New Orleans, Louisiana

Etre, Cosmetic Dermatology and Laser Center

Hyperhidrosis

MT10109L

Sofpironium Bromide

Allergan

Botanix Pharmaceuticals

Ipsen

Medytox

condition

allSponsorName

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

The purpose of this study is to assess the effectiveness and safety of a single dose of IPN10200 compared to placebo (double-blind phase) and how well and safely repeat doses of IPN10200 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 IPN10200 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 IPN10200 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 IPN10200 or placebo. In the open-label phase (rollover participants from double-blind), eligible participants may receive additional cycles of IPN10200. In the open-label phase (de novo participants), participants will receive IPN10200 in the first cycle and eligible participants may receive additional cycles of IPN10200. 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.

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

Etre, Cosmetic Dermatology and Laser Center | New Orleans, Louisiana

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Active trials

A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows (LAURITE 2)

Trial sponsors