CClinicalTrials.gg
RecruitingNCT07435428LAURITE 2Updated Sep 9, 2026

A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows

A Phase 3 interventional study of Corabotase and Placebo in Moderate to Severe Glabellar Lines, sponsored by Ipsen. Recruiting at 60 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Ipsen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the effectiveness and safety of a single dose of Corabotase (also known as IPN10200) compared to placebo (double-blind phase) and how well and safely repeat doses of Corabotase work over time (open-label phase) in adult participants with moderate to severe glabellar lines. Glabellar lines are wrinkle-like lines that appear between the eyebrows and can become more noticeable with age or repeated facial expressions. They may affect a person's appearance and confidence.

All participants in the double-blind phase will receive Corabotase or placebo during the first treatment cycle. De novo participants in the open-label phase will receive IPN10200 during the first treatment cycle. Some participants may receive additional treatment cycles with Corabotase depending on their eligibility.

There will be 3 periods in this study:

  • A screening period (up to 20 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre.
  • A treatment period where participants may receive up to 4 treatment cycles. In the double-blind phase, participants receive a single treatment of Corabotase or placebo. In the open-label phase (rollover participants from double-blind), eligible participants may receive additional cycles of Corabotase . In the open-label phase (de novo participants), participants will receive Corabotase in the first cycle and eligible participants may receive additional cycles of Corabotase. Requires multiple visits during the first month followed by 1 visit every month.
  • A follow-up period (24 weeks) after the last injection where participants' health will be monitored.

Participants will undergo health measurements and observation, including blood sampling, physical examinations, clinical evaluations and electrocardiograms (ECG: recording of the electrical activity of heart). They will also be asked to fill in questionnaires and keep a diary.

Each participant will be in this study for up to 107 weeks. Participants may withdraw consent to participate at any time.

02

Conditions studied

  • Moderate to Severe Glabellar Lines
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant should be male or female, ≥18 years of age at the time of signing the informed consent.
  • Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the ILA using a validated 4-point photographic scale.
  • Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the SSA using a 4-point categorical scale.
  • Are 'dissatisfied' or 'very dissatisfied' with their GLs at baseline, as assessed by the SLS score.
  • For female participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Participant has both the time and 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.

Exclusion criteria

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 surgery within the past 5 years.
  • A history of facial nerve palsy.
  • Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring or thick 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 with regard to exposure to BoNT of any serotype (i.e. myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.).
  • Presence of any scars, piercings, or tattoos (including microblading of the eyebrows) in or around the treatment area that have occurred within 6 months prior to baseline, or which in the investigator's opinion, could interfere with evaluations.
  • Administration of any BoNT (other than the study intervention) into any site of the body and for any indication from 9 months prior to the first study visit until the end of the study.
  • Treatment with IPN10200 in any prior study.
  • Use of medications that affect neuromuscular transmission (such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases) within the past 30 days prior to baseline is prohibited or a longer washout period of at least five half lives might be required, as deemed appropriate by the investigator for long-acting medications.
  • Use of aminoglycoside antibiotics within the past 30 days prior to baseline are prohibited. 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 use during the study. Note: Topical retinoids are allowed other than in the areas that will be injected (upper facial area) at the discretion of the investigator.
  • Any prior treatment with permanent fillers, lifting threads, autologous fat or permanent procedures in the upper face including the GL area.
  • Administration of any nonpermanent injectables (such as hyaluronic acid, calcium hydroxylapatite, poly-L-lactic acid or polymethyl-methacrylate) for soft tissue augmentation 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 prior to baseline.
  • Any prior facial treatment or aesthetic procedures to the upper face involving skin resurfacing (including dermabrasion, laser, or whatever the interventional technique used) or chemical peel within the past 12 months prior to baseline.
  • Any planned cosmetic surgery or aesthetic procedures to the upper face during the study and/or any procedures to other parts of the face which in the investigator's opinion, 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, 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. Note: If the permissibility of a specific medication/treatment is in question, the medical monitor will be contacted.
  • 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 half-life 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 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 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 would be harmful for the participant to be entered into the study or continue participation.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,300 participants (estimated)

Study arms

  • Experimental
    Corabotase group

    Participants will receive Corabotase via injection into the selected muscles on Day 1 of the double-blind (DB) phase. Participants who are new to treatment (the de novo phase) will receive Corabotase via injections into the selected muscles during the first and subsequent treatment cycles.

