Phase
Condition
N/ATreatment
IPN10200
Dysport
IPN10200 Placebo
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be 18 to 65 years of age inclusive, at the time of signing theinformed 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 moderateto 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-pointphotographic scale).
Moderate or severe (Grade 2 or 3) FHL (Stage 3) at maximum contraction and moderateto severe GL at maximum contraction at Baseline and moderate to severe (Grade 2 or
- 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 moderateto 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-pointphotographic scale.
Moderate or severe (Grade 2 or 3) FHL (Stage 3) at maximum contraction and moderateto 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-pointphotographic scale.
Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines (Stages 1 to 3) atBaseline, as assessed by the SLS.
Male and female participants (only female for Stage 1/Step 1). Contraceptive use bymen or women should be consistent with local regulations regarding the methods ofcontraception for those participating in clinical studies
Capable of giving signed informed consent includes compliance with the requirementsand 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 withstudy instructions.
Does not reside in an institution by administrative or court order.
Is not a sponsor employee or clinical research unit personnel directly affiliatedwith the study or is not an immediate family member. Immediate family is defined asa spouse, parent, child or sibling whether biological or legally adopted.
Exclusion
Exclusion Criteria:
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, orthick sebaceous skin.
Any known medical condition that may put the participant at increased risk in regardto 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 presenceof any other condition (e.g. neuromuscular disorder or other disorder that couldinterfere with neuromuscular function)
Previous treatment with any BoNT serotype for Stage 1 / Step 1 or any recenttreatment (within the past 9 months prior to baseline) with any BoNT serotype forStage 1 / Step 2, Stage 1/Step 3, Stages 2 and 3. Participants treated in earlierStages/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, FHLand LCL area.
Any prior treatment with long lasting dermal fillers or any permanent procedures inthe upper face inclusion the GL area within the past 3 years and/or skinabrasions/resurfacing (whatever the interventional technic used) within the past 5years, or photo rejuvenation or skin/vascular laser intervention within the 12months prior to Baseline.
Any planned facial cosmetic surgery during the study.
Use of concomitant therapy which, in the investigator's opinion, would interferewith the evaluation of the safety or efficacy of the study intervention. Therapyconsidered necessary for the participant's welfare may be given at the discretion ofthe investigator.
Use of medications that affect neuromuscular transmission, such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases, aminoglycosideantibiotics and systemic retinoids, within the past 30 days prior to Baseline.
Use of any experimental device within 30 days or use of any treatment with anexperimental drug within five times the documented terminal half-life of therespective drug or its metabolites or if the halflife is unknown within 30 daysprior to the start of the study (prior to Baseline) and during the conduct of thestudy.
Known positive for hepatitis B antigen, or hepatitis C virus antibody, or for humanimmunodeficiency virus (HIV) or a diagnosis of acquired immunodeficiency syndrome.
Clinically diagnosed significant anxiety disorder, or any other significantpsychiatric disorder (e.g. depression) that might interfere with the participant'sparticipation in the study
An inability to substantially lessen GL and/or horizontal forehead rhytids even byphysically spreading them apart as determined by the investigator.
Known allergy or hypersensitivity to BoNT or any excipients of IPN10200 orDusport/Azzalure, or allergy to cow's milk protein.
A history of drug or alcohol abuse
Pregnant women, nursing women, premenopausal women or women of childbearingpotential not willing to practice a highly effective form of contraception method
Male participants who are not vasectomized and who have female partners ofchildbearing potential and are not willing to use condoms with spermicide throughoutstudy participation.
Any uncontrolled systemic disease or other significant medical condition which wouldbe harmful for the participant to be entered into the study or continueparticipation.
Study Design
Connect with a study center
MEDITI - Clinique Del Mar
Antibes,
FranceSite Not Available
MEDITI - Clinique Del Mar
Antibes 3037456,
FranceActive - Recruiting
Palais de Flore
Lyon,
FranceSite Not Available
Aimed S.A.S
Lyon 2996944,
FranceActive - Recruiting
Clinique de Chirurgie Esthétique Iéna
Paris,
FranceSite Not Available
Clinique de Chirurgie Esthétique Iéna
Paris 2988507,
FranceActive - Recruiting
CRS Clinical Research Services Berlin GMBH
Berlin, 13353
GermanyCompleted
Interdisciplinary Study Association
Berlin,
GermanySite Not Available
CRS Clinical Research Services Berlin GMBH
Berlin 2950159, 13353
GermanyCompleted
Interdisciplinary Study Association
Berlin 2950159,
GermanySite Not Available
ROSENPARK RESEARCH GmbH
Darmstadt,
GermanySite Not Available
ROSENPARK RESEARCH GmbH
Darmstadt 2938913,
GermanyActive - Recruiting
Privatpraxis Dr. Hilton & Partner
Düsseldorf,
GermanySite Not Available
Privatpraxis Dr. Hilton & Partner
Düsseldorf 2934246,
GermanyActive - Recruiting
Fachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft
Hamburg,
GermanySite Not Available
Fachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft
Hamburg 2911298,
GermanyActive - Recruiting
Dermatologische Gemeinschaftspraxis Blankenfelde-Mahlow
Mahlow,
GermanySite Not Available
Dermatologische Gemeinschaftspraxis Blankenfelde-Mahlow
Mahlow 2874461,
GermanyActive - Recruiting

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