facial acne scars L90.5
Conditions
Interventions
Group 1: The aim of this study is to evaluate the effectiveness and safety of Belotero® Balance for the treatment of acne scars on the face.
After randomization, either the left or right half of the f
Sponsors
Rosenpark Research GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Presence of facial acne scars within the treatment area on each cheek. 2. Symmetric scar severity on both cheeks as assessed by the Blinded Evaluator. 3. Intent to undergo treatment of facial acne scars. 4. Men or women aged 18 to 55 years, inclusive. 5. Ability to adequately understand and accept the obligation to follow study instruction. 6. Signed and dated informed consent to participate in the study 7. Ability to read and complete questionnaires provided in local language. 8. Cooperative and willing to comply with the instructions and procedures.
Exclusion criteria
Exclusion criteria: 1. Acute acne with inflammatory component within 6 months before baseline. 2. Start or dose change of isotretinoin within 6 months before baseline. 3. Pregnant, breast-feeding women, women who intent to get pregnant within the next 24 months, or women who are of childbearing potential and not practicing a reliable method of birth control. 4. Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics. 5. History of bleeding disorders in the opinion of the Treating Investigator 6. Any medical condition or concomitant medication that, in the opinion of the Treating Investigator, has the potential to interfere with the investigation or increase the risk of adverse events. 7. Any history of aesthetic treatments that, in the opinion of the Treating Investigator, has the potential to interfere with the investigation or increase the risk of adverse events. 8. Active skin disease, inflammation or related conditions, such as but not limited to infections, perioral dermatitis, seborrheic eczema, rosacea, psoriasis, or herpes zoster or herpes simplex in the face. 9. Presence of facial hair that may interfere with performance evaluations. 10. Severe pre-aged skin. 11. Any other condition preventing the subject from entering the study in the Investigator’s opinion, e.g. subjects not likely to avoid other facial aesthetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result. 12. Study site personnel, close relatives of the study site personnel, or close relatives of employees at the Sponsor company. 13. Subject who is imprisoned or is lawfully kept in an institution. 14. Patients currently participating in any other clinical trial or within 28 days before treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives: The primary objective of the study is to show greater aesthetic improvement in facial acne scars treated with Belotero® Balance compared with untreated facial acne scars in the same subject using a split-face design. The primary endpoint is the proportion of subjects for whom the treated side has a higher grade of aesthetic improvement (GAIS) compared to the untreated side at live assessment by a Blinded Evaluator 6 months after baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: • Aesthetic improvement of facial acne scars using the Global Aesthetic Improvement Scale (GAIS) by the subject and Treating Investigator at month 3, 6, 12, 18 and 24 compared to baseline. • Aesthetic improvement of facial acne scars using the Global Aesthetic Improvement Scale (GAIS) by the Blinded Evaluator at month 3 and 6 compared to baseline. • Overall severity of facial acne scars using the Investigator’s Scar Global Assessment (SGA) by Blinded Evaluator at baseline, month 3 and 6. • Overall severity of facial acne scars using the Self-assessment of Clinical Acne-Related Scars (SCARS) by subject at baseline and month 3, 6, 12, 18 and 24. • Impact on quality of life using the facial acne scar quality of life (FASQoL) by subject at baseline and month 3, 6, 12, 18 and 24. • Skin topography measurement using structured-light 3D scanner (PRIMOSLargeField, Canfield Scientific) at baseline and month 3, 6, 12, 18 and 24. • Skin mechanical properties of selected scars using cutometry at baseline and month 3, 6, 12, 18 and 24. • Subjects satisfaction with treatment result using subject questionnaires at month 3, 6, 12, 18 and 24. • Local tolerability by the assessment of post-treatment events after each treatment. • Short- and long-term safety throughout the entire study by collecting AEs and device deficiencies. | — |
Countries
Germany
Contacts
Public ContactNils Krüger
Rosenpark Research GmbH
Outcome results
None listed