    Biological: Corabotase

  • Placebo comparator
    Placebo group

    Participants will receive placebo via injection into the selected muscles on Day 1 of the DB phase.

    Biological: Placebo

Interventions

  • BiologicalCorabotase

    A single vial of lyophilised powder for solution for injection will be injected locally into several sites across the glabellar region.

    Also known as: IPN10200

  • BiologicalPlacebo

    A single vial of lyophilised powder for solution, containing excipients without active substance, will be injected locally into several sites across the glabellar region.

05

What researchers measure

Primary outcomes

  1. For North America: Percentage of participants responding to treatment

    Measured by the multi-component response of ≥2-grade improvement and a score of 'None' or 'Mild' on Investigator's Live Assessment (ILA) and Subject's Self-Assessment (SSA) at maximum frown. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe." SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."

    Time frame: At week 4

  2. For EU and ROW: Percentage of participants responding to treatment as measured by ≥2-grades improvement on the ILA at maximum frown

    ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

    Time frame: From baseline to week 4

Secondary outcomes

  1. For Double Blind (DB) phase: For North America: Percentage of participants responding to treatment

    Measured by the composite response of ≥2-grade improvement and a score of 'None' or 'Mild' on ILA and SSAat maximum frown. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe." SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."

    Time frame: At week 24

  2. For DB phase: Percentage participants responding to treatment as measured by a score of "None" or "Mild on ILA at maximum frown

    ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

    Time frame: At each post-treatment visit except week 4 (For EU and ROW) and week 24 (for United States) up to week 24

  3. For DB phase: Percentage of participants responding to treatment as measured by a score of "None" or "Mild on SSA at maximum frown

    SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."

    Time frame: At week 24

  4. For DB phase: For all regions except United States: Percentage of participants satisfied with their facial appearance after the treatment as measured by a score of 'Very Satisfied' or 'Satisfied' on Subject's Level of Satisfaction (SLS)

    SLS: a validated 4-point categorical scale used to assess satisfaction with the appearance of glabellar lines, where grade 0 = "Very satisfied," grade 1 = "Satisfied," grade 2 = "Dissatisfied," and grade 3 = "Very dissatisfied."

    Time frame: At week 4 and week 24

  5. For DB and Open Label (OL) phase: Percentage of participants responding to treatment as measured by a score of "None" or "Mild" on ILA at maximum frown

    ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

    Time frame: DB phase: From baseline to each post-treatment visit until week 52 (except week 4 (for EU and all other regions) and week 24); OL phase: From baseline to each post-treatment visit until week 104

  6. For DB and OL phase: Percentage of participants responding to treatment as measured by a score of "None" or "Mild" on SSA at maximum frown

    SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."

    Time frame: DB phase: From baseline to each post-treatment visit until week 52 (except week 24); OL phase: From baseline to each post-treatment visit until week 104

  7. For DB and OL phase: Percentage of participants responding to treatment

    Measured by the multi-component response of ≥2-grade improvement and a score of 'None' or 'Mild' on ILA and SSA at maximum frown. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe." SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."

    Time frame: From baseline to each post-treatment visit until week 52 (except week 4 and week 24 [for North America]); OL phase: From baseline to each post-treatment visit until week 104

  8. For DB and OL phase: Percentage of participants responding to treatment as measured by the response of ≥2-grade improvement and a score of 'None' or 'Mild' on ILA at maximum frown

    ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

    Time frame: From baseline to each post-treatment visit until week 52 (except week 4 and week 24 [for North America]); OL phase: From baseline to each post-treatment visit until week 104

  9. For DB and OL phase: Percentage of participants responding to treatment as measured by the response of ≥2-grade improvement and a score of 'None' or 'Mild' on SSA at maximum frown

    SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."

    Time frame: DB phase: From baseline to each post-treatment visit until week 52; OL phase: From baseline to each post-treatment visit until week 104

  10. For DB and OL phase: Percentage of participants responding to treatment as measured by the response of ≥1-grade improvement on ILA at maximum frown

    ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

    Time frame: DB phase: From baseline to each post-treatment visit until week 52; OL phase: From baseline to each post-treatment visit until week 104

  11. For DB and OL phase: Percentage of participants responding to treatment as measured by the response of ≥1-grade improvement on SSA at maximum frown

    SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles."

    Time frame: From baseline to each post-treatment visit until week 52; OL phase: From baseline to each post-treatment visit until week 104

  12. For DB and OL phase: Percentage of participants responding to treatment as measured by the response of ≥1-grade improvement on ILA at rest

    LA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at rest, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

    Time frame: DB phase: From baseline to each post-treatment visit until week 52; OL phase: From baseline to each post-treatment visit until week 104

  13. For DB and OL phase: Percentage of participants satisfied with their facial appearance after the treatment as measured by a score of 'Very Satisfied' or 'Satisfied' on SLS

    SLS: a validated 4-point categorical scale used to assess satisfaction with the appearance of glabellar lines, where grade 0 = "Very satisfied," grade 1 = "Satisfied," grade 2 = "Dissatisfied," and grade 3 = "Very dissatisfied."

    Time frame: DB phase: From baseline to each post-treatment visit until week 52 (except week 4 and week 24 [for United States]); OL phase: From baseline to each post-treatment visit until week 104

  14. For DB and OL phase: Percentage of participants with change from baseline in ageing appearance, as measured by visual analogue scale (VAS) on FACE-Q

    FACE-Q Ageing Appearance VAS: a validated visual analogue scale used to assess participants' perceived age compared with their actual age. Participants respond to the question, "How many years younger or older do you think you look compared with your actual age?" by selecting a point on the scale, where negative values indicate years younger and positive values indicate years older

    Time frame: DB phase: For each post-treatment visit until end of DB phase (week 52); OL phase: From baseline to all visits until end of OL phase (week 104)

  15. For DB and OL phase: Percentage of participants with an improvement of at least 10 points from baseline on the Rasch Transformed Score of the FACE-Q Psychological Function Scale

    FACE-Q Psychological Function Scale: a validated 4-point categorical scale used to assess participants' psychological well-being. The scale consists of statements about how participants feel about themselves, with responses indicating the level of agreement on a 4-point scale ranging from "definitely disagree" to "definitely agree."

    Time frame: DB phase: From baseline to all visits until end of DB phase (week 52) (except at week 4 for EU); OL phase: From baseline to all visits until end of OL phase (week 104)

  16. For DB phase: Time to onset of treatment response based on participant diary to evaluate the appearance of their lines

    Participants record in a diary whether they notice an improvement in the appearance of their glabellar lines, with responses captured as Yes/No.

    Time frame: From baseline and daily from Day 1 to Day 8 (week 1).

  17. For OL phase: Time between two consecutive injections

    Time frame: OL phase: 24 weeks after the previous injections until week 80

  18. For DB phase: Time taken for a responder to re-exhibit a severity grade of 'Moderate' or 'Severe' on the ILA at maximum frown

    Responder is defined as having a score of 'None' or 'Mild' on the ILA. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at rest, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."

    Time frame: At all timepoints post-injection until end of DB phase (week 52).

  19. For DB and OL phase: Percentage of participants experiencing treatment emergent adverse events (TEAEs).

    An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began.

    Time frame: DB phase: At all timepoints post-injection until end of DB phase (week 52); OL phase: At all timepoints post-injection until end of OL phase (week 104)

  20. For DB and OL phase: Percentage of participants experiencing serious adverse events (SAEs).

    A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or is considered medically significant by the investigator.

    Time frame: DB phase: At all timepoints post-injection until end of DB phase (week 52); OL phase: At all timepoints post-injection until OL phase (week 104)

  21. For DB and OL phase: Percentage of participants experiencing Adverse Events (AEs) (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs).

    An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began. Adverse events of special interest (AESIs) are AEs that may not be serious but are of special importance to a particular drug or class of drugs.

    Time frame: At all timepoints post-injection until end of DB phase (week 52); OL phase: At all timepoints post-injection until OL phase (week 104)

  22. For DB and OL phase: Percentage of participants with clinically significant changes from baseline in vital signs.

    Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.

    Time frame: At all timepoints post-injection until end of DB phase (week 52); OL phase: At all timepoints post-injection until OL phase (week 104)

  23. For DB and OL phase: Percentage of participants with clinically significant Change from baseline in 12-lead Electrocardiogram (ECG) readings

    Time frame: DB phase: At baseline, week 4 and 52; OL phase: Up to week 104

  24. For DB and OL phase: Percentage of participants with clinically significant change from baseline in facial and focused neurological/physical examination

    Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.

    Time frame: DB phase: At all timepoints post-injection until end of DB phase (week 52); OL phase: At all timepoints post-injection until OL phase (week 104)

  25. For DB and OL phase: Percentage of participants with binding antibodies to IPN10200

    Time frame: DB phase: At screening, week 4, 12, 24, 36, 52, & EoS; OL phase: At baseline, week 4, 12, 24, 36, 52 of each cycle & EoS. Cycle 1 is up to 1 year for DB & 18 months for OL, Cycle 2 up to 1 year 1 month, Cycle 3 up to 8 months, and Cycle 4 up to 6 months

  26. For DB and OL phase: Percentage of participants with neutralising antibodies to IPN10200

    Time frame: DB phase: At screening, week 4, 12, 24, 36, 52, & EoS; OL phase: At baseline, week 4, 12, 24, 36, 52 of each cycle & EoS. Cycle 1 is up to 1 year for DB & 18 months for OL, Cycle 2 up to 1 year 1 month, Cycle 3 up to 8 months, and Cycle 4 up to 6 months

