Open, Non-comparative Study to Evaluate the Performance and Safety of the Medical Device Plenhyage® (Polymerized Polynucleotides Dermal Filler) in the Correction of Wrinkles and Improving the Skin Tones and Irregularities (Atrophies) of the Skin Surface in Neck, Abdomen, Thighs, and Buttocks
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wrinkle
- Sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Wrinkle Severity Rating Scale score evaaluated by the Investigator
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The Research Question of the present study is the following: in a population of men and women affected by face wrinkles and skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks, will Plenhyage® significantly decrease the appearance of treated areas, results observed after 8 and 12 weeks?
Detailed Description
Open, non-comparative, interventional, multicenter study with the total number of screened subjects of 66 (60 evaluable subjects +6 potential screening failure): * 20 patients will be administered Plenhyage® thin for the treatment of mild wrinkles; * 20 patients will be administered Plenhyage® medium for the treatment of moderate wrinkles; * 20 patients will be administered Plenhyage® strong for improving the skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks;
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men or women with age ≥ 30 and ≤ 67 years;
- •Subjects presenting a score of 2 (mild facial wrinkles) for Plenhyage® thin, 3 (moderate facial wrinkles) for Plenhyage® medium on the Wrinkles Severity Ranking Scale (WSRS) seeking skin imperfections treatment;
- •Subjects presenting a ANA score \< 5 seeking treatment for defect and irregularities (atrophies) of the skin surface in neck, abdomen, thighs or buttocks for Plenhyage® strong;
- •Subjects who agree to discontinue all dermatological treatment and procedures during the study.
- •Subjects willing to provide signed informed consent to clinical investigation participation.
- •Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
Exclusion Criteria
- •Use of aspirin and antiplatelet agents a week prior to treatment;
- •Subjects with history of allergy or hypersensitivity to polymerized polynucleotides or to other ingredients of the dermal filler or hypersensitivity skin reaction to the investigational device based on intradermal test results at visit
- •Subjects with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma etc.;
- •Subjects presenting bleeding disorders in the past or present;
- •Subjects taking or having indications for anticoagulant therapy;
- •Use of concomitant treatments or procedures aimed to improve skin rejuvenation over the last six months before the clinical investigation enrolment, such as chemical peeling, dermabrasion, laser resurfacing;
- •Subjects suffering from infectious diseases including herpes simplex virus infection, active hepatitis or human immunodeficiency virus;
- •Subjects suffering from eczema, acne and keloids;
- •Subjects with any cutaneous manifested infection, disease or alteration;
- •Subjects at risk in term of precautions, warnings and contra-indications referred in the package insert of the clinical investigation device;
Outcomes
Primary Outcomes
Wrinkle Severity Rating Scale score evaaluated by the Investigator
Time Frame: 12 weeks
The WSRS score performed by Investigator have been chosen as a primary efficacy outcome to measure the performance of the Plenhyage® thin and medium. The scale has 5 grades: 1 absent, 2 mild, 3 moderate, 4 severe, 5 extreme, where 1 absent represents no visible folds and 5 extreme represent extreme deep and long folds.
Aesthetic Numeric Scale evaluated by the Investigator
Time Frame: 12 weeks
The ANA score will be evaluated on a point scale from 0 to 10 where: 0 - Insufficient 1. - Unsatisfied 2. - Poor 3. - Sufficient 4. - Neutral 5. - Agreed 6. - Satisfied 7. - As requested 8. - Perfect 9. - Harmonic 10. - Highly satisfied The best score for ANA score is 10 highly satisfied and the worst outcome is 0 insufficient
Secondary Outcomes
- WSRS score evaluated by the subject(12 weeks)
- Treatment satisfaction(12 weeks)
- Global Aesthetic Improvement Scale(12 weeks)
- Investigator Global Assessment of Safety(12 weeks)
- Investigator Global Assessment of Performance(12 weeks)
- Patient Global Assessment of Safety(12 weeks)