Skin perception after intradermal application of INCOBOTULINUMTOXIN A within upper and midface
Conditions
Interventions
Trade Name: Bocouture
Product Name: Bocouture
Product Code: Bocouture
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Botulinum-Toxin A for injection
Other descriptive name
Sponsors
Prof. Dr. Martina Kerscher, University of Hamburg
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To obtain first data on changes in skin perception after intradermal injection of IncobotulinumtoxinA into upper and mid face . Change in skin surface roughness before and 4 weeks after intradermal injection of IncobotulinumtoxinA (primary efficacy criterion).;Secondary Objective: Change in skin physiology (pH, TEWL, Sebumetry, Cutometry, Corneometry), GICS, Skin Quality Assessment, patient satisfaction after intradermal injection of IncobotulinumtoxinA (time points: 4 weeks, 8 weeks, 12 and 16 weeks) after injection (secondary efficacy criteria) and skin surface roughness after 8, 12 and 16 weeks);Primary end point(s): Change in skin surface roughness parameters (Skin smoothness (SEsm), Skin roughness (SEr), Scaly / Scaliness (SEsc) and Folds / wrinkles (SEw) at day 30 compared to base-line after intradermal injection of IncobotulinumtoxinA in the upper two thirds of the face by using Visioscan® VC 20plus;Timepoint(s) of evaluation of this end point: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in skin surface roughness parameters (Skin smoothness (SEsm), Skin roughness (SEr), Scaly / Scaliness (SEsc) and Folds / wrinkles (SEw) at days 60, 90, 120 and 150 compared to baseline after intradermal injection of IncobotulinumtoxinA in the upper two thirds of the face by using Visioscan® VC 20plus Change in skin physiology parameters (pH, TEWL, Sebumetry, Cutometry, Corneome-try) at days 30, 60, 90, 120 and 160 within the treatment areas Response in skin quality at days 30, 60, 90, 120, 150 as assessed by a blinded rater using validated skin quality assessment scales Change of skin microbiome at day 30 and 60 compared to baseline. Response at patient satisfaction at days 30, 60, 90, 120 and 150 for the overall appear-ance of the upper two thirds of the face, as assessed independently from each other by the investigator and the subject according to the Global Impression of Change Scale, i.e. a score of much improved (+2) or very much improved (+3). Response at patient satisfaction by Facial Appearance Self-Perception Questionnaire (FASAQ) by assessing the statements and marking them according to the percentage (0% = "I do not agree" to 100% = "I fully agree"). The statements relate only to the face and external appearance compare to baseline. Assessment of wrinkle intensity at rest and at maximum contraction. These assessments will be performed using validated assessment scales (Merz Aesthetics Scales) (see Ap-pendix 3) for the treated areas Glabella (GFL), Forehead (HFL)and periorbital wrinkles (LPL).;Timepoint(s) of evaluation of this end point: See E.5.2 | — |
Countries
Germany
Outcome results
None listed