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A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines
Sponsor: Ipsen
Summary
The purpose of this study is to assess the safety and efficacy profile of increasing doses of IPN10200 in comparison to placebo, with the aim to discover the doses(s) that offer the best efficacy/safety profile when used for the treatment of moderate to severe Upper Facial Lines. This study will be conducted in three stages. The full study (including all stages) will have a maximum 727 participants. Stage 1 (phase Ib \& II) * Step 1 (Phase Ib): a dose-escalation first-in-human step in participants with moderate to severe Glabellar Lines (GL) * Step 2 (Phase II): dose ranging step in participants with moderate to severe GL as compared with Dysport * Step 3 (Phase II): dose finding step in participants with moderate to severe GL as compared with Dysport, followed by an open label (OL) phase for the highest dose cohort to assess the long-term safety and efficacy of IPN10200. In the OL phase, participants may receive repeat administrations of IPN10200 for up to three additional cycles (up to four treatment cycles in total during the study). Stage 2 (phase II) - An evaluation of efficacy and safety of IPN10200 in one of the following regions: GL + forehead lines (FHL), forehead lines (FHL) or lateral canthal lines (LCL) Stage 3 (phase II) \- A safety and efficacy evaluation of IPN10200 in all three regions (GL, FHL and LCL)
Official title: A Phase Ib/II, Multicentre, Double-blind, Randomised, Placebo-controlled, Dose Escalation and Dose-finding Study to Evaluate the Safety and Efficacy of IPN10200 in Improving the Appearance of Moderate to Severe Upper Facial Lines in Adults
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
727
Start Date
2021-04-06
Completion Date
2027-03-05
Last Updated
2025-12-31
Healthy Volunteers
No
Conditions
Interventions
IPN10200
Stage 1: Several different doses will be administrated in a dose-escalation manner. One single injection will be injected locally into several sites across the glabellar region. Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions. Stage 3: One single injection will be injected locally into several sites across the upper facial area.
IPN10200 Placebo
Stage 1: One single injection of study intervention will be injected locally into several sites across the glabellar region. Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions. Stage 3: One single injection will be injected locally into several sites across the upper facial area.
Dysport
Single administration of study intervention in stage 1 / step 2 and 3 only
Locations (9)
MEDITI - Clinique Del Mar
Antibes, France
Aimed S.A.S
Lyon, France
Clinique de Chirurgie Esthétique Iéna
Paris, France
CRS Clinical Research Services Berlin GMBH
Berlin, Germany
Interdisciplinary Study Association
Berlin, Germany
ROSENPARK RESEARCH GmbH
Darmstadt, Germany
Privatpraxis Dr. Hilton & Partner
Düsseldorf, Germany
Fachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft
Hamburg, Germany
Dermatologische Gemeinschaftspraxis Blankenfelde-Mahlow
Mahlow, Germany