MILD TO MODERATE PAPULOPUSTULAR ACNE (ACNE TARDA)
Conditions
Interventions
Trade Name: Skinoren® 15% Gel
Pharmaceutical Form: Gel
INN or Proposed INN: AZELAIC ACID
CAS Number: 123-99-9
Other descriptive name: AZELAIC ACID
Concentration unit: % (W/W) percent weight/weight
Con
Sponsors
Charité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and Skin Science
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 53 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Skin surface parameter: smoothness (SEsm), measured by Visioscan® VC98;Secondary Objective: -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) ;Primary end point(s): Change of all primary variables between Baseline and End of study (Visit 4). ;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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change of all secondary variables between Baseline and End of study (Visit 4). ;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). | — |
Countries
Germany
Contacts
Public ContactJohanna Meinhard
Charité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and Skin Science
Outcome results
None listed