Description
PROFHILO BODY PACK IBSA is a CE-marked Class III medical device kit from IBSA Derma designed as a global solution for treating sagging skin and laxity on the body. The pack combines an injectable hyaluronic acid bioremodeling treatment with topical cosmetic products to enhance and maintain results over time. Each kit contains 4 products: two pre-filled syringes of PROFHILO BODY (3 ml each, 3.2% – 96 mg/3 ml total hyaluronic acid in the form of hybrid cooperative complexes of high and low molecular weight HA), one box of PROFHILO FIGURA BODY PATCH (4 sterile, single-use patches) and one PROFHILO FIGURA BODY CREAM (150 ml multi-active remodelling and toning cosmetic cream in an airless bottle). The protocol involves two in-clinic injectable sessions one month apart, with immediate post-treatment application of the soothing, moisturising patches and at-home use of the body cream between and after sessions to prolong and optimise improvements in skin firmness, elasticity, hydration and overall quality on areas such as the arms and abdomen.
Bnefits
- Comprehensive body skin laxity protocol combining injectable hyaluronic acid bioremodeling with targeted topical homecare (patches and cream) in a single kit.
- Includes two PROFHILO BODY injectables (3 ml each) containing 3.2% – 96 mg/3 ml of ultrapure hyaluronic acid (48 mg high molecular weight + 48 mg low molecular weight) in stable cooperative hybrid complexes (HCC) created with NAHYCO thermal technology, without BDDE cross-linking agents.
- Designed specifically for treating sagging body skin and loss of turgor, particularly recommended for the brachial (upper arm) area and abdomen, and also usable on other laxity-prone regions.
- Injectable component provides deep bioremodeling, improving tissue hydration, elasticity and structure, and helping to remodel ageing and lax skin rather than simply filling isolated defects.
- PROFHILO FIGURA BODY PATCH offers a sterile, post-procedure soothing and moisturising treatment, helping to reduce redness and increase hydration after aesthetic injections.
- PROFHILO FIGURA BODY CREAM is a multi-active remodelling and toning cosmetic cream with high- and low-molecular-weight hyaluronic acids and Matrixyl 3000, clinically shown to increase moisturisation and elasticity while improving skin cohesion and tone.
- Structured treatment program: two injectable sessions 30 days apart with post-session patch application and continued use of the cream at home to extend and stabilise the aesthetic outcome.
- High safety and tolerability profile when used by qualified physicians according to the instructions for use, with dermatologically tested patches and cream suitable for sensitive skin.
Indications
- Bioremodeling treatment of body skin laxity and loss of firmness, particularly in the brachial (upper arm) and abdominal areas, and other areas affected by sagging skin.
- Correction and improvement of natural and induced skin depressions and roughness associated with skin ageing, dehydration and reduced dermal elasticity.
- Support of dermal tissue repair processes in the presence of superficial scars (e.g. post-traumatic or acne-related), according to the injectable device’s intended use.
- Soothing and moisturising care of treated body areas following aesthetic procedures, via PROFHILO FIGURA BODY PATCH.
- Remodelling, toning and hydrating care of body skin, with improvement of elasticity and cohesion, via PROFHILO FIGURA BODY CREAM for at-home maintenance.
Composition
- PROFHILO BODY injectable (per 3 ml pre-filled syringe): 48 mg high molecular weight hyaluronic acid (H-HA) + 48 mg low molecular weight hyaluronic acid (L-HA) as sodium hyaluronate (total 96 mg HA in 3 ml, 3.2% concentration) in a buffered sodium chloride solution (sodium chloride, sodium phosphate, water for injections).
- PROFHILO FIGURA BODY CREAM (150 ml cosmetic product): multi-active body cream containing high and low molecular weight hyaluronic acids in high concentration and Matrixyl 3000 peptide complex, along with emollients, humectants and excipients to provide a silky, fast-absorbing, nourishing texture (full INCI list provided on product packaging).
