DRKS00032634招募中不适用
Open, monocentric, non-randomised clinical trial for the evaluation of the usability, applicability, efficacy and tolerability of the medical device Juläine® for the augmentation of the nasolabial fold.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Signed informed consent form
- •- Study participants who are 18 years of age or older and are able to give their consent.
- •- Study participants who wish to undergo volume augmentation therapy in the nasolabial fold area.
- •- Understanding of the study procedures and consent to participate in the study procedures.
- •- Volume deficiency of the nasolabial fold of moderate to very severe intensity (grades 2-4) on the Merz nasolabial folds scale. Established on the day of the baseline visit and prior to the start of the study up to a maximum of 6 months earlier.
- •- Symmetrical assessment of both nasolabial folds by the investigator (equal intensity of both nasolabial folds on the Merz nasolabial folds scale and no obvious asymmetries).
- •- The study participant is willing to refrain from interfering facial treatments during the study period, such as filler injections, botulinum toxin treatments, facial ablative or fractional laser treatments, microdermabrasion, chemical peels, plastic aesthetic surgical interventions, and observes contraindications, precautions and warnings.
排除标准
- •- Previous treatment in the past using calcium hydroxyapatite, silicone, polymethyl methacrylate (PMMA), fat injections, poly-L lactic acid in the area of the nasolabial fold.
- •- Plastic-aesthetic facial surgery in the past, which in the opinion of the investigator has a effect on the appearance of the nasolabial fold
- •- Treatment with hyaluronic acid containing fillers in the area of the nasolabial fold in the last 12 months as well as planned treatments within the study period
- •- Treatment within the last 6 months (as well as planned treatments within the study period) with facial dermal therapies (e.g., epilation, ultraviolet irradiation, radiofrequency ablation or non-ablative facial treatment, laser treatment, microdermabrasion, mechanical or chemical peels, non-invasive skin tightening (e.g., Ultherapy, Thermage), or surgical procedures)
- •- Treatment with botulinum toxin within the last 4 months (as well as planned botulinum toxin therapy within the study period).
- •- Systemic relevant immunosuppressive treatment (e.g. prednisolone, azahioprine, mycophenolate mofetil, rituximab) within the last 12 months (as well as planned therapy within the study period)
- •- Cosmetic/topical treatment with fruit/glycolic acid containing topicals in the area of the treated area within the last 30 days as well as 30 days after injection
- •- Known blood coagulation disorder or use of anticoagulants within the last 10 days before and planned use until 3 days after treatment (e.g., ASS, phenprocoumon, etc.)
- •- Known and/or documented allergy to any of the ingredients of Juläine®.
- •- Acute inflammation or infection in the treatment area or acute or chronic skin disease that, in the opinion of the investigator, may lead to an increased risk
- •- Facial nerve paresis
- •- Known history of hypertrophic scarring or keloid formation
- •- Current malignant disease (<5 years since initial diagnosis, except for basal cell carcinoma and squamous cell carcinoma of the skin outside of the treatment area)
- •- Parallel participation in another clinical trial up to 30 days prior to inclusion and up to 30 days after completion of the present study
- •- Pregnancy, lactation
- •- Known severe autoimmune diseases (e.g., scleroderma, lupus erythematosus, rheumatoid arthritis)
研究者
相似试验
尚未招募
2 期
Clinical Evaluation of Siddha Medicine Soosika Chooranam for Soothaga Vaayu (PCOD)CTRI/2024/06/069265Government Siddha Medical College, Chennai
尚未招募
2 期
Sangkaara vairavan for Bronchial asthmaCTRI/2024/05/068028Dr R Sasirekha
尚未招募
2 期
A study on Vengara chunnam for urolithiasis patientsCTRI/2024/06/069490Saranya
尚未招募
2 期
Athimathura Chooranam for High Blood PressureCTRI/2024/05/067698RAKSHANA
尚未招募
2 期
Brahmi Nei for Diabetic NeuropathyCTRI/2024/05/068124SHALINI S