Irritant contact dermatitis is a prevalent inflammatory skin disorder caused by the deleterious effects of external irritants, resulting in disruption of the epidermal barrier, cutaneous inflammation, and activation of innate immune responses. Current therapeutic approaches primarily include topical corticosteroids, which are highly effective but limited in duration of use due to well-documented adverse effects, and emollients, which lack intrinsic anti-inflammatory activity. Consequently, there is a substantial unmet need for safer yet efficacious therapeutic alternatives with both anti-inflammatory and skin-regenerative properties. The primary objective of this project is the development and clinical evaluation of topical liposomal formulations containing 18β-glycyrrhetinic acid for the treatment and prevention of irritant contact dermatitis. By employing liposomal technology as a targeted and enhanced dermal delivery system, the project aims to improve the bioavailability and therapeutic efficacy of a compound with well-established effects on epidermal barrier repair and attenuation of cutaneous inflammation. In the initial phase of the project, stable liposomes encapsulating 18β-glycyrrhetinic acid will be developed, forming the basis for subsequent topical liposomal formulations. Thereafter, the safety and clinical efficacy of the developed formulations will be evaluated in randomized, placebo-controlled clinical trials. The therapeutic effects will be assessed using a standardized model of surfactant-induced irritant contact dermatitis. The innovative nature of the project lies in the application of pharmaceutical nanotechnology and advanced formulation strategies, combined with the implementation of rigorous clinical research methodology. The ultimate goal is to enhance treatment efficacy and safety, reduce reliance on topical corticosteroids, and improve the quality of life of patients suffering from chronic inflammatory dermatoses.
The long-term objective of the project is to develop novel therapeutic options for the management of irritant contact dermatitis. Demonstration of the safety and efficacy of the developed formulations may enable a reduction in corticosteroid use and facilitate the introduction of therapies suitable for long-term, continuous application, with both anti-inflammatory and immunomodulatory effects. The formulations developed within this project may undergo further optimization and development, with the potential to result in a commercial product suitable for clinical use, possibly in collaboration with the pharmaceutical industry. Given the anticipated safety profile and pharmacological activity, these formulations may significantly improve patient quality of life by reducing the frequency and severity of dermatitis symptoms and enhancing treatment adherence due to improved tolerability. Furthermore, liposomal delivery systems developed in this project may be applicable to other dermatological conditions, including atopic dermatitis.
2. To formulate stable topical preparations containing liposome-encapsulated active substances;
3. To evaluate the safety and clinical efficacy of the developed formulations in healthy volunteers using an experimentally induced irritant contact dermatitis model;
4. To disseminate research findings through presentations at national and international scientific conferences and through publication in peer-reviewed scientific journals, including the completion and defense of one doctoral dissertation;
5. To integrate the methodologies employed during the project into educational activities, including graduate education and the supervision of student theses.
The project is designed to achieve clearly defined and measurable results in line with the programme objectives. The expected project outcomes are:
1. Successful project management and secured ethical approval for the conduct of clinical studies
2. Completed analysis of relevant scientific literature and registration of clinical study protocols
3. Developed and characterised liposomes and topical formulations, with publicly available data
4. Conducted clinical studies on efficacy and safety, with publicly available data
5. Contribution to the improvement of teaching and education of young researchers and PhD candidates
6. Dissemination of results through scientific publications, conference presentations, science popularisation activities and scientific mobility
7. Collaboration with academic and industrial partners
These indicators directly contribute to the following programme objectives:
1.1. Increasing the participation of public higher education institutions and public research institutes in competitive project funding
1.3. Strengthening international scientific collaboration and research activities
1.4. Strengthening human resources for scientific research
2.1. Encouraging the implementation of applied research activities, including projects in collaboration with industry
3.1. Improvement of study programmes
4.6. Popularisation of science and the arts
Assoc. Prof. Tonći Batinić, PhD; Prof. Dolores Biočina Lukenda, PhD; Prof. Dolores Britvić, PhD; Prof. Marija Definis, PhD; Toni Durdov, MPharm; Prof. Damir Fabijanić, PhD; Assoc. Prof. Ivan Galić, PhD; Assist. Prof. Ivana Gunjača, PhD; Assoc. Prof. Danijela Kalibović Govorko, PhD; Prof. Vedran Kovačić, PhD; Assist. Prof. Mladen Lešin, PhD; Prof. Boris Lukšić, PhD; Assist. Prof. Bruno Lukšić, PhD; Ivanka Maleš, MPharm; Prof. Darko Modun, PhD; Assoc. Prof. Tomislav Omrčen, PhD; Prof. Marija Raguž, PhD; Assoc. Prof. Veljko Rogošić, PhD; Assoc. Prof. Ana Šešelja Perišin, PhD; Assist. Prof. Željko Šundov, PhD; Prof. Tade Tadić, PhD; Prof. Snježana Tomić, PhD; Prof. Eduard Vrdoljak, PhD; Assist. Prof. Jonatan Vuković, PhD; Prof. Marko Vulić, PhD; Prof. Tatjana Zemunik, PhD; Assoc. Prof. Ljubo Znaor, PhD.
