Status:
COMPLETED
Aesthetic Performance of an Injective Treatment for the Inner Thighs, Knees and Arms
Lead Sponsor:
Derming SRL
Conditions:
Skin Flaccidity Inner Thighs Knees Arms
Eligibility:
FEMALE
40-65 years
Phase:
NA
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
- 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
- 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.
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04113265
Start Date
May 20 2019
End Date
September 30 2019
Last Update
October 4 2019
Active Locations (1)
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1
DERMING
Milan, MI, Italy, 20159