1. WHAT CAN BE TREATED?

The treatment is always carried out according to the instructions for use.

The Hygiene modules and devices (safety needle cartridge and medical) were developed for the following medical purpose:

• Percutaneous collagen induction (PCI) via minimally invasive wounding of the dermis by needle penetration (microneedling).

The microneedling treatment minimally invasively punctures the epidermis and dermis without the skin suffering open wounds. This allows the epithelial function to be restored within a very short time, which results in a very short regeneration phase.

Applications for microneedling for percutaneous collagen induction (PCI) are:

• Treatment of acne scars

2. WHAT CANNOT BE TREATED?

The treatment is always carried out according to the instructions for use.

Microneedling treatment should not be used in the following cases: 

• Haemophilia/bleeding disorder
• Uncontrolled Diabetes mellitus
• Treatment of eyeballs
• Treatment of mucous membranes, for example mucous membranes of the oral cavity or the inner eye area.
• Treatment of skin areal with dermatosis, e.g. skin tumor, keloid or extreme keloidal tendency, solar keratosis, warts or birthmarks)
• HIV and Hepatitis

In the following cases, a microneedling treatment should not be used temporarily until the normal state of health has been restored:

• Acute intake of blood thinning agents, e.g. warfarin, heparin, acetyl-/salicylic acid
• Acute chemotherapy or cancer, radiotherapy or high-dosed corticosteroid therapy
• Systemic infections or acute local skin infections
• Any kind of active acne
• Allergy to topical anesthetics (local anesthesia)
• Pregnancy and lactation/breastfeeding

Temporary local non-applicability exists in the following cases:

• Eczema, exanthema or open wounds
• Scars less than six months old
• Skin areas after plastic surgery less than twelve months ago, for example lifting, cheekbone correction, skin smoothing, etc.
• Skin areas after filler injections less than six months ago, e.g. hyaluronic acid injections etc.

3. HOW DOES THE TREATMENT PROCEED? 

The treatment is always carried out according to the instructions for use.
The following points must be observed in advance of the treatment:

• No make-up on the day of treatment
• Shaving the evening before treatment to avoid skin irritation

Essentially, a treatment consists of the following steps:

1. Cleaning the face: 5 minutes
2. Effect of a superficial anaesthetic ointment: 30 minutes
3. Cleaning the face again: 5 minutes
4. Skin disinfection: 5 minutes
5. Treatment with the Microneedling device: approx. 15–30 minutes, depending on the size of the treatment area
   1. during the treatment the upper skin layers (epidermis and dermis) are administered with very multiple, very small microscopic holes
   2. experience reports describe that it feels as if an electric toothbrush were gliding over the skin or as if the skin were rubbed with sandpaper
   3. the treatment is carried out until a homogeneous treatment result is achieved
6. Cleaning the face: 5 minutes
7. Applying a skin-soothing care cream

This results in a total treatment time of approx. 1–1.5 hours. 

4. RISKS AND SIDE-EFFECTS

The following side effects have been reported in clinical literature:

Common:

• Pain on the first day after application
• Occurrence of inflammatory reactions, haematomas, erythema and oedema in the first three to five days after the treatment
• Occurance of skin irritations (e.g. itching or overheating) which normally subside within the first 12 to 48 hours after treatment

Rare:

• Temporary occurance of hyperpigmentation with body´s own pigments, especially for darker skin types, which disappears completely after a few weeks
• In cases of careless skin cleansing, the formation of scab, small pustules or milia (milia) have been reported.
• Retinoid reaction (slight redness up to peeling of the skin)

Further information

During the first days after the treatment, the skin is sensitive to external influences such as sun-light. Avoid prolonged, direct sunlight. If you so happen to be in the sun, use sunscreen every 2 hours.

The following medications should not be taken during the treatment period:

• blood thinning agents, e.g. warfarin, heparin, salicylic acid
• chemotherapy, radiotherapy or high-dosed corticosteroid therapy

Please inform the doctor of any discomfort, illness or injury that may occur during the course of Microneedling treatments. If these are serious, please inform the attending physician immediately, if necessary by telephone.

5. WHAT OTHER TREATMENT OPTIONS ARE THERE?

Your doctor will inform you about the alternative treatment methods.
Here you get an initial overview of possible further treatment options with advantages and disadvantages.
Note: The listed alternative treatment options are also available if combined with microneedling or to optimize the therapeutic result! This is an individual user´s decision, depending on the initial result. 

6. WHO CAN I CONTACT IF I HAVE FURTHER QUESTIONS?

Consultations are available at the test site

You always have the opportunity for further consultations with the attending physician to answer further questions. Also questions concerning your rights and duties as a patient will be answered gladly.

The test product and the comparative therapy as well as the nature, significance, risks and scope of the observational study were explained in detail and  comprehensibly. I have also read and understood the text of the patient  information and the data protection declaration printed below. I had the  opportunity to talk to the doctor about the implementation of the treatment. All my questions were answered satisfactorily.