Diffusion Characteristics of Letibotulinumtoxin a in Comparison to Ona and Abo-Bonta

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hamburg University

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Not possible to specify

Decision date (initial)

2024-06-07

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Bioequivalence, Efficacy

The aim of this study is to investigate the spread of three approved botulinum toxin type A preparations with and without complex-forming proteins by measuring and comparing the size of the anhidrotic halos they produce after injection of equivalent doses in an identical volume into the forehead of patients.
The focus is on the comparison of letibotulinumtoxinA to onabotulinumtoxinA and abobotulinumtoxinA. In order to make an adequate change between different botulinum toxins possible, the diffusion surface of the toxins is of crucial importance.

Secondary objectives 1

1. Secondarily, tracking the areas of anhidrosis over a measured period of 6 months is important to ensure patient safety. In addition, the severity of wrinkles (no movement / maximum tension) is recorded over the specified period in a live evaluation and evaluation using standardized photography. Other points of importance: - Area under the curve (anhidrosis area) within a period of 6 months - Patient satisfaction - Eyebrow position

Conditions and MedDRA coding

Stable health without uncontrolled systemic diseases; Healthy skin testing area (forehead); Moderate to severe forehead wrinkling (in motion); Uniform sweating activity and no areas of anhidrosis (under standardized sweating conditions)

Study design 1 period

Regulatory references

Plan to share IPD

No

IPD plan description

undicided

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • Stable health without uncontrolled systemic diseases •Fitzpatrick Skin Type I – VI •Age 18-75 •BMI of 16-27 kg/m2 •Healthy skin testing area •Uniform sweating activity and no areas of anhidrosis under standardized sweating conditions •Moderate to severe wrinkling (in motion) Scale: Forehead Line Rating Scale •Female subjects of childbearing potential must present a negative pregnancy test and commit to using a highly effective method of contraception during the study

Exclusion criteria 1

1. • Asymmetrical forehead wrinkles • Active skin lesions/infections or irritations in the treatment area Past surgeries in the forehead area, including surgical removal of the corrugator, procerus or procerus or the supercilian depressor muscle, or a combination of these muscles, or scars in the forehead area, or such surgery is planned during the study • Prior dermal treatment of forehead within 6 months prior to inclusion Prior treatment (upper third of the face) with botulinum toxin of any serotype within 6 months prior to baseline, as well as botulinum toxin for any indication, except investigational drug during the study period • Known hypersensitivity to the study drug or its excipients • Any condition that could pose an increased risk to the subject due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, marked atrophy or weakness of the target muscles, or any other condition (at the discretion of the investigator) that could impair neuromuscular function or contraindicate botulinum toxin therapy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Maximum anhidrosis area; measured by the halo of anhidrosis

Secondary endpoints 1

1. Range of anhidrosis at all other measured time points; Wrinkle Thickness (No Movement / Maximum Tension) measured by Live Evaluation and Evaluation via Standardized Photography; Area under the curve (anhidrosis area) within a period of 6 months; Patient satisfaction; Eyebrow position

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hamburg University

Sponsor organisation

Hamburg University

Address

Papendamm 21, Rotherbaum Rotherbaum

City

Hamburg

Postcode

20146

Country

Germany

Scientific contact point

Organisation

Hamburg University

Contact name

Clinical trial information desc

Public contact point

Organisation

Hamburg University

Contact name

Clinical trial information desc

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications