Aesthetic Performance of an Injective Treatment for the I... | NCT04113265

NCT04113265

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

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)

Eligibility Module

Eligibility Criteria

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.