CROMA POLYPHIL™ EYE

CROMA POLYPHIL™ EYE Product Description

CROMA POLYPHIL™ EYE is a low-concentration polynucleotide-based injectable treatment specifically designed to target the sensitive periocular and delicate facial areas. It uses PN-HPT® (Polynucleotides Highly Purified Technology), which enhances fibroblast activity and promotes skin regeneration while reducing sagging and wrinkles. The product is provided in a 15 mg/2 ml formulation, ideal for improving skin elasticity without excessive pulling or edema. The pack includes a 2 ml pre-filled syringe and two 30G ½ needles for precise application.

CROMA POLYPHIL™ EYE Key Features and Benefits

• Rejuvenation for Sensitive Areas: Specifically formulated for delicate skin, such as the periocular region, addressing concerns like wrinkles, crow’s feet, and sagging.
• Efficacy Confirmed by Studies: Over 90% of patients reported noticeable improvement in fine wrinkles and overall skin quality, supported by 3D skin analysis (ANTERA 3D).
• Multi-functional Benefits:
  • Skin tightening and lifting in the periocular area.
  • Improved skin structure and elasticity.
  • Acts as a Skin Enhancement Technique (SET) for better results when combined with other aesthetic procedures like fillers, lasers, or surgery.
• Safety Profile: Designed for optimal fibroblast stimulation without causing adverse effects like edema.

CROMA POLYPHIL™ EYE Composition

• Active Ingredient: Polynucleotides (PN) in a 15 mg/2 ml concentration.
• PN-HPT® Technology: Enhances skin regeneration by stimulating fibroblasts and remodeling areas with high fibrous content.
• Designed to optimize the balance between efficacy and safety for delicate skin.

CROMA POLYPHIL™ EYE Intended Purpose / Indications

CROMA POLYPHIL™ EYE is intended for:

• Skin rejuvenation: Improving the quality, elasticity, and texture of sensitive and aging skin in the periocular region.
• Wrinkle reduction: Targeting superficial wrinkles and fine lines, particularly around the eyes.
• Anti-aging prevention: Suitable for younger patients to delay aging and for mature patients to restore skin vitality.
• Preparation for aesthetic treatments: Acts as a primer for enhancing the efficacy of subsequent procedures, including fillers, lasers, and needling.

CROMA POLYPHIL™ EYE Injection and Treatment Areas

• Treatment Areas:
  • Periorbital area (around the eyes).
  • Arches of the eyebrows.
  • Other delicate facial regions prone to sagging or wrinkles.
• Injection Depth: Intradermal.
• Protocol:
  • Dosage: 1-2 ml per session.
  • Frequency: One session every 14 to 21 days for a total of 3-4 sessions.
  • Technique: Serial puncture or linear retrograde technique, with injection points spaced 0.5–1 cm apart.

CROMA POLYPHIL™ EYE Reconstitution and Preparation Guidelines

• Pre-filled syringes eliminate the need for reconstitution.
• Ensure aseptic handling during preparation.
• Follow standard sterile techniques for injectable treatments.

CROMA POLYPHIL™ EYE Administration and Dosage

• Administer 1-2 ml per session, intradermally, using the provided 30G ½ needles.
• Ensure even distribution by following a precise injection pattern.
• Monitor the patient during the procedure for any immediate adverse reactions.

CROMA POLYPHIL™ EYE Storage Instructions

• Temperature: Store between 2°C and 25°C.
• Precautions: Avoid exposure to light and freezing temperatures.
• Ensure the product remains in its original packaging until use.

CROMA POLYPHIL™ EYE Contraindications

• Allergies to polynucleotides or other components of the formulation.
• Active skin infections or inflammation in the treatment area.
• Patients with autoimmune disorders, pregnancy, or breastfeeding should avoid treatment.

CROMA POLYPHIL™ EYE Precautions and Warnings

• Risk of vascular complications if injected into blood vessels.
• Ensure proper injection depth to avoid adverse effects.
• Combine with other aesthetic treatments cautiously to prevent potential interactions.

CROMA POLYPHIL™ EYE Post-Treatment Care

• Recommendations:
  • Avoid UV exposure, makeup, and extreme temperatures for 24-48 hours post-treatment.
  • Maintain a clean treatment area to reduce the risk of infection.
• Encourage patients to hydrate adequately to support skin recovery.

CROMA POLYPHIL™ EYE Side Effects and Adverse Reactions

• Common side effects: Redness, swelling, and minor bruising at the injection site.
• Severe reactions: Rare but may include hypersensitivity or vascular complications.
• Report unexpected adverse events to the manufacturer or regulatory authority.

CROMA POLYPHIL™ EYE Patient Eligibility

• Eligible Patients:
  • Individuals seeking to improve skin quality and reduce signs of aging in delicate areas.
  • Patients without contraindications or underlying health conditions that could impact treatment.
• Ineligible Patients:
  • Those with severe allergies, skin infections, or certain chronic conditions.

CROMA POLYPHIL™ EYE Follow-Up and Maintenance

• Initial Treatment: Three to four sessions spaced 2-3 weeks apart.
• Maintenance: Follow-up treatments every 6-12 months to sustain results.

CROMA POLYPHIL™ EYE Manufacturer and Regulatory Information

• Manufacturer: CROMA Pharma GmbH.
• Complies with CE marking standards for medical devices.
• Batch numbers and expiration dates are provided on individual packaging.

CROMA POLYPHIL™ EYE FAQ

1. Who is the ideal candidate for CROMA POLYPHIL™ EYE?
   • Patients seeking periocular rejuvenation and prevention of aging in delicate areas.
2. How soon can results be seen?
   • Improvements in skin quality are noticeable within 30 days post-treatment.
3. Is the procedure painful?
   • Minimal discomfort due to the use of fine needles and precise techniques.
4. What is the downtime?
   • Most patients can resume normal activities within 24-48 hours.