Medevu Folica™ 2 ml

1. Contraindications

Do not use Medevu Pro™ Textura if the patient:

- Has known hypersensitivity or allergy to any ingredient, including Propylene Glycol or Chlorphenesin (recognized contact sensitizers).

- Has broken, infected, actively inflamed, or acutely irritated skin at the treatment site.

- Has active or suspected skin malignancy, or unexplained or suspicious lesions at the intended treatment site.

- Has skin lesions less than 3 months old at the treatment site, including recent stretch marks (striae rubrae, red or purple in appearance), recent scars, recent post-surgical scars, or actively healing wounds.

- Has a documented history of keloid or hypertrophic scarring, as controlled skin stimulation may trigger new lesion formation in susceptible individuals.

- Has active herpes simplex (cold sore) outbreak, or a history of recurrent herpes simplex at the treatment site without appropriate antiviral prophylaxis.

- Has an active bacterial, viral, or fungal skin infection at or near the treatment site.

- Has a known bleeding disorder or coagulation abnormality

- Is pregnant or breastfeeding (safety in pregnancy and lactation has not been established).

- Is under 18 years of age (safety and effectiveness in this population have not been established).

- Is currently receiving chemotherapy, radiation therapy, or other treatments known to impair wound healing Diabete.

- Has any condition that impairs wound healing Autoimmune disorders.

2. Precautions

The following conditions require clinical assessment by the treating professional before proceeding:

- Current use of blood-thinning medications or anticoagulants.

- Recent laser resurfacing, chemical peels, or other resurfacing procedures (within 4 weeks).

- Recent use of isotretinoin such as Accutane® (within 6 months).

- Immunocompromised status Recent facial injectable procedures such as neuromodulators or dermal fillers (within 2 weeks).

- Active or recently treated inflammatory skin conditions such as acne, rosacea, eczema, or psoriasis at the treatment site.

- Recent significant sun exposure, tanning, or sunburn at the treatment site.

- Lesions between 3 and 6 months old, particularly post-surgical scars, may require clinical assessment to determine treatment readiness. Post-surgical scars generally require a minimum of 6 months of healing before treatment.

3. Usage

For professional use only. Do not self-administer.

1. Cleanse and prepare the treatment area.

2. Open a sterile, single-use vial immediately before treatment; dispense into the sterile serum cup supplied, as required by the treatment device.

3. Administer using the Medevu Precision Needling System or another professional needling device with needle configuration appropriate for the treatment indication. Nue Conceal recommends needle configurations with inter-needle spacing of less than 0.5 mm for optimal microchannel serum delivery.

Treatment planning: Assess lesion maturity before initiating treatment. Fresh stretch marks (still red or purple in color) and recent scars are typically not ready for treatment. Optimal results are achieved when treating fully matured lesions (typically 3 months or older for stretch marks, 6 months or older for post-surgical scars).

Most patients require 2–4 treatment sessions, spaced approximately 4–6 weeks apart. Discard any unused product immediately after treatment.

4. Aftercare

Proper aftercare is essential to support healing and achieve the best possible results. Immediately after treatment (first 24 hours):

- Do not wash the treated area.

- Avoid touching the treated skin.

- Do not apply any products to the treated area other than Medevu Pro™ Textura Aftercare.

During the healing period (minimum 7 days):

- Apply Medevu Pro™ Textura Aftercare twice daily morning and night for a minimum of 7 days. Do not apply any other product to the treated area during this 7-day healing period.

This includes but is not limited to:

- Moisturizers, serums, or creams not specifically approved by your treating professional. -

Makeup or foundation.

- Sunscreens other than those recommended by your treating professional Retinoids, glycolic acids, salicylic acids, benzoyl peroxide, or exfoliating products.

- Active skincare ingredients such as vitamin C serums, alpha hydroxy acids, or beta hydroxy acids - Essential oils, natural remedies, or home-prepared treatments.

- Any prescription or over-the-counter topical medications not approved by your treating professional.

During the same 7-day period also avoid:

- Direct sun exposure and tanning beds - Swimming pools, hot tubs, saunas, steam rooms, and hot showers.

- Strenuous exercise or activities that cause excessive sweating.

- Picking, scratching, or exfoliating peeling skin, allow it to shed naturally.

Sun protection: Once your treating professional confirms it is safe to introduce sunscreen (typically after the initial healing period), use a broad-spectrum sunscreen (SPF 30 or higher) whenever the treated area is exposed to sunlight. Sun exposure during and after healing may cause hyperpigmentation.

Full recovery: Complete skin recovery typically occurs within 7–14 days depending on treatment depth and individual healing response. Your normal skincare routine may be resumed after 7–10 days or as advised by your treating professional.

Ongoing maintenance (optional): Continued daily use of Medevu Pro™ Textura Aftercare beyond the initial 7-day healing period may help support long-term skin quality and maintain treatment results.

5. Side Affects

Proper post-treatment care is essential to minimize side effects and support optimal skin recovery. All patients should follow the Aftercare instructions provided by the treating professional and use only Medevu Pro™ Textura Aftercare on the treated area during the healing period.

Common (usually resolve within several days to two weeks): 

- Redness at the treatment site.

- Mild swelling.

- Tenderness or discomfort.

- Temporary itching, particularly during the peeling phase.

- Dryness and mild flaking.

- Peeling of treated skin as part of the natural healing process.

- Temporary skin tightness.

- Small pinpoint scabs or dry patches during healing.

Less common (may persist for several weeks):

- Bruising at the treatment site.

- Temporary skin discoloration.

- Acne flare in acne-prone individuals.

- Prolonged redness lasting more than one week.

- Mild fever within 24–48 hours of treatment, particularly following larger treatment areas.

- Temporary post-inflammatory hyperpigmentation (darkening of treated skin), particularly in patients with medium to dark skin tones. This typically resolves within 1–3 months as the skin completes its healing cycle.

Rare but serious:

- Bacterial, viral, or fungal infection at the treatment site.

- Allergic reaction to product ingredients.

- Delayed wound healing Persistent pain beyond the expected recovery period.

- Worsening of existing scars or formation of new hypertrophic or keloid scarring.

- Persistent hyperpigmentation lasting more than 6 months.

- Permanent skin discoloration or texture changes.  

Seek immediate medical attention if the patient experiences: 

- Difficulty breathing, throat tightness, or facial swelling suggestive of anaphylaxis.

- Severe or worsening swelling.

- Fever above 101°F (38.5°C) or fever lasting more than 48 hours Pus or increasing discharge from the treatment site.

- Severe or worsening pain.

- Widespread rash or hives.

- Severe itching accompanied by blistering.

- Signs of spreading infection (increasing redness, warmth, or red streaks extending from treatment site) If severe itching or blistering occurs, discontinue all aftercare products immediately and seek medical attention.

6. Interactions

Before treatment, assess whether the patient is currently using any medications or treatments that may affect skin healing, bleeding, inflammation, or treatment response, including:

- Topical retinoids.

- Corticosteroids.

- Anticoagulants or blood-thinning medications.

- Immunosuppressive medicines.

- Prescription acne medications.

- Treatment may be postponed if other skin procedures have recently been performed at the treatment site.

Medevu Research

Hegenheimermattweg 167A

4123 Allschwil Switzerland

Email: support@medevu.com

Website: www.medevu.com