- PROFHILO FIGURA BODY PATCH (box of 4): sterile, single-use hydrogel-based patches containing cooperative hybrid complexes of low and high molecular weight hyaluronic acid (total 64 mg per patch: 32 mg L-HA + 32 mg H-HA), formulated for cutaneous use to soothe, moisturise and support the skin after aesthetic treatments.
Packaging
- 1 x PROFHILO BODY PACK IBSA outer carton containing:
- • 2 x PROFHILO BODY pre-filled syringes, each 3 ml (3.2% – 96 mg/3 ml HA: 48 mg H-HA + 48 mg L-HA), each supplied with 2 sterile Terumo needles 29G x 13 mm and traceability labels.
- • 1 x PROFHILO FIGURA BODY PATCH box containing 4 sterile, single-use cosmetic body patches in individual sachets.
- • 1 x PROFHILO FIGURA BODY CREAM multi-active remodelling and toning cosmetic cream in a 150 ml airless bottle.
- Each injectable syringe is supplied sterile in a blister pack with instructions for use (IFU) and implant card; patches and cream include cosmetic product leaflets and labelling with full ingredient lists and usage directions.
Usage
- The PROFHILO BODY injectable component is a Class III medical device intended for intradermal/superficial subcutaneous injection exclusively by qualified doctors or appropriately trained healthcare professionals in a medical setting.
- Before use of the injectables, verify integrity of the blister and outer packaging, check expiry date, and ensure the syringe and needles are sterile and unopened. Do not use if packaging is damaged or if the solution is cloudy or contains particulates.
- Attach the supplied 29G needle to the Luer-lock of the PROFHILO BODY syringe under strict aseptic conditions, expel any air bubble if necessary, and inject at room temperature, following the instructions for use.
- Recommended injectable protocol: an initial cycle of two treatment sessions using PROFHILO BODY 3 ml, typically with a 30-day (one month) interval between sessions. In many protocols, 3 ml is divided into 10 Bio Aesthetic Points (BAP) on the brachial and/or abdominal areas (0.3 ml per point) at deep dermal/subcutaneous level, with gentle massage after injection. The exact scheme should be adapted to patient morphology and clinical judgement as outlined in the IFU.
- Do not inject intravascularly, intramuscularly, into tendons, into mammary tissue or into areas with active inflammation or infection. Do not mix PROFHILO BODY with other products in the same syringe. Do not use in conjunction with medium-deep peels or laser resurfacing in the same session in the treated area.
- After injection, gently massage the treated areas to aid even distribution and advise the patient to avoid exposure to intense heat or cold, saunas, steam baths, tanning beds and direct UV radiation for 3–5 days; recommend the use of high-SPF sun protection on exposed treated areas.
- Immediately post-procedure, apply PROFHILO FIGURA BODY PATCH to the treated area as recommended (single-use, sterile patches) to soothe, cool and intensively moisturise the skin. Leave on for the time specified in the cosmetic leaflet (e.g. around 2 hours), then remove and discard; do not reuse patches.
- Between injectable sessions and after the second session, instruct patients to use PROFHILO FIGURA BODY CREAM at home on the treated body areas, typically once or twice daily, massaging gently until fully absorbed, to help maintain and enhance treatment results over time by improving hydration, elasticity and skin tone.
- Patches and cream are for external cutaneous use only; avoid contact with eyes and mucous membranes. In case of accidental contact, rinse thoroughly with water. Discontinue use and consult a healthcare professional if irritation or persistent redness occurs.
- Discard any residual injectable product after single-patient use, and dispose of syringes, needles, patches and packaging according to local regulations for medical sharps and cosmetic waste. Do not resterilise and do not reuse the injectables.
Contraindications
- Known hypersensitivity or allergy to hyaluronic acid (sodium hyaluronate) or any of the excipients in the injectable solution.
- Known hypersensitivity to any ingredient in the PROFHILO FIGURA BODY CREAM or PATCH (patients with a history of cosmetic product allergies should be evaluated carefully and may require patch testing).
- Presence of active skin disease, infection or inflammation (e.g. dermatitis, bacterial or viral infection such as herpes) at or near the proposed injection or patch/cream application sites.
- Pregnancy and breastfeeding: use of PROFHILO BODY injectables is not recommended due to lack of sufficient clinical data in these populations.
- Autoimmune diseases or patients receiving immunosuppressive therapy, unless the prescribing physician judges that the benefits outweigh potential risks.
- Severe coagulation disorders or use of anticoagulant/antiplatelet therapy that significantly increases bleeding risk, without appropriate medical assessment.
- Do not use the injectable product in association with medium-deep chemical peels or laser resurfacing in the same treatment area and session.
- Do not inject into blood vessels, muscles, tendons, mammary tissue, areas with permanent fillers/implants or areas showing significant structural compromise.
- Patches and cream should not be applied to broken, ulcerated or severely irritated skin unless specifically recommended by a healthcare professional.
Adverse Effects
- For PROFHILO BODY injectable: common, usually transient injection-site reactions such as pain, tenderness, erythema (redness), swelling/oedema, warmth, pruritus (itching), burning sensation, small haematomas or bruising and palpable lumps at the injection points, typically resolving spontaneously within a few days.
- Less common reactions may include prolonged swelling, local inflammatory responses or induration; these should be evaluated by the treating physician and managed according to clinical judgement.
- As with all injectable hyaluronic acid devices, rare but serious complications can include infection, abscess formation, vascular occlusion and, in extreme cases, local tissue necrosis if inadvertent intravascular injection or significant vascular compression occurs.
- For PROFHILO FIGURA BODY PATCH: generally well tolerated; potential mild, temporary local reactions such as redness, slight warmth, transient itching or irritation at the application site, especially in sensitive individuals. Clinical data report increased hydration and reduced redness with good tolerability.
- For PROFHILO FIGURA BODY CREAM: occasional mild skin reactions such as transient redness, tightness or irritation may occur in susceptible individuals; cosmetic clinical studies report improvements in moisturisation, elasticity and perceived smoothness and firmness with dermatological testing on sensitive skin.
- Any unexpected or persistent adverse effect should prompt discontinuation of treatment and assessment by the healthcare professional; serious incidents associated with the medical device should be reported to the manufacturer and/or competent authority as required by local regulations.
Storage Conditions
- PROFHILO BODY injectable syringes: store below 25 °C in a dry place away from direct heat and sunlight. Do not freeze. Keep in original blister and carton until use to maintain sterility and protect from light.
- Do not use the injectable product after the expiry date indicated on the packaging. Once a blister is opened, use the syringe immediately and discard any unused product; the device is single use and must not be resterilised or reused.
- Store PROFHILO FIGURA BODY CREAM at typical room temperature away from excessive heat, direct sunlight and humidity. Keep the airless bottle tightly closed when not in use and observe expiry date and period-after-opening (PAO) symbol on the packaging.
- Store PROFHILO FIGURA BODY PATCH in its original box and individual sachets at room temperature, in a dry place away from direct sunlight. Use each patch immediately after opening its sachet and discard after single use.
- Keep all kit components out of the reach and sight of children.
Duration
Standard protocol consists of an initial cycle of two PROFHILO BODY injectable sessions 30 days apart, with post-session patch application and daily use of PROFHILO FIGURA BODY CREAM between and after sessions. Clinical improvements in hydration, elasticity and skin laxity typically persist for several months (often around 6 months), after which maintenance injectable treatments may be performed every 2\u20133 months or according to the physician\u2019s assessment and patient needs.
Onset
Hydration and skin comfort from the patch and cream are noticeable from the first applications, with measurable increases in skin moisturisation and reductions in redness reported within hours to days. Visible improvements in body skin texture, firmness and laxity from the injectable PROFHILO BODY component generally become more evident over the weeks following treatment, typically after the second session (around 4\u20138 weeks from the start of the protocol), with continued gradual enhancement over subsequent weeks.
