ISRCTN18051758进行中（未招募）未知
Evaluation of the efficacy and safety of the acne scar treatment pen in the treatment of ice pick acne scars on the face
Medical Brands B.V.0 个研究点目标入组 66 人开始时间: 2021年7月13日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy subject
- •2. Male or female
- •3. Written informed consent must be obtained from the subject
- •4. Age between 18 and 60 years
- •5. Phototype: Fitzpatrick skin types I, II, III, IV
- •6. Subjects with at least five icepick acne scars per hemiface, and with no more than 30% difference between the two sides of the face, as determined by clinical examination and with comparable pathology on each hemiface as judged by the Investigator
- •7. Subject having stopped any topical anti-acne treatment since at least 6 months before inclusion
- •8. Willing to refrain from receiving cosmetic face treatments for the duration of the study
- •9. Willing to use sunscreen for the duration of the study
- •10. Female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end
排除标准
- •1. Subject considered by the Investigator likely to be non-compliant with the protocol
- •2. Patient enrolled in another clinical trial during the test period
- •3. Woman being pregnant, nursing or planning a pregnancy during the course of this study
- •4. Subject having a known allergy to one of the constituents of the tested products
- •5. Patient suffering from serious or progressive diseases (to investigator's discretion), including but not limited to diabetes, peripheral circulatory disease, HIV, immunosuppressive pathology
- •6. Subject with cutaneous pathology on studied zone, including but not limited to acne, rosacea, angioma, dermatitis, herpes labialis
- •7. People who were treated with tretinoin within 6 months prior to treatment in this study
- •8. History of skin tightening or injectable filler of any type within the last year
- •9. History of facial laser treatment, including ablative and non-ablative resurfacing laser treatments and rejuvenation laser treatments in the last 6 months
- •10. History of cosmetic treatments with neurotoxins within the last 3 months
- •11. History of chemical peel or dermabrasion of face and neck within the last 4 weeks
- •12. History of keloid formation
- •13. History of hyperpigmentation
- •14. Fitzpatrick skin types V and VI
- •15. Prior poor reaction to a chemical peel
- •16. Subject who was abroad in a country with a higher incidence rate of Covid-19 than Poland, within 14 days before the beginning of the study.
- •17. Subject presenting following symptoms: cough, shortness of breath, elevated body temperature – equal and above 37.5°C
- •18. Subject who have had contact with any person infected with COVID-19 within 10 days before the beginning of the study
- •19. Subject who are currently home quarantined, as recommended by the Sanitary Inspection
研究者
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