L70.0
Conditions
Interventions
Group 1: Investigational Product (IP) composition: Water, Glycerin, Coco-Caprylate/Caprate, Cyclopentasiloxane, Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Zinc Gluconate, Glycolic Acid, Cit
Sponsors
NAOS, SAS
Eligibility
Sex/Gender
All
Age
12 Years to 25 Years
Inclusion criteria
Inclusion criteria: Subjects of both sexes and of any ethnic background between the ages of 12 and 25. Subjects with mild acne (facial involvement), with a number of inflammatory lesions (papules and or pustules) between 3 and 20 and with a number of non-inflammatory lesions (open and closed comedones) between 10 and 50, excluding the nasal pyramid. General assessment of acne severity (Investigator Global Assessment – IGA) mild (2). Signed informed consent from the study participants. For minors (under 18 years) the consent of the legal representative (i.e., parents) is required and the appropriate form has to be signed. No application of topical antimicrobial products (shampoo, soap, acne agent) or oral or over-the-counter acne products. Good health of the study participants without clinically significant study-related diseases, in the opinion of the investigator, which could affect the study data.
Exclusion criteria
Exclusion criteria: Use or discontinuation of regular use of over-the-counter (OTC) oral drugs in less than 2 weeks prior to the (first) administration of the IP. Use or discontinuation of occasional use of OTC drugs (except paracetamol, maximum 1 g/day) in less than 2 weeks prior to the (first) administration of the IP. Use on the face or discontinuation of any prescribed topical anti-acne drug, such as 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations but excluding cosmetic (make-up) products, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics in less than 2 weeks prior to the (first) administration of the IP. Use or discontinuation of the use of any prescribed systemic anti-acne drugs in less than 4 weeks [1) isotretinoin; 2) therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed Stage 2 only); 3) hormonal antiandrogens: cryproterone acetate or hormonal contraceptives including cyproterone acetate, chlormadinone acetate, drospirenone or dienogest; 4) spironolactone; 5) systemic steroids; 6) antibiotics, 7) other systemic treatment of acne vulgaris prior to the (first) administration of the IP with the exception of hormonal contraceptive (except hormonal contraceptives including cyproterone acetate, chlormadinone acetate, drospirenone or dienogest). Subject with an IGA score of clear (=0), almost clear (=1), moderate (=3), severe (=4) or very severe (=5). Subject with a clinical diagnosis of acne conglobata, excoriated acne, acne fulminans, secondary acne (chloracne, drug-induced acne), facial keloids, and hypertrophic scars, or another dermatological condition, or underlying disease that requires the use of interfering topical or systemic therapy. Subject exposed or planning excessive sun exposure within the study timeframe. Subject with any or dermatologic disorder that could be considered a differential diagnosis of acne, e.g. rosacea, keratosis pilaris, etc. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Use on the face within 4 weeks prior to Baseline of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) Acne surgery or 5) x-ray therapy or within 2 weeks 6) intralesional corticosteroids. Use for less than 3 months prior to Baseline of estrogens or oral contraceptives (except hormonal antiandrogens: cryproterone acetate or hormonal contraceptives including cyproterone acetate, chlormadinone acetate, drospirenone or dienogest); use of such therapy must remain constant throughout the study. Known hypersensitivity to the IP or any of their formulation ingredients Nursing mother or pregnant woman, as verified by a positive pregnancy test, or plan to become pregnant within the study timeframe. Subject that has used pigmenting agents (self-tanning agents) within the last two weeks prior to Baseline. Subject with abnormal findings, noted on a physical exam or laboratory result, that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of the study results. Subject with severe physical, neurological or mental disease that would interfere with the conduct and/or compliance of this clinical study as judged by the investigator. Subject with a history of, or known to, abuse alcohol or drugs. Evidence or suspicion that the subject m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total number of acne lesions at D84 compared with baseline. Change in the number of inflammatory / non-inflammatory acne lesions at D84 compared with baseline. Categorized (dichotomous) evaluation of the improvement of one degree of IGA severity score (improvement vs. no improvement) at D84 compared with baseline. Change in the total number of acne lesions / number of inflammatory acne lesions / number of non-inflammatory acne lesions at D84 compared with baseline, assessed by photography and a computerized evaluation system (Visia ® Canfield Inc., NJ, USA). Change of the amount of facial casual lipids and secreted sebaceous lipids at D84 compared with baseline using a lipid detection unit (Sebumeter ® , Courage & Khazaka, Duesseldorf, Germany). | — |
Secondary
| Measure | Time frame |
|---|---|
| Categorized (dichotomous) evaluation of the improvement by one degree of IGA severity score at D14, D28, D56 and D112 compared with baseline. Change in the total number of acne lesions / number of inflammatory acne lesions / number of non-inflammatory acne lesions at D14, D28, D56 and D112 compared with baseline. Change in the total number of acne lesions / number of inflammatory acne lesions / number of non-inflammatory acne lesions at D14, D28, D56 and D112 compared with baseline assessed by photography and a computerized evaluation system (Visia ® Canfield Inc., NJ, USA). Change of the amount of facial casual lipids and secreted sebaceous lipids at D28 and D56 compared with baseline using a lipid detection unit (Sebumeter ® , Courage & Khazaka, Duesseldorf, Germany). Change of the intensity of seborrhea (marked from 0 to 3: 0=nil, 1=light, 2=average, 3=high) at D14, D28, D56, D84 and D112 compared with baseline. Overall efficacy evaluation by the investigator and by the subjects using a 6-point scale (disappearance of lesions, significant improvement, average improvement, slight improvement, condition unchanged, condition worsened). Cosmetic perception of oily, shiny, sticky or comfort of the skin in all visits. Acne related quality of life using the self-reported CADI instrument (Cardiff Acne Disability Index)on D14, D28, D56 and D84. | — |
Countries
Germany
Contacts
Public ContactMichéle Sayag
NAOS, SAS
Outcome results
None listed