Phase
Condition
N/ATreatment
Placebo
IPN10200
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant should be male or female, ≥18 years of age inclusive at the time ofsigning the ICF.
Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the ILA usinga validated 4-point photographic scale.
Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the SSA usinga 4-point categorical scale.
Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at baseline, asassessed by the SLS.
For female participants: Contraceptive use by women should be consistent with localregulations regarding the methods of contraception for those participating inclinical studies.
Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the 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 area (e.g. acute acne lesions or ulcers).
A history of eyelid blepharoplasty or brow lift or any other upper facial surgerywithin the past 5 years.
A history of facial nerve palsy.
Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring orthick sebaceous skin.
Presence of any scars, piercings or tattoos (including micro blading of theeyebrows) in or around the treatment area that have occurred within 6 months priorto baseline, or which in the investigator's opinion, could interfere withevaluations.
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.).
Administration of any BoNT (other than the study intervention on baseline visit)into any site of the body and for any indication from 9 months prior to the firststudy visit until the end of the study.
Participants who have received IPN10200 in a previous study.
Use of medications that affect neuromuscular transmission (such as curare-likenondepolarising agents, lincosamides, polymyxins, anticholinesterases) within thepast 30 days prior to baseline are prohibited or a longer washout period of at leastfive half-lives might be required, as deemed appropriate by the investigator forlong-acting medications.
Use of aminoglycoside antibiotics within the past 30 days prior to baseline areprohibited. Note: Topical use apart from the area of injection would be acceptable.
Use of systemic retinoids within the past 30 days prior to baseline and planned useduring the study. Note: Topical retinoids are allowed other than in the areas thatwill be injected (upper facial area) at the discretion of the investigator.
Any prior treatment with permanent fillers, lifting threads, autologous fat orpermanent procedures in the upper face including the GL area.
Administration of any non-permanent injectables (such as hyaluronic acid, calciumhydroxylapatite, poly-L-Lactic acid or polymethyl-methacrylate) soft tissueaugmentation therapy in the GL region within 12 months prior to baseline.
Any prior facial treatment or aesthetic procedures to the upper face including photorejuvenation, vascular or pigment laser or microneedling within the 3 months priorto baseline.
Any prior facial treatment or aesthetic procedures to the upper face involving skinresurfacing (including dermabrasion, laser or whatever the interventional techniqueused) or chemical peel within the past 12 months prior to baseline.
Any planned cosmetic surgery or aesthetic procedures to the upper face during thestudy and/or any procedures to other parts of the face which in the investigator'sopinion, could interfere with evaluations during the study.
Any past surgery in the UFL area including GL.
Planned use of concomitant therapy which, in the investigator's opinion, wouldinterfere with the evaluation of the safety or efficacy of the study intervention.Therapy considered necessary for the participant's welfare may be given at thediscretion of the investigator. Note: If the permissibility of a specificmedication/treatment is in question, the medical monitor will be contacted.
Use of any experimental device within 30 days prior to baseline visit or use of anytreatment with an experimental drug within five times the documented terminalhalf-life of the respective drug or its metabolites or if the half-life is unknownwithin 30 days prior to the start of the study (prior to baseline visit) and duringthe conduct of the study.
Known positive for hepatitis B antigen, hepatitis C virus antibody or for humanimmunodeficiency virus 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 as determined by the investigator.
Known allergy or hypersensitivity to BoNT or any excipients of IPN10200.
A history of chronic or recreational drug abuse as assessed by the investigator.
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
Carruthers and Humphrey Cosmetic Medicine
Vancouver, British Columbia V5Z 4E1
CanadaActive - Recruiting
Pacific Dermaesthetics Inc.
Vancouver, British Columbia V6H4E1
CanadaSite Not Available
Institute of Cosmetic and Laser Surgery
Oakville, Ontario L6J 7W5
CanadaActive - Recruiting
Sweat clinics of canada
Toronto, Ontario M5R 3N8
CanadaActive - Recruiting
Bertucci MedSpa
Woodbridge, Ontario L4L 8E2
CanadaSite Not Available
Centre de Recherche Dermatologique de Quebec
Québec, Quebec G1V4X7
CanadaSite Not Available
Skin Wellness Dermatology - Homewood
Birmingham, Alabama 35209
United StatesActive - Recruiting
Advanced Research Associates
Glendale, Arizona 85308
United StatesActive - Recruiting
Avacare
Scottsdale, Arizona 85260
United StatesSite Not Available
Investigate MD, LLC
Scottsdale, Arizona 85260
United StatesActive - Recruiting
Ablon Skin Institute and Research Center
Manhattan Beach, California 90266
United StatesActive - Recruiting
Keith A. Marcus, MD Inc
Redondo Beach, California 90277
United StatesActive - Recruiting
West Dermatology
San Diego, California 92121
United StatesSite Not Available
Ava T. Shamban, M.D., Inc.
Santa Monica, California 90404
United StatesActive - Recruiting
Art of Skin MD
Solana Beach, California 92075
United StatesActive - Recruiting
Pacific Clinical Innovations Inc.
Vista, California 92083
United StatesActive - Recruiting
Skin Research Institute
Coral Gables, Florida 33146
United StatesActive - Recruiting
ICON Dermatology and Aesthetics
Bethesda, Maryland 20852
United StatesActive - Recruiting
Clinical Research Center of the Carolinas
Charleston, South Carolina 29407
United StatesSite Not Available
Westlake Dermatology & Cosmetic Surgery - Westlake
Austin, Texas 78746-5059
United StatesActive - Recruiting
Dermatology and Laser Surgery Center
Houston, Texas 77004
United StatesActive - Recruiting
Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research
Pflugerville, Texas 78660
United StatesActive - Recruiting
SkinDC
Arlington, Virginia 22209
United StatesActive - Recruiting

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