Aesthetic Performance of an Injective Treatment for the Inner Thighs, Knees and Arms

Study Overview
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Brief Summary
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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.

Official Title
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Aesthetic Performance and Tolerance Evaluation of an Injective Intradermal Treatment for the Inner Thighs, Knees and Arms

Conditions
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Skin Flaccidity Inner Thighs Knees Arms

Intervention / Treatment
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* Device: SUNEKOS ® Body


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Pregnancy; lactation; smokers; 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; cancer; 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUNEKOS ® Body<br>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). | Device: SUNEKOS ® Body<br>* SUNEKOS ® Body is a medical device (class III). The study product was injected at level of the inner thighs, knees and arms by needle (29 G) using the interstitial fluid technique (IFT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of inner arm skin laxity clinical grade | Skin laxity clinical grade, according to a visual score from 1 (no flaccidity) to 5 (very severe flaccidity) | baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks | 
| Change from baseline of inner arm skin roughness clinical grade | Skin roughness clinical grade, according to a visual score from 1 (no roughness) to 5 (very severe roughness) | baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks | 
| Change from baseline of inner thigh skin laxity clinical grade | Skin laxity clinical grade, according to a visual score from 1 (no flaccidity) to 5 (very severe flaccidity) | baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks | 
| Change from baseline of inner thigh skin roughness clinical grade | Skin laxity clinical grade, according to a clinical score from 1 (no roughness) to 5 (very severe roughness) | baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks | 
| Change from baseline of inner knee skin laxity clinical grade | Skin laxity clinical grade, according to a clinical score from 1 (no flaccidity) to 5 (very severe flaccidity) | baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks | 
| Change from baseline of inner knee skin roughness clinical grade | Skin laxity clinical grade, according to a visual score from 1 (no roughness) to 5 (very severe roughness) | baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks | 
| Change from baseline of superficial skin hydration | 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. | baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks | 
| Change from baseline of deep skin hydration | 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) | baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks | 
| Change from baseline of skin density | 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. | baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks | 
| Change from baseline of photographic documentation | 2D pictures of the inner arm, thigh and knee | baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks |