3. The FACE-Q Short Form Facial Appearance scale is a participant-reported outcome instrument. It asks how dissatisfied or satisfied the participant is with their upper facial lines (UFL) (GL+FHL+LCL). The scale ranges from very dissatisfied to very satisfied.
Measured: From the baseline to the end of the study (6 years, 5 months)
Incidence, severity and nature of treatment emergent adverse events (TEAEs)
All stages (except Stage 1/Step 1)
Measured: From baseline to the end of the study (up to 6 years, 5 months)
Incidence, severity and nature of serious adverse events (SAEs)
All stages (except Stage 1/Step 1)
Measured: From baseline to the end of the study (up to 6 years, 5 months)
Incidence, severity and nature of Adverse Events (AEs) (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs)
All stages (except Stage 1/Step 1)
Measured: From baseline to the end of the study (up to 6 years, 5 months)
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
All stages (except Stage 1/Step 1). Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
Measured: From baseline to the end of the study (6 years, 5 months)
Time between two consecutive injections
Stage 1/Step 3 .
Measured: From baseline to the end of the study (up to 6 years, 5 months)
Percentage of participants with binding antibodies to IPN10200
Stage 1/Step 2, Stage 1/Step 3, Stage 2, and Stage 3
Measured: At Week 4 , Week 24 and Week 36
Percentage of participants with neutralising antibodies to IPN10200
Stage 1/Step 2, Stage 1/Step 3, Stage 2, and Stage 3
Measured: At Week 4 , Week 24 and Week 36
Percentage of participants with binding antibodies to BontA
Stage 1/Step 2, Stage 1/Step 3, Stage 2, and Stage 3
Measured: At Week 4 , Week 24 and Week 36
Percentage of participants with neutralising antibodies to BontA
Stage 1/Step 2, Stage 1/Step 3, Stage 2, and Stage 3
Measured: At Week 4 , Week 24 and Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 202119 Aug 2027

First posted29 Mar 2021
Study start6 Apr 2021
Primary completion19 Aug 2027 (estimated)
Study completion19 Aug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Moderate to Severe 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 727 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04821089
Sponsor's protocol ID: D-FR-10200-002
Other IDs: 2024-512782-14-00
Acronym: LANTIC
Status last verified: Oct 2026
First submitted: 26 Mar 2021
Last updated: 6 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.