E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Skin perception after intradermal application of INCOBOTULINUMTOXIN A within upper and midface |
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E.1.1.1 | Medical condition in easily understood language |
Change in skin surface roughness before and 4 weeks after intradermal injection of IncobotulinumtoxinA (primary efficacy criterion). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
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) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |