An Open, Non-comparative Study of the Efficacy and Safety of Treatment of Acne Scars With Restylane Vital Lidocaine
Condition: Acne Scars
MeSH terms: Acne Vulgaris
Intervention: Restylane Vital Lidocaine
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 25 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital
      Lidocaine when acne scars are treated
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 25 to 45 years.

          -  Caucasian with Fitzpatrick skin type I-III.

          -  Must be cooperative and willing to comply with the instructions and procedures.

          -  Provision of signed and dated informed consent to participate in the study.

          -  Presence of depressed facial atrophic acne scars with a diameter of <4 mm according to
             at least SCAR-S score 3 category moderate (i.e. more than half of the face involved).

        Exclusion Criteria:

          -  Icepick scarring or atrophic scars with a diameter of ≥4 mm covering more than 25% of
             the face.

          -  Active acne with inflammatory component.

          -  Post-surgical scars in the face.

          -  History of keloid formation or hypertrophic scars.

          -  Use of isotretinoin within 12 months of the baseline visit.

          -  Use of per oral or topical (facial) substances containing retinoids, bensoyl peroxide,
             alpha-hydroxy acid at a concentration above 10% or beta-hydroxy acid at a
             concentration above 2% or antibiotics within four months of the baseline visit.

          -  Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation
             (e.g. aspirin or other nonsteroidal anti-inflammatory drugs [NSAIDs]), Omega-3 or
             vitamin E seven days before the injection, or a history of bleeding disorders.

          -  Use of anti-inflammatory agents seven days before the injection.

          -  History of radiation or skin tumours including actinic keratosis in the face.

          -  Active skin disease, inflammation or related conditions, such as infection, perioral
             dermatitis, seborrheic eczema and rosacea in the face.

          -  History of or active collagen diseases or autoimmune diseases such as systemic lupus
             erythematous, rheumatic arthritis, skin or systemic sclerosis.

          -  Previous hypersensitivity to HA.

          -  Previous hypersensitivity to lidocaine or other amide-type anaesthetics.

          -  Concomitant treatment with chemotherapy, immunosuppressive agents, immunomodulatory
             therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids
             within 3 months of the baseline visit. (Inhaled corticoids are not an exclusion
             criterion).

          -  Presence of facial hair that may interfere with efficacy evaluations.

          -  Previous tissue augmenting therapy or revitalization treatment in the treatment area
             with HA or collagen, within 12 months of the baseline visit.

          -  Permanent implant or treatment with fillers based on other material than HA or
             collagen in the treatment area.

          -  Laser, e.g. carbon dioxide and Fraxel, dermabrasion or facial light therapy, e.g. IPL,
             in the treatment area within 12 months of the baseline visit.

          -  Chemical peeling in the treatment area within 6 months of the baseline visit.

          -  Previous surgery in the treatment area.

          -  Nicotine use within 6 months before the baseline visit.

          -  Pregnancy or breast feeding.

          -  Participation in any other clinical study within 30 days before inclusion.

          -  Any medical condition that in the opinion of the investigator makes the subject
             unsuitable for inclusion (e.g. severe chronic disease, epilepsy, impaired cardiac
             conduction, severely impaired hepatic function or severe renal dysfunction).

          -  Other condition preventing the subject from entering the study in the investigator's
             opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects
             anticipated to be unreliable or incapable of understanding the study assessment or
             unrealistic expectations of treatment result.

          -  Study staff or close relative of study staff (e.g. parents, children, siblings and
             spouse).