Aesthetic skin changes of the abdominal area, including reduced skin quality, decreased skin firmness, reduced skin elasticity, and the presence of abdominal folds.
Conditions
Interventions
Group 1: Intra-individual treatment of the lower abdomen with four treatment areas randomly assigned to the following interventions: RADIESSE® (1:1 dilution), RADIESSE® (1:2 dilution), a hybrid approa
comparisons are performed intra-individually between treatment areas.
Sponsors
Universität Hamburg Fakultät für Mathematik, Informatik und Naturwissenschaften (MIN) Institut für Biochemie und Molekularbiologie Fachbereich Kosmetikwissenschaft
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained from the participant prior to any study-related procedures. 2. Understanding of the study procedures and willingness to comply with all study requirements and assessments. 3. Desire to undergo a dermal treatment for the improvement of abdominal folds and skin quality in the abdominal area. 4. Willingness and ability to provide written consent for study-related photography and to comply with the standardized imaging procedures (e.g., removal of jewelry and cleansing of the treatment area). 5. Willingness to refrain from any additional aesthetic or medical treatments in the abdominal area during study participation (e.g., treatments outside the study, botulinum toxin treatments, ablative or fractional laser procedures, microdermabrasion, microneedling, chemical peels, non-invasive skin-tightening procedures, and surgical interventions). 6. Women of childbearing potential must agree to use a highly effective method of contraception throughout study participation. 7. Stable health status without uncontrolled systemic disease. 8. Fitzpatrick skin type I–VI. 9. Body mass index (BMI) between 19 and 25 kg/m². 10. Healthy skin within the treatment area.
Exclusion criteria
Exclusion criteria: 1. Previous treatment of the abdomen with autologous fat transfer, poly-L-lactic acid, or permanent dermal fillers (e.g., silicone or polymethylmethacrylate). 2. Previous treatment of the abdomen with collagen fillers, calcium hydroxylapatite fillers, and/or long-lasting hyaluronic acid fillers within 24 months prior to baseline. 3. Previous treatment of the abdomen with other hyaluronic acid fillers within 12 months prior to baseline. 4. Previous treatment of the abdomen with botulinum toxin, ablative or fractional laser procedures, microdermabrasion, microneedling, chemical peels, or non-invasive skin-tightening procedures within 6 months prior to baseline. 5. Non-stable use of anti-aging or skin-improving products in the abdominal area within 3 months prior to baseline. 6. Use of immunosuppressive or immunomodulatory medication, systemic corticosteroids, or skin-irritating topical products in the abdominal area within 2 months prior to study start. 7. Previous surgery, plastic surgery, or permanent implants in the abdominal area that could interfere with study outcomes. 8. Use of anticoagulant medication or supplements known to affect coagulation, unless discontinuation is possible according to the study protocol. 9. Acute or chronic infections, inflammatory conditions, or skin diseases in the treatment area. 10. Scars, tattoos, piercings, open wounds, sun damage, or other skin conditions that may interfere with study assessments. 11. Systemic autoimmune disease, sarcoidosis, or subacute bacterial endocarditis. 12. Excessive dermatochalasis, deep dermal scarring, or markedly sebaceous skin in the treatment area. 13. Severe allergies or a history of anaphylaxis. 14. Chronic alcohol or substance abuse. 15. Tendency to develop hypertrophic scars or keloids. 16. Systemic diseases associated with impaired wound healing. 17. Presence of an uncontrolled malignancy. 18. Known bleeding disorders. 19. Excessive hair growth in the treatment area that may interfere with standardized assessments. 20. Planned surgery or hospitalization during the study period. 21. Inability or unwillingness to comply with post-treatment instructions. 22. In the investigator’s opinion, lack of compliance, reliability, or cooperation. 23. Current smoking or smoking within 3 months prior to baseline. 24. Active tanorexia (tanning addiction). 25. Unwillingness to use consistent sun protection on the abdominal area throughout the study. 26. Medical conditions likely to require radiologic imaging of the abdomen during the study period. 27. Pregnancy or breastfeeding. 28. Known hypersensitivity to any investigational product or its components. 29. Prisoners or individuals under legal detention. 30. Participation in another clinical study within 30 days prior to baseline. 31. Previous randomization in this study. 32. Active skin lesions, infections, or irritations in the treatment area. 33. Male sex.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in abdominal fold appearance and skin quality 6 months after treatment compared with baseline, assessed using standardized photographs, the Scientific Assessment Scale of Skin Quality (SASSQ), and objective biophysical measurements (Cutometer®, Corneometer®, Colorimeter®, Visioscan®, and Ultrascan®). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Long-term efficacy Change in abdominal fold appearance and abdominal skin quality 12 months after treatment compared with baseline, assessed using standardized photographs, the Scientific Assessment Scale of Skin Quality (SASSQ), and objective biophysical measurements (Cutometer®, Corneometer®, Colorimeter®, Visioscan®, and Ultrascan®). 2. Participant satisfaction Participant satisfaction with the treatment outcome in the abdominal area at 6 and 12 months, assessed using a study-specific satisfaction questionnaire. 3. Investigator satisfaction Investigator satisfaction with the treatment outcome in the abdominal area at 6 and 12 months, assessed using a study-specific evaluation form. 4. Global aesthetic improvement Global aesthetic improvement of the abdominal area at 6 and 12 months, assessed using: Subject’s Global Aesthetic Improvement Scale for Wrinkles (sGAIS-Wrinkles) Investigator’s Global Aesthetic Improvement Scale for Wrinkles (iGAIS-Wrinkles) Subject’s Global Aesthetic Improvement Scale for Skin Quality (sGAIS-Skin Quality) Investigator’s Global Aesthetic Improvement Scale for Skin Quality (iGAIS-Skin Quality) 5. Safety Incidence, type, severity, and frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) throughout the 12-month study period. | — |
Countries
Germany
Contacts
Public ContactMaxine Bennek
Universität Hamburg Fakultät für Mathematik, Informatik und Naturwissenschaften Institut für Biochemie und Molekularbiologie Fachbereich Kosmetikwissenschaft
Outcome results
None listed