06

Study locations

40 of 60 sites recruiting
  • Rivkin Westside Aesthetics
    Los Angeles, California 90025, United States
    Not yet recruiting
  • Clinical Testing of Beverly Hills
    Los Angeles, California 91436, United States
    Recruiting
  • Eye Research Foundation
    Newport Beach, California 92663, United States
    Recruiting
  • Steve Yoelin MD Medical Associates Inc
    Newport Beach, California 92663, United States
    Recruiting
  • Skin and Beauty Center
    Pasadena, California 91105, United States
    Recruiting
  • Dermatology Cosmetic Laser Medical Associates of La Jolla Inc.
    San Diego, California 92121, United States
    Not yet recruiting
  • Southern California Dermatology, Inc.
    Santa Ana, California 92701, United States
    Not yet recruiting
  • DMR Research, PLLC
    Westport, Connecticut 06880, United States
    Recruiting
  • Center for Dermatology and Dermatologic Surgery
    Washington D.C., District of Columbia 20037, United States
    Not yet recruiting
  • Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura
    Aventura, Florida 33180, United States
    Recruiting
  • Weinkle Dermatology
    Bradenton, Florida 34209, United States
    Recruiting
  • Skin Research Institute
    Coral Gables, Florida 33146, United States
    Not yet recruiting
  • Miami Dermatology & Laser Research
    Miami, Florida 33133, United States
    Recruiting
  • Kavali Plastic Surgery and Skin Renewal Center
    Atlanta, Georgia 30328, United States
    Recruiting
  • DeNova Research
    Chicago, Illinois 60610, United States
    Recruiting
  • Chicago Cosmetic and Dermatologic Research
    Chicago, Illinois 60654-5826, United States
    Recruiting
  • Advanced Dermatology, A Forefront Dermatology Practice
    Lincolnshire, Illinois 60069, United States
    Not yet recruiting
  • LASSI - Laser and Skin Surgery Center of Indiana
    Indianapolis, Indiana 46260, United States
    Recruiting
  • Coleman Center For Cosmetic Dermatologic Surgery
    Metairie, Louisiana 70006, United States
    Not yet recruiting
  • DelRicht Research
    New Orleans, Louisiana 70115, United States
    Recruiting
  • Etre, Cosmetic Dermatology and Laser Center
    New Orleans, Louisiana 70130, United States
    Recruiting
  • Maryland Laser, Skin, & Vein Institute, LLC (MDLSV)
    Hunt Valley, Maryland 21030, United States
    Recruiting
  • Lawrence J. Green, MD. LLC
    Rockville, Maryland 20850, United States
    Recruiting
  • SkinCare Physicians
    Chestnut Hill, Massachusetts 02467, United States
    Recruiting
  • Michigan Center for Research Company
    Clarkston, Michigan 48346, United States
    Recruiting
  • Skin Specialists PC dba Schlessinger MD
    Omaha, Nebraska 68144, United States
    Recruiting
  • StracSkin
    Portsmouth, New Hampshire 03801, United States
    Recruiting
  • Rejuva Center at Williams
    Latham, New York 12110, United States
    Recruiting
  • The Center for Dermatology, Cosmetic & Laser Surgery
    Mount Kisco, New York 10549, United States
    Recruiting
  • Luxurgery
    New York, New York 10021, United States
    Recruiting
  • Dr. Z. Paul Lorenc MD, Office Of
    New York, New York 10028, United States
    Recruiting
  • Skin Search Of Rochester, Inc.
    Rochester, New York 14623, United States
    Recruiting
  • Rochester Dermatologic Surgery, P.C.
    Victor, New York 14561, United States
    Not yet recruiting
  • Aesthetic Solutions P.A.
    Chapel Hill, North Carolina 27517, United States
    Recruiting
  • Dermatology, Laser & Vein Specialists of the Carolinas (DLVSC) - Charlotte Office
    Charlotte, North Carolina 28207, United States
    Recruiting
  • Nash Research Group, LLC
    Powell, Ohio 43065, United States
    Recruiting
  • Oregon Dermatology and Research Center
    Portland, Oregon 97210, United States
    Recruiting
  • Paddington Testing Company
    Philadelphia, Pennsylvania 19103, United States
    Recruiting
  • Brian S. Biesman MD, PLLC
    Nashville, Tennessee 37203, United States
    Recruiting
  • Tennessee Clinical Research Center
    Nashville, Tennessee 37215, United States
    Recruiting
  • Center for Clinical Studies
    Webster, Texas 77598, United States
    Not yet recruiting
  • Sas Aimed
    Lyon, 69006, France
    Not yet recruiting
  • Institut Cyrnos
    Nice, 6000, France
    Not yet recruiting
  • Thinkin SAS
    Paris, 75016, France
    Not yet recruiting
  • Rosenpark Research GmbH
    Darmstadt, 64283, Germany
    Not yet recruiting
  • Privatpraxis Dr. Hilton & Partner
    Düsseldorf, 40212, Germany
    Not yet recruiting
  • Universitaet Hamburg - Institut fuer Biochemie und Molekularbiologie
    Hamburg, 20146, Germany
    Not yet recruiting
  • Derma Science GmbH
    Hamburg, 22609, Germany
    Not yet recruiting
  • Noahklinik- Klinik fuer Plastische Chirurgie
    Kassel, 34117, Germany
    Not yet recruiting
  • Dermatologische Gemeinschaftspraxis
    Mahlow, 15831, Germany
    Not yet recruiting
  • Skin Concept - Private Dermatology Practice
    München, 80333, Germany
    Not yet recruiting
  • Haut- und Lasercentrum Potsdam
    Potsdam, 14467, Germany
    Not yet recruiting
  • Akihabara Skin Clinic
    Chiyoda-ku, 101-0021, Japan
    Recruiting
  • Medical Corporation Chiseikai - Tokyo Center Clinic
    Chūōku, 103-0027, Japan
    Recruiting
  • Josui Dermatology Clinic
    Fukuoka, 810-0022, Japan
    Recruiting
  • Clinica BellaForma
    Minatoku, 107-0052, Japan
    Recruiting
  • Forest Palace Dermatology Clinic
    Nerima-ku, 177-0041, Japan
    Recruiting
  • Kume Derma Clinic
    Sakaishi, 593-8324, Japan
    Recruiting
  • Kotoni Tower Dermatology and Plastic Surgery
    Sapporo, 063-0812, Japan
    Recruiting
  • Yoshikawa Skin Clinic
    Takatsuki-shi, 569-0824, Japan
    Recruiting
07

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07435428
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Feb 18, 2026
Primary completion
Dec 15, 2026 (estimated)
Completion
Oct 1, 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Ipsen Recruitment Enquiries
Contact
clinical.trials@ipsen.com
see email

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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