E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
MILD TO MODERATE PAPULOPUSTULAR ACNE (ACNE TARDA) |
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E.1.1.1 | Medical condition in easily understood language |
MILD TO MODERATE ACNE |
milde bis mittelschwere Akne |
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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 |
Skin surface parameter: smoothness (SEsm), measured by Visioscan® VC98 |
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E.2.2 | Secondary objectives of the trial |
-Skin surface parameters: roughness (SEr), scaling (SEsc), wrinkles (SEw) measured by Visioscan® VC98 -Skin elasticity parameters: elastic deformation (mm), viscoelastic deformation (mm), maximum extension (mm) , elastic resilience (mm) measured by Cutometer® MPA 580 -Intensity and spread of the pigmentation (in arbitrary units based on computerized image analysis by Canfield Scientific, Inc) -Course of intensity and spreading of the pigmentation (brightness- (L*), red- (a*) and yellow chrominance (b*) measured by broadband spectrophotometry) -Quality of life (Dermatology Life Quality Index (DLQI)) -Investigator's Static Global Assessment (ISGA) (0 to 5) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Female volunteers -Age 20 - 45 -Acne papulopustulosa of the face (acne tarda) -ISGA Score 2 (some non-inflammatory lesions, with few inflammatory lesions) or 3 (non-inflammatory lesions predominate, with multiple inflammatory lesions ) -Good general condition and good state of health -Written informed consent -Use of a highly effective method of birth control#, if use of a hormonal method, the same drug has to be used since at least 6 month -Nonsmokers or smokers of maximum 5 cigarettes/day -BMI between 20 and 28 kg/m²
#: Defined as a method that results in a low failure rate [i.e., less than 1% per year (Pearlindex ≤1)] when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomized partner.
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E.4 | Principal exclusion criteria |
-Severe form of Acne (ISGA score 4 or higher) -Other dermatological disorders: rosacea, atopic dermatitis, perioral dermatitis, psoriasis, -Previous smoothing or ablative procedures (cryotherapy, fruit acid -/TCA peelings, Fraxel Laser etc.) within the last 3 months -Participation in a clinical trial within the last 30 days prior Baseline -Planned absences during scheduled visits or planned or active pregnancy during the course of the study -Severe acute or chronic diseases Known allergy or hypersensitivity to the Investigational product orany of the formulation ingredients. -Current acne treatment with topical or systemic acne therapeutics or treatment as detailed below -Intake or use of the following medication: -Systemic Isotretinoin (within the last 6 month prior Baseline) -Systemic antibiotics (within the last 4 weeks prior Baseline) -Systemic corticosteroids (within the last 4 weeks prior Baseline) -Systemic non-steroidal anti-inflammatory drugs in dosage for the treatment of inflammations (within the last 4 weeks prior Baseline) -Topical retinoids (extensive application over the body or any use on the face within the last 2 weeks prior Baseline) -Topical corticosteroids (extensive application over the body or any use on the face within the last 2 weeks prior Baseline) -Topical use of non-steroidal anti-inflammatory drugs for the treatment of inflammations (extensive application over the body or any use on the face within the last 2 weeks prior Baseline) -Use of self-tanning agents in the face within the last 2 weeks prior Baseline -Topical acne treatments including over-the-counter preparations and medicated cleansers but excluding cosmetic (make-up) products (within the last 2 weeks prior Baseline) -Intensive UV-exposition or regular visits of solariums within the last 4 weeks prior Baseline or during the course of the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Change of all primary variables between Baseline and End of study (Visit 4).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of study and trend of the change in variables during study course (Visit 1, 2, 3, 4).
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E.5.2 | Secondary end point(s) |
Change of all secondary variables between Baseline and End of study (Visit 4).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of study and trend of the change in variables during study course (Visit 1, 2, 3, 4).
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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.8.3 |
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.8.5 | 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 | Yes |
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |