Aesthetic Performance and Tolerance Evaluation of an Injective Intradermal Treatment for the Inner Thighs, Knees and Arms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Derming SRL
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from baseline of inner knee skin roughness clinical grade
研究概览
简要总结
The objective of this study is to investigate the efficacy of the "SUNEKOS® Body" in woman aged 40-65 years with skin flaccidity of the inner thighs, knees and arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female sex;
- •age 40-65 years;
- •asking for inner thighs, knees and arms laxity restoration;
- •available and able to return to the study site for the post-procedural follow-up examinations;
- •accepting to not change their habits regarding food, physical activity, cosmetic and cleansing products for the body;
- •accepting not to expose their body to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study, without appropriate sun protection;
- •accepting to sign the informed consent form.
排除标准
- •Pregnancy;
- •lactation;
- •alcohol abuse and/or drug use;
- •subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
- •subjects not in menopause who do not accept to perform the pregnancy test at T0 (before the 1st aesthetic procedure) and at T4i (before the last injection treatment execution);
- •Body Mass Index (BMI) variation (± 1) during the study period;
- •performing skin treatments for knee, thighs and arms aesthetic correction (carboxytherapy injections, body lifting, laser, infrared light, bipolar radiofrequency, vacuum and mechanical massage) in the 6 months prior to the study start;
- •aesthetic surgical procedure on knee, thighs and arms in the past;
- •change in the normal habits regarding food, physical activity, cosmetic products and cleansing for the body during the month preceding the test;
- •sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
- •subjects whose insufficient adhesion to the study protocol is foreseeable;
- •participation in a similar study currently or during the previous 6 months
- •Dermatitis;
- •presence of cutaneous disease on the tested area, as lesions, scars, malformations;
- •recurrent facial/labial herpes;
- •clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne).
- •Diabetes;
- •endocrine disease;
- •hepatic disorder;
- •renal disorder;
- •cardiac disorder;
- •pulmonary disease;
- •neurological or psychological disease;
- •inflammatory/immunosuppressive disease;
- •drug allergy.
- •Anticoagulants and antiplatelet drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);
- •using of drugs able to influence the test results in the investigator opinion.
研究组 & 干预措施
SUNEKOS ® Body
The 1st treatment was performed during T0 visit, after the basal evaluations planned by the study procedure and repeated 3 more times with an interval of 1 week (T2i, T3i and T4i).
干预措施: SUNEKOS ® Body (Device)
结局指标
主要结局
Change from baseline of inner knee skin roughness clinical grade
时间窗: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin laxity clinical grade, according to a visual score from 1 (no roughness) to 5 (very severe roughness)
Change from baseline of superficial skin hydration
时间窗: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin electrical capacitance value was measured mono-laterally on the right or left inner arm, thigh and knee with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.
Change from baseline of photographic documentation
时间窗: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
2D pictures of the inner arm, thigh and knee
Change from baseline of inner arm skin laxity clinical grade
时间窗: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin laxity clinical grade, according to a visual score from 1 (no flaccidity) to 5 (very severe flaccidity)
Change from baseline of inner knee skin laxity clinical grade
时间窗: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin laxity clinical grade, according to a clinical score from 1 (no flaccidity) to 5 (very severe flaccidity)
Change from baseline of inner arm skin roughness clinical grade
时间窗: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin roughness clinical grade, according to a visual score from 1 (no roughness) to 5 (very severe roughness)
Change from baseline of inner thigh skin laxity clinical grade
时间窗: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin laxity clinical grade, according to a visual score from 1 (no flaccidity) to 5 (very severe flaccidity)
Change from baseline of inner thigh skin roughness clinical grade
时间窗: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin laxity clinical grade, according to a clinical score from 1 (no roughness) to 5 (very severe roughness)
Change from baseline of deep skin hydration
时间窗: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the right or left inner arm, thigh and knee with MoistureMeterD (Delfin Technologies, Kuopio - Finland)
Change from baseline of skin density
时间窗: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
A little skin area of about 7 cm2 (at level of inner arm was pinched, in standardized conditions, using a specific device. Because of this "pinch" the skin profile changes depending on cutaneous density; when the skin is slack the "pinch" forms a lot of wrinkles. A picture of the skin pinched was taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to measure skin principal profilometric parameters.
次要结局
未报告次要终点
研究者
Adele Sparavigna
Principal Investigator
Derming SRL