Simultaneous treatment of upper and two thirds of the face withIncobotulinumtoxinA applied intradermally (Interventional Phase II)

Phase 1

• Conditions: Skin perception after intradermal application of INCOBOTULINUMTOXINA within upper and midface; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-001318-39-DE
• Lead Sponsor: Prof. Dr. Martina Kerscher, University of Hamburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-09
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

40 female patients, aged 30 – 50 (premenopausal) being dissatisfied
with skin quality (suffering from increased skin surface roughness,
dilated pores, uneven skin surface)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Additional to Botulinum type A exclusion criteria: no HA, PRP or other
autologous treatment, no Calciumhydroxylapatite (CaHA), no
radiofrequency, Ultherapy in relevant treatment area within last 12
months. Not pregnant, not breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified