DRKS00021121
Not yet recruiting
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 sites40 target enrollmentStarted: March 18, 2020Last updated:
Overview
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Rosenpark Research GmbH
- Enrollment
- 40
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- All
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
- •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.
Investigators
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