DRKS00021121尚未招募未知
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 - ASIIT
Rosenpark Research GmbH0 个研究点目标入组 40 人开始时间: 2020年3月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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