Skin changes due to chronic exposure to nonionizing radiation, unspecified
Conditions
Interventions
2 mL of Profhilo® will be injected into the middle-deep dermis by needle (29 G) using a bolus technique called “BAP” (Bio Aesthetic Point technique)
this technique involves a series of 10 micro-wheals on 3 vertical-lines (3-4-3 see Fig.1). The amount of product to be injected will be of 0.2 ml for each injection point. The 10 points BAP Neck Techn
Sponsors
For Trials Pesquisa Clínica Ltda
IBSA Farmaceutici Italia S.r.l.
Eligibility
Sex/Gender
Female
Age
35 Years to 65 Years
Inclusion criteria
Inclusion criteria: Female sex; 35-65 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
Exclusion criteria: Pregnancy; lactation; smoking; alcohol abuse or drug use; non-menopausal volunteers who do not want to use adequate methods of contraception to avoid pregnancy during the study; non-menopausal volunteers who do not want to undergo a pregnancy test at T1 (before the 1st injection) and T3 (1 month after the 1st injection and before the 2nd injection); variation in body mass index (BMI) (± 1) during the study period; performing aesthetic treatments for the skin of the neck (dermal implants, surgical lifting, botulinum toxin, laser, chemical peels) 6 months before the start of the study; who have had permanent fillings in the past; changes in eating habits, physical activity, cosmetic and neck cleaning products during the month preceding the tests; sensitivity to the product or its ingredients (to be questioned by the investigator during the baseline visit); volunteers whose poor adherence to the study protocol is predictable; participation in a similar study concurrently or in the last 9 months; dermatitis; presence of dermatological diseases in the tested area, such as injuries, scars, malformations; recurrent facial/lip herpes; significant clinical conditions in the tested area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections, severe acne); diabetes; endocrinological diseases; liver dysfunctions; kidney dysfunctions; cardiac dysfunctions; lung diseases; cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the aesthetic performance of the hyaluronic acid (HA)-based dermal filler Profhilo®, injected using the bioaesthetic points technique (“BAP” technique) in women aged 35 to 65 with apparent roughness and flaccidity of the neck. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate tolerance and efficacy through data compilation and self-satisfaction questionnaire. | — |
Countries
Brazil
Contacts
Public ContactAda Almeida
For Trials Pesquisa Clínica Ltda
Outcome results
None listed