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

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Flaccidity Inner Thighs Knees Arms
• Intervention / Treatment: Device: SUNEKOS ® Body

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20159
      • DERMING

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: SUNEKOS ® Body; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Derming SRL

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: E0719

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No