A randomized, evaluator-blind comparative study with a long-term extension to evaluate performance and safety of Belotero® Balance and no-treatment control for the treatment of facial acne scars
- Conditions
- Scar conditions and fibrosis of skinfacial acne scarsL90.5
- Registration Number
- DRKS00021121
- Lead Sponsor
- Rosenpark Research GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objectives:<br>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.<br>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 Outcome Measures
Name Time Method