Skin Laxity, Skin Roughness
Conditions
Keywords
Skin laxity, Skin roughness, Profhilo Body, Hyaluronic Acid, Hybrid Cooperative Complexes
Brief summary
People lose collagen all over the body, not just in the face; skin roughness and laxity of the dorsum of the hands can result from chrono and photo-aging. This skin roughness and laxity can range from very mild to severe; injection procedures can provide new tone and firmness to the skin of the hand dorsum. Dermal fillers are the most used non-permanent injectable materials available today to correct skin flaccidity and roughness on the dorsum of the hands. They give immediate aesthetic effect due to elastic gel matrix injected and impart longer term effects due to bio stimulation, promoting new collagen formation. The objective of this study is to investigate the aesthetic performance of the Hyaluronic acid (HA)- based dermal filler Profhilo® Body injected by a blunt tip microcannula (25G or 22G, preferably 22G), with fanning technique through a single entry point performing 5 passages and injecting 0,3 ml per passage, 1,5 ml for each hand. Volunteers of both sexes, aged 18-65 years with mild-moderate skin roughness and laxity at the level of hand dorsum are to be treated.
Detailed description
Open, monocentric. 3 visits, 55 subjects. Primary endpoint of the study is the evaluation of performance and tolerance of Profhilo Body (3ml) treatment in the back of the hands ( or dorsum of the hands). Secondary endpoint is self-assessment questionnaire by both doctors and volunteers. Profhilo® Body (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 3.25 ml non-pyrogenic pre-filled syringe, containing 3 ml of 3.2% hyaluronic acid for intradermal use (48 mg H-HA + 48 mg L-HA) dissolved in 3 ml of saline buffered sodium chloride. - IBSA Farmaceutici Italia S.r.l. - ITALY. The principle component is cross-linked Hyaluronic Acid of non-animal origin, produced by bacterial fermentation.
Interventions
DEVICEProfhilo® Body
Dosage form: Profhilo® Body (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 3.25 ml non-pyrogenic pre-filled syringe, containing 3 ml of 3.2% hyaluronic acid for intradermal use (48 mg H-HA + 48 mg L-HA) dissolved in 3 ml of saline buffered sodium chloride.
Sponsors
Derming SRL
IBSA Farmaceutici Italia Srl
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking
Intervention model description
55 subjects undergoing Profhilo Body treatment in the back of the hands, 3 visits: Day 0 (treatment) Day 30 (1 month after Day 0 treatment) Day 120 (4 months after Day 0 - follow-up).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Will be included in the study volunteers with the following characteristics: * female and male sex, not necessarily 1:1 ratio; * age 18-65 years; * asking for hands 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 hands; * accepting not to expose their hands to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study, without appropriate sun protection;
Exclusion criteria
* Pregnancy; * lactation; * smokers; * alcohol or drug abusers; * subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study; * Body Mass Index (BMI) variation (± 1) during the study period; * performing non-surgical skin aesthetic procedures for hands in the 6 months prior to the study start; * aesthetic surgical procedure for the hands in the past; * change in the normal habits regarding food, physical activity, cosmetic products and cleansing for the hands 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.) * presence of cutaneous disease on the tested area, as lesions, scars, malformations; * clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, sclerodermia, local infections).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline of Skin density (profilometry) at 30 days and at 120 days post-injection | Day 0, Day 30, Day 120 | A picture of the skin is taken thanks to Primos compact portable device (GFMesstechnik) and a 3D representation is elaborated by Primos software. |
| Change from Baseline of Tissue dielectric constant value of superficial and deep skin layers at 30 days and at 120 days post-injection | Day 0, Day 30, Day 120 | Non-invasive measurements of dielectric constant of the skin and subcutaneous fat by MoistureMeterD (Delfin Technologies, Kuopio - Finland). MoistureMeterD measures the changes in the total water content in the tissue with 0.5mm and 1.5mm probes. |
| Change from Baseline of Photographic evaluation at 30 days and at 120 days post-injection | Day 0, Day 30, Day 120 | 2D pictures of the dorsum of both hands are taken in order to support the aesthetic result assessment |
| Change from Baseline of Skin Roughness and flaccidity at 30 days and at 120 days post-injection | Day 0, Day 30, Day 120 | Visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity) |
| Change from Baseline of Superficial and deep skin plastoelasticity at 30 days and at 120 days post-injection | Day 0, Day 30, Day 120 | Measurement of the principal torsiometric parameters Ue (immediate extensibility), Uf (final extensibility), Uv (viscoelasticity) and Ur (immediate elastic recovery) by the instrument Dermal Torque Meter (Dia-Stron Ltd., UK) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment tolerance questionnaire | Day 30, Day 120 | Self-assessment score: bad; poor; good; excellent |
| Efficacy questionnaire | Day 30, Day 120 | Self-assessment questionnaire regarding skin roughness and laxity of the treated areas, skin suppleness, skin smoothness, skin hydration, skin lifting, contour redefinition/remodeling (score: very marked; marked; medium; light; absent) |
Countries
Italy
Outcome results
None listed