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

Not Applicable

Completed

• Conditions: Skin Flaccidity Inner Thighs Knees Arms
• Interventions: Device: SUNEKOS ® Body

• Registration Number: NCT04113265
• Lead Sponsor: Derming SRL

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-20
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-02
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SUNEKOS ® Body	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).

Primary Outcome Measures

Name	Time	Method
Change from baseline of inner knee skin roughness clinical grade	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	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	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	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	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	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	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	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	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	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.

Trial Locations

Locations (1)

DERMING; 🇮🇹 Milano, MI, Italy