Clinical trial NCT04002856: Aesthetic Performance of "Profhilo®" Injective Intradermal Treatment for the Neck
Official title: Aesthetic Performance and Tolerance Evaluation of "Profhilo®" Injective Intradermal Treatment for the Skin Roughness and Laxity of the Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Manifestations
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 25
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 aesthetic performance of the Hyaluronic acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique ("BAP" techinique ) in woman aged 40-65 years with skin flaccidity and roughness of the neck.


Eligibility criteria: Inclusion Criteria:

* female sex,
* 40-65 years,
* 3-4 neck roughness/laxity grade according to a clinical reference scale;
* asking for neck laxity and roughness 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 neck;
* accepting to not expose their neck 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 T1 (1 month after the 1st injection treatment execution, before the 2nd aesthetic procedure);
* Body Mass Index (BMI) variation (± 1) during the study period;
* performing skin treatments for neck aesthetic correction (biomaterials implants, neck lifting, botox injections, laser, chemical peeling) in the 6 months prior to the study start;
* performing permanent filler in the past;
* change in the normal habits regarding food, physical activity, neck cosmetic and cleansing use 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 9 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 neck skin roughness and laxity clinical grade
timeFrame: Baseline (T0), 1 month (T1), 4 months (T2)
measure: Change from baseline of superficial skin hydration
timeFrame: Baseline (T0), 1 month (T1), 4 months (T2)
measure: Change from baseline of deep skin hydration
timeFrame: Baseline (T0), 1 month (T1), 4 months (T2)
measure: Change from baseline of skin density
timeFrame: Baseline (T0), 1 month (T1), 4 months (T2)
measure: Change from baseline of skin plastoelasticity
timeFrame: Baseline (T0), 1 month (T1), 4 months (T2)
measure: Change from baseline of photographic documentation
timeFrame: Baseline (T0), 1 month (T1), 4 months (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: DERMING
state: MI
Study officials:
References: