L70.0
Conditions
Interventions
Group 1: Use of the Skinapy app by the patient in addition to the SOC (Standard of Care) for 12 weeks. Patients have access to all usual SOC services except for comparable digital interventions. The
Sponsors
DERMAFY Group GmbH
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects =12 and =65 years of age at the time of the Informed Consent signature 2. Signed informed consent form of the patient 3. Signed assent form of the patient´s legal guardian for adolescents <18 years 4. Diagnosis of acne with grade 2 to 4 on the 5-grade IGA scale (i.e., at least mild form of acne) at Screening Visit confirmed by an investigator (specialist physician) with the following ICD-10 Code: L70.0: Acne vulgaris 5. Decision of the investigator to start new acne treatment before study inclusion 6. Available, Android- or iOS-based and compatible mobile device with daily access to compatible Android- or iOS version for using the Skinapy app 7. Physical as well as psychological and cognitive abilities to use the smartphone 8. Internet access for the app application and questionnaire response 9. Email address for registration 10. Sufficient knowledge of spoken and written German language 11. Subjects who are willing to comply with the study requirements during the entire study duration and including allowance of face photography in specified visits. 12. Subject is willing and able to comply with study instructions, read, understand, and complete required questionnaires in German, and commit to attend all study visits 13. Subject is motivated to use the app regularly
Exclusion criteria
Exclusion criteria: 14. Missing signed informed consent form of the patient and/or his legal guardians (for adolescents <18 years) 15. Diagnosis of acne conglobate (L70.1) 16. Other acne diagnosis and types (e.g., syndromatic forms of acne, hidradenitis suppurativa, acne varioliformis, acne tropica or acné excoriée, acne mechanica, acne medicamentosa (Drug-induced acne), Chlor-acne, acne neonatorum (s. Pityrosporum Follkulitis des Säuglings), baby acne, tropical acne, poisonous acne reaction, Mallorca-acne, acne tarda, primary exogen trigger acne (e.g. oil, tar, radiation) 17. Severe acne without showing relevant improvements under systemic antibiotics or retinoid therapy 18. Subject with excessive facial hair, facial skin disorders, skin reactions that may interfere with the study assessments in the Investigator’s opinion (including, but not limited to: actinic keratosis, eczema, psoriasis, seborrheic dermatitis, rosacea, acute or recent sunburn) or skin infection 19. Known allergies or intolerances so that standard medical acne treatment cannot be applied 20. Initiation or change of hormonal contraceptive use within 12 weeks prior to Screening Visit or planned during the study 21. Laser therapy four weeks prior to study screening or planned laser therapy during the study 22. Professional cosmetic skin treatment, e.g. done by a cosmetician, four weeks prior to study screening or planned treatment during the study 23. Surgical interventions in the region affected by acne in the last three months prior to screening or planned surgical interventions during the study 24. Subject who is currently participating, or has participated, within 30 days prior to Screening Visit, in any investigational, non-registered medicinal product, biological or device trial 25. Current usage of the Skinapy app or of comparable digital applications for acne vulgaris or usage in the last three months prior to study screening 26. Pregnancy or planned pregnancy within the next three months 27. Started with acne-unspecific medication that affects the skin (i.e. the acne) within the last three month or planned use during the study 28. History of severe psychiatric illness with suicide attempt 29. Currently diagnosed severe psychiatric illness with considerable strain or limitations in everyday life due to mental illness or mental problems 30. Other known conditions, comorbidities or concomitant treatments that indicate that a participation in the study is not advisable according to the investigator´s assessment 31. Previous participation in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative reduction of the total number of inflammatory and non-inflammatory lesions by total lesion count (TLC) before and after 12 weeks usage of the skinapy app | — |
Secondary
| Measure | Time frame |
|---|---|
| - Reduction in the severity of acne (IGA) - improvement in the health-related quality of life (Skindex-29) - improvement of the psychological well-being (WHO-5) - improvement in patient autonomy (PAM13-D) The questionnaires Skindex-29, WHO-5 and PAM13-D will be answered by patients at time points T0, T1 and T2. The IGA will only be assessed at T0 and T2. | — |
Countries
Germany
Contacts
Public ContactAndreas Pinter
Dept. of Dermatology, Venereology and Allergology, Goethe-University Frankfurt am Main
Outcome results
None listed