Pregled sestave in varnosti kozmetičnih izdelkov ter medicinskih pripomočkov za nego brazgotin

Vidic, Klara (author), Sollner Dolenc, Marija (mentor)

Namen izdelkov za nego brazgotin je ublažiti njihov videz, izboljšati njihovo elastičnost in zaščititi poškodovano območje pred zunanjimi vplivi. Uporabljajo se pri posameznikih, ki imajo že popolnoma zaceljeno rano, bodisi od raznih poškodb, operacij, dermatoloških posegov ali opeklin. V uvodu smo povzeli ključne faze celjenja ran, ki so pomembne pri nadaljnjem brazgotinjenju, celične procese v brazgotini, vplivu UV svetlobe na njihov videz in možne zaplete, kot sta nastanek hipertrofičnih in keloidnih brazgotin. Sledile so regulativne razlike med dvema vrstama preučevanih izdelkov, med kozmetičnimi izdelki, reguliranimi z Uredbo ES 1223/2009, ki zahteva poročilo o varnosti, in medicinskimi pripomočki, ki sledijo Uredbi (EU) 2017/745 ter zahtevajo klinično oceno in dokazano učinkovitost. Namen diplomske naloge je bil pregledati tako sestavo kot tudi varnost kozmetičnih izdelkov in medicinskih pripomočkov ter jih med seboj primerjati. V analizo smo vključili 53 izdelkov, ki so dostopni na slovenskem trgu, od tega 35 kozmetičnih izdelkov in 18 medicinskih pripomočkov. Poseben poudarek smo namenili skupinam sestavin, ki so splošno povezane s tveganjem za nastanek preobčutljivosti, draženja kože in drugimi neželenimi učinki. Med njih spadajo konzervansi, dišave, barvila in površinsko aktivne snovi. Kot najpogostejši konzervans se je pojavil fenoksietanol, med alergenimi dišavami linalol in limonen, med površinsko aktivnimi snovmi pa cetearil alkohol. Med barvili smo našli le dve, in sicer CI 26100 (rdeča) in CI 77891 (bela). Preverili smo še ostale pomembne sestavine, kot so aktivne sestavine, okluzivi, emolienti in silikoni, ki so njihova posebna podskupina in so široko uporabljeni v namen nege brazgotin. Ugotovili smo, da so medicinski pripomočki po sestavi enostavnejši in zagotavljajo večjo varnost, kar je razvidno tako iz njihove regulative kot iz samega pregleda sestave. Pri toksikološki oceni sestavin smo ugotovili, da so vse sestavine v primeru upoštevanja priporočenih koncentracij varne za uporabo. Pomembno je upoštevati tudi to, da je pomen varnosti izdelkov za nego brazgotin še toliko večji, ker je pri poškodovani koži barierna funkcija epidermisa oslabljena, kar pa omogoča večjo možnost perkutane absorpcije snovi in posledično večje tveganje za lokalne ali sistemske učinke. Razlike med izdelki se kažejo tudi v ceni, pri čemer so medicinski pripomočki povprečno dražji, kar lahko pripišemo zahtevnejšim regulativnim in kliničnim zahtevam.

• Language: Slovenian
• Keywords: brazgotine, celjenje ran, zunajcelično ogrodje, toksikološki profil, varnost
• Work type: Bachelor thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2025
• PID: 20.500.12556/RUL-172155
• Publication date in RUL: 06.09.2025

Secondary language

• Language: English
• Title: Review of the composition and safety of cosmetic products and medical devices for scar care

Abstract

The purpose of scar care products is to alleviate scar appearance, improve skin elasticity, and protect damaged areas from external factors. They are intended for individuals with fully healed wounds resulting from injuries, surgeries, dermatological procedures, or burns. The introduction outlines key wound healing stages relevant to scar formation, cellular processes in scars, the impact of UV radiation on scar visibility, and potential complications such as hypertrophic and keloid scarring. Regulatory distinctions between two product categories were examined: cosmetic products governed by Regulation (EC) No 1223/2009 (requiring safety reports) and medical devices complying with Regulation (EU) 2017/745 (mandating clinical evaluation and proven efficacy). This thesis aimed to analyze and compare the composition and safety of cosmetic products and medical devices. We evaluated 53 market-available products in Slovenia (35 cosmetics, 18 medical devices), with emphasis on ingredients associated with sensitization, skin irritation, and adverse effects. These include preservatives, fragrances, colorants, and surfactants. The most common preservative was phenoxyethanol; among allergenic fragrances, linalool and limonene; and among surfactants, cetearyl alcohol. We were positively surprised by colorants, finding only two, CI 26100 (red) and CI 77891 (white). We also examined other key ingredients like actives, occlusives, emollients, and their subgroup silicones, widely used in scar care. We determined that medical devices have simpler formulations and offer greater safety, evident both from their regulatory framework and compositional review. Toxicological assessment of ingredients confirmed that all are safe when used at recommended concentrations. However, safety is paramount for scar care products because the barrier function of the epidermis is compromised in injured skin, enabling greater percutaneous absorption of substances and consequently higher risks of local and systemic effects. Differences are also seen in price: medical devices are generally more expensive, likely due to stricter regulatory and clinical requirements.

• Keywords: scars, wound healing, extracellular matrix, toxicological profile, safety