Clinical trial NCT04113265: Aesthetic Performance of an Injective Treatment for the Inner Thighs, Knees and Arms
Official title: Aesthetic Performance and Tolerance Evaluation of an Injective Intradermal Treatment for the Inner Thighs, Knees and Arms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Flaccidity Inner Thighs Knees Arms
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 24
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline of inner arm skin laxity clinical grade
timeFrame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
measure: Change from baseline of inner arm skin roughness clinical grade
timeFrame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
measure: Change from baseline of inner thigh skin laxity clinical grade
timeFrame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
measure: Change from baseline of inner thigh skin roughness clinical grade
timeFrame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
measure: Change from baseline of inner knee skin laxity clinical grade
timeFrame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
measure: Change from baseline of inner knee skin roughness clinical grade
timeFrame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
measure: Change from baseline of superficial skin hydration
timeFrame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
measure: Change from baseline of deep skin hydration
timeFrame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
measure: Change from baseline of skin density
timeFrame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
measure: Change from baseline of photographic documentation
timeFrame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: DERMING
state: MI
Study officials:
References: