Safety and tolerability of STAR particles on chronic hand eczema, atopic dermatitis and vitiligo patients: a pilot study
Tolerability of topically applied STAR particles will be assessed in subjects with atopic dermatitis (AD), chronic hand eczema (CHE), or vitiligo
STAR particles are sub-millimeter medical devices made of biocompatible materials that, when rubbed on the skin, create transient micro-pores, allowing the delivery of topical drugs and potentially enabling the treatment of skin conditions. This study aims to assess the safety and tolerability of STAR particles in patients with atopic dermatitis (AD), chronic hand eczema (CHE), or vitiligo. The study products are the STAR particles gel formulation and vehicle (gel formulation without STAR particles), without any active ingredient. Each participant will have application areas of 3x3 cm in non-lesional and lesional skin to receive both study products (intraindividual design). In vitiligo subjects, each study product will be applied daily for eight consecutive days. In AD and CHE subjects, each study product will be applied on Days 1, 3, 5, and 8, for a total of four applications. Overall, application on Days 1, 2, and 8 will be performed at the study centre by trained personnel. Application on Day 3 will be performed by the subject at the study centre under the supervision of the trained personnel and application from Day 4 to Day 7 will be performed by the subject himself/herself at home when applicable. The study products will be applied by rubbing in a circular direction with the index and middle fingers using pressure. Approximately 90mg (10mg/cm2) of product will be applied in each area for 30 seconds. Five minutes after the end of the product application, the STAR particles will be removed with a dry tissue or dry gauze pad. A demonstration of the adequate pressure to be applied by the investigator and the subjects will be carried out using an appropriate scale. An Instruction For Use (IFU) will be provided to the investigator and the subjects. Subjects will be educated and guided on area delimitation and application methods by the study staff and the IFU.
Current key inclusion criteria as of 19/03/2026: 1. Subject with a clinically confirmed diagnosis of only one of the following conditions: chronic hand eczema (CHE), atopic dermatitis (AD) or non-segmental vitiligo 2. All subjects should have two (2) symmetrical areas of at least 3 x 3 cm without lesions (non-lesional skin) on the anterior forearm 3. For vitiligo: Subject has clinical diagnosis of stable non-segmental vitiligo, defined as no new depigmented lesions or progression of pre-existing depigmented lesions, and absence of Koebner phenomenon within approximately the last 12 months (information obtained from medical chart or subject’s physician, or directly from subject) 4. For vitiligo: subject has non-facial vitiligo that can accommodate two application areas on non-active lesional skin of 3 x 3 cm in easy-to-treat areas, including but not limited to the trunk, arms, or thighs. They should not be located on the palmar surface of the hands, plantar surface of the feet, elbows, scalp, genitals, or intertriginous areas. If on the trunk, the application areas should be ≥ 3 cm apart 5. For AD: subject has two application areas on lesional skin of 3 x 3 cm on symmetrical body areas and excluding face, scalp, genitals, axillae, groin, and feet. The difference in the Total Sign Score between both lesions should not exceed 1 6. For CHE: subject has four application areas of 3 x 3 cm (on the palm and dorsum of both hands) with symmetrical lesion, including: both palms and dorsum of both hands are affected; both palms are affected, and both dorsum are not affected; both dorsum are affected, and both palms are not affected 7. Female subjects of childbearing potential must use a reliable method of contraception and agree not to change it during the study 8. Subject able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements o
1. Female who is pregnant or breastfeeding or who plans to become pregnant during the study 2. Subject with known allergy to any materials and/or ingredients of the study products 3. Subject with known allergy to Gentian Violet stain 4. Known triggers for CHE (allergic or irritant) cannot be avoided during the course of the study 5. Subject with any other inflammatory skin disease or evidence of other skin conditions on the treatment areas 6. Subject with physical urticaria (including dermatographism) or angioedema 7. Subject with any clinically significant cutaneous or systemic infection including primary viral infections of the skin (e.g. herpes, HIV, hepatitis B) 8. Subject has used systemic treatments that could affect vitiligo, CHE, or AD within 8 weeks prior to the pretreatment period or within 5 half-lives, whichever is longer 9. Subject with an immunosuppressive disease 10. Subject who has any other clinically significant medical condition or physical/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with the interpretation of investigation results 11. Subject who has used topical skin care on the treatment areas within 24h prior to Day 1/Baseline 12. Subject who has used within one week prior to the study topical dermatological drug therapy on the treatment areas. Topical treatment of vitiligo, CHE, and AD will be allowed in non-application areas 13. Subject who has used systemic treatments such as analgesics (including paracetamol) within 24h prior to Day 1/Baseline or antihistamines within one week prior to Day 1/Baseline 14. Subject impossible to be contacted in case of emergency 15. Subject currently participating or having participated in another clinical trial/investigation during the month preceding inclusion 16. Subject who had been deprived of their freedom by administrative or legal decision or is under care of guardian or legal guardianship or subject hospitalized in a medical or so