Phase
Condition
N/ATreatment
IPN10200
Dysport
IPN10200 Placebo
Clinical Study ID
Ages 18-65 Female
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 at maximum contraction at Baseline, as assessedby the ILA using a validated 4-point photographic scale.
Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessedby the SSA using a validated 4-point categorical scale.
Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at Baseline, asassessed by the SLS.
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 know positive SARS-CoV-2 test, or the presence of anyother condition (e.g. neuromuscular disorder or other disorder that could interferewith neuromuscular function)
Previous treatment with any BoNT serotype for Stage 1 / Step 1 or any recentreatment (within the past 6 months prior to baseline) with any BoNT serotype forStage 1 / Step 2.
Any prior treatment with permanent fillers in the upper face including the GL, FHLand LCL area.
Any prior treatment with long lasting dermal fillers in the upper face including theGL area within the past 3 years and/or skin abrasions/resurfacing (whatever theinterventional technic used) within the past 5 years, or photo rejuvenation orskin/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 interferewith the evaluation of the safety or efficacy of the study intervention, includingmedications affecting bleeding disorders (e.g. antiplatelet agents and/oranticoagulants given for treatment or prevention of cardiovascular/cerebrovasculardiseases).
Use of medications that affect neuromuscular transmission, such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases andaminoglycoside antibiotics, 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.
Study Design
Connect with a study center
MEDITI - Clinique Del Mar
Antibes,
FranceActive - Recruiting
Palais de Flore
Lyon,
FranceActive - Recruiting
Clinique de Chirurgie Esthétique Iéna
Paris,
FranceActive - Recruiting
CRS Clinical Research Services Berlin GMBH
Berlin, 13353
GermanyCompleted
Interdisciplinary Study Association
Berlin,
GermanySite Not Available
ROSENPARK RESEARCH GmbH
Darmstadt,
GermanyActive - Recruiting
Privatpraxis Dr. Hilton & Partner
Düsseldorf,
GermanyActive - Recruiting
Fachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft
Hamburg,
GermanyActive - Recruiting
Dermatologische Gemeinschaftspraxis Blankenfelde-Mahlow
Mahlow,
GermanyActive - Recruiting
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