Phase
Condition
N/ATreatment
IPN10200
Placebo
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 at the time of signing theinformed consent.
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.
Are 'dissatisfied' or 'very dissatisfied' with their GLs at baseline, as assessed bythe SLS score.
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 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.
Closed-angle glaucoma or a predisposition to it (for Japan only).
Any known medical condition that may put the participant at increased risk withregard to exposure to BoNT of any serotype (i.e. myasthenia gravis, Eaton-Lambertsyndrome, amyotrophic lateral sclerosis, etc.).
Presence of any scars, piercings, or tattoos (including microblading 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.
Administration of any BoNT (other than the study intervention) into any site of thebody and for any indication from 9 months prior to the first study visit until theend of the study.
Treatment with IPN10200 in any prior study.
Use of medications that affect neuromuscular transmission (such as curare-likenondepolarising agents, lincosamides, polymyxins, anticholinesterases) within thepast 30 days prior to baseline is 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 nonpermanent injectables (such as hyaluronic acid, calciumhydroxylapatite, poly-L-lactic acid or polymethyl-methacrylate) for soft tissueaugmentation therapy in the GL region within 12 months prior to baseline.
Any prior facial treatment or aesthetic procedures to the upper face includingphotorejuvenation, vascular or pigment laser or microneedling within the 3 monthsprior to 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 upper facial line 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 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 half-life 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 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
Sas Aimed
Lyon, 69006
FranceSite Not Available
Institut Cyrnos
Nice, 6000
FranceSite Not Available
Thinkin SAS
Paris, 75016
FranceSite Not Available
Rosenpark Research GmbH
Darmstadt, 64283
GermanySite Not Available
Privatpraxis Dr. Hilton & Partner
Düsseldorf, 40212
GermanySite Not Available
Derma Science GmbH
Hamburg, 22609
GermanySite Not Available
Universitaet Hamburg - Institut fuer Biochemie und Molekularbiologie
Hamburg, 20146
GermanySite Not Available
Noahklinik- Klinik fuer Plastische Chirurgie
Kassel, 34117
GermanySite Not Available
Dermatologische Gemeinschaftspraxis
Mahlow, 15831
GermanySite Not Available
Skin Concept - Private Dermatology Practice
München, 80333
GermanySite Not Available
Haut- und Lasercentrum Potsdam
Potsdam, 14467
GermanySite Not Available
Akihabara Skin Clinic
Chiyoda-ku, 101-0021
JapanActive - Recruiting
Medical Corporation Chiseikai - Tokyo Center Clinic
Chūōku, 103-0027
JapanActive - Recruiting
Josui Dermatology Clinic
Fukuoka, 810-0022
JapanActive - Recruiting
Clinica BellaForma
Minatoku, 107-0052
JapanActive - Recruiting
Forest Palace Dermatology Clinic
Nerima-ku, 177-0041
JapanActive - Recruiting
Kume Derma Clinic
Sakaishi, 593-8324
JapanActive - Recruiting
Kotoni Tower Dermatology and Plastic Surgery
Sapporo, 063-0812
JapanActive - Recruiting
Yoshikawa Skin Clinic
Takatsuki-shi, 569-0824
JapanActive - Recruiting
Clinical Testing of Beverly Hills
Los Angeles, California 91436
United StatesActive - Recruiting
Rivkin Westside Aesthetics
Los Angeles, California 90025
United StatesSite Not Available
Eye Research Foundation
Newport Beach, California 92663
United StatesActive - Recruiting
Steve Yoelin MD Medical Associates Inc
Newport Beach, California 92663
United StatesActive - Recruiting
Skin and Beauty Center
Pasadena, California 91105
United StatesActive - Recruiting
Dermatology Cosmetic Laser Medical Associates of La Jolla Inc.
San Diego, California 92121
United StatesSite Not Available
Southern California Dermatology, Inc.
Santa Ana, California 92701
United StatesSite Not Available
DMR Research, PLLC
Westport, Connecticut 06880
United StatesActive - Recruiting
Center for Dermatology and Dermatologic Surgery
Washington D.C., District of Columbia 20037
United StatesSite Not Available
Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura
Aventura, Florida 33180
United StatesActive - Recruiting
Weinkle Dermatology
Bradenton, Florida 34209
United StatesActive - Recruiting
Skin Research Institute
Coral Gables, Florida 33146
United StatesSite Not Available
Miami Dermatology & Laser Research
Miami, Florida 33133
United StatesActive - Recruiting
Kavali Plastic Surgery and Skin Renewal Center
Atlanta, Georgia 30328
United StatesActive - Recruiting
Chicago Cosmetic and Dermatologic Research
Chicago, Illinois 60654-5826
United StatesActive - Recruiting
DeNova Research
Chicago, Illinois 60610
United StatesActive - Recruiting
Advanced Dermatology, A Forefront Dermatology Practice
Lincolnshire, Illinois 60069
United StatesSite Not Available
LASSI - Laser and Skin Surgery Center of Indiana
Indianapolis, Indiana 46260
United StatesActive - Recruiting
Coleman Center For Cosmetic Dermatologic Surgery
Metairie, Louisiana 70006
United StatesSite Not Available
DelRicht Research
New Orleans, Louisiana 70115
United StatesActive - Recruiting
Etre, Cosmetic Dermatology and Laser Center
New Orleans, Louisiana 70130
United StatesActive - Recruiting
Maryland Laser, Skin, & Vein Institute, LLC (MDLSV)
Hunt Valley, Maryland 21030
United StatesActive - Recruiting
Lawrence J. Green, MD. LLC
Rockville, Maryland 20850
United StatesActive - Recruiting
SkinCare Physicians
Chestnut Hill, Massachusetts 02467
United StatesActive - Recruiting
Michigan Center for Research Company
Clarkston, Michigan 48346
United StatesActive - Recruiting
Skin Specialists PC dba Schlessinger MD
Omaha, Nebraska 68144
United StatesActive - Recruiting
StracSkin
Portsmouth, New Hampshire 03801
United StatesActive - Recruiting
Rejuva Center at Williams
Latham, New York 12110
United StatesActive - Recruiting
The Center for Dermatology, Cosmetic & Laser Surgery
Mount Kisco, New York 10549
United StatesActive - Recruiting
Dr. Z. Paul Lorenc MD, Office Of
New York, New York 10028
United StatesActive - Recruiting
Luxurgery
New York, New York 10021
United StatesActive - Recruiting
Skin Search Of Rochester, Inc.
Rochester, New York 14623
United StatesActive - Recruiting
Rochester Dermatologic Surgery, P.C.
Victor, New York 14561
United StatesSite Not Available
Aesthetic Solutions P.A.
Chapel Hill, North Carolina 27517
United StatesActive - Recruiting
Dermatology, Laser & Vein Specialists of the Carolinas (DLVSC) - Charlotte Office
Charlotte, North Carolina 28207
United StatesActive - Recruiting
Nash Research Group, LLC
Powell, Ohio 43065
United StatesActive - Recruiting
Oregon Dermatology and Research Center
Portland, Oregon 97210
United StatesActive - Recruiting
Paddington Testing Company
Philadelphia, Pennsylvania 19103
United StatesActive - Recruiting
Brian S. Biesman MD, PLLC
Nashville, Tennessee 37203
United StatesActive - Recruiting
Tennessee Clinical Research Center
Nashville, Tennessee 37215
United StatesActive - Recruiting
Center for Clinical Studies
Webster, Texas 77598
United StatesSite Not Available

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