Evaluation of Efficacy and Safety of Profhilo® Structura for the Correction of Acne Scars of the Face
Acne Scars - Mixed Atrophic and Hypertrophic, Ice Pick Scars, Rolling Scars
About this trial
This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic focused on measuring Acne scars, Hyaluronic acid, Hybrid Cooperative Complexes, Profhilo Structura, Ice pick Scars, Rolling scars, Boxcar scars
Eligibility Criteria
Inclusion Criteria: caucasian subjects of both sexes; age >18years asking for acne scars treatment; presenting acne scars (ice picks, rollings, boxcars); available and able to return to the study site for the post-procedural follow-up examinations; agreeing to present at each study visit without make-up; accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products; accepting not to expose their face to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study, without appropriate sun protection; accepting to sign the Informed consent form. Exclusion Criteria: Dependent on the volunteers' characteristics: smokers; performing in the 6 month before the trial beginning HA injections, radiofrequency treatment, toxin treatment; contraindication or know allergy to the devices' components or to the treatment; participation in a similar study actually or during the previous 3 months known pregnancy occurrence of pregnancy during the study Dependent on a clinical condition: Dermatological disease: Dermatitis; presence of cutaneous disease on the tested area,different from those under study recurrent facial/labial herpes; clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne). Dependent on a clinical condition: General disease: Diabetes, coagulation disorders, connective tissue disorders, lipodystrophy or other systemic disease; HIV and/or immunosuppressive disease; cancerous or precancerous lesions in the either right or left midface; severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies; alcohol or drug abusers; Dependent on a pharmacological treatment: Anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with except of contraceptive or hormonal treatment starting more than 1 year ago); assumption of drugs able to influence the test results in the investigator opinion. The use of other drugs, not mentioned above, can be authorized by the Investigator. The trade name, the dosage, the start and stop date of the therapy will be reported on Case Record Form (CRF).
Sites / Locations
- DERMING S.r.l., Clinical Research and Bioengineering InstituteRecruiting
Arms of the Study
Arm 1
Experimental
Profhilo® Structura treatment group
Treatment of acne scars of the face by using a subcision+injection technique: the needle (25 G) or cannula (25 G) (wider areas are treated with the cannula) is inserted into the skin and made to move with a back-and-forth motion in order to detach scar collagen bundles. Then 1 syringe (2 ml) of Profhilo® Structura is injected. Day 0: Information and consent form provided, Clinical assessment, Digital clinical pictures, Instrumental assessment, Profilometry measurement. First treatment of Profhilo® Structura (refer to study protocol). Day 30 (1 month after day 0): Clinical assessment, Digital clinical pictures, Instrumental assessment, Profilometry measurement. Second treatment of Profhilo® Structura (refer to study protocol). Day 120 (4 months after day 0): Clinical assessment, Digital clinical pictures, Instrumental assessment, Profilometry measurement. NO treatment, Self-evaluation questionnaire.