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

NCT04113265 | Completed

• 1 other identifier: E0719
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Flaccidity Inner Thighs Knees Arms

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

SUNEKOS ® Body

EXPERIMENTAL

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

Interventions

SUNEKOS ® Body DEVICE

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)

SUNEKOS ® Body

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DERMING

Milan, MI, 20159, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 2, 2019
• Study Start: May 20, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Locations

IT (1)