Tolerability of topically applied STAR particles will be assessed in subjects with atopic dermatitis (AD), chronic hand eczema (CHE), or vitiligo Skin and Connective Tissue Diseases
Conditions
Interventions
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 en
Sponsors
Aldena Therapeutics
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 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 of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on Investigator’s judgement 9. Subject affiliated to a health social security system (according to French Law) _____ Previous key inclusion criteria: 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 hands, wrists, 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 Sig
Exclusion criteria
Exclusion criteria: 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 social establishment for any reason 17. Subject having received 6000 euros indemnities for participation in clinical trials/investigations in the 12 previous months, including participation in the present study (according to French Law)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability will be assessed via the following outcome variables over 8 days followed by a 5-day follow-up period: 1. The incidence and severity of adverse events, serious adverse events, and application site reactions measured using Case Report Forms (CRF) 2. The incidence and severity of adverse device effects, serious adverse device effects measured using Case Report Forms (CRF) 3. Recording vital signs, including measurement of systolic and diastolic blood pressure and pulse rate in the sitting position, measured using standard methods 4. Performing physical examinations evaluating the skin (other than the study disease), lungs, abdomen, eyes/ears/nose/throat, neurological function, musculoskeletal system, lymph nodes, and cardiovascular system | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assess the skin puncture measured using Gentian Violet (GV) staining on Day 1 and Day 8 2. Monitor skin permeability measured using the Trans-Epidermal Water Loss (TEWL) test before and after product application on Day 1 and Day 8 3. Erythema and pigmentation changes measured using a clinical assessment on Day 1, Day 2 (for vitiligo patients only), Day 3, and Day 8 4. Acceptability of the product application measured using a patient questionnaire on Day 1 and Day 8 5. Usability feedback assessment measured using a usability questionnaire on Day 8 Exploratory outcome measures: 1. Depth of transepidermal poration or STAR skin embedment measured using Optical Coherence Tomography (OCT) imaging before and after product application 2. Skin colonization (Staphylococcus aureus and total aerobic bacterial count) measured using microbial counting and standard laboratory techniques on Day 1 and Day 8 skin swabs | — |
Countries
France
Contacts
Public ContactCarine Blanchard
Outcome results
None listed