Study to Evaluate the Performance and Safety of the Medical Device Plenhyage®

NCT04650620 | Completed

• 1 other identifier: OPIRA/0419/MD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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?

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (2)

• Wrinkle Severity Rating Scale score evaaluated by the Investigator

  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.

  12 weeks

• Aesthetic Numeric Scale evaluated by the Investigator

  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

  12 weeks

Secondary Outcomes (6)

• WSRS score evaluated by the subject

  12 weeks

• Global Aesthetic Improvement Scale

  12 weeks

• Treatment satisfaction

  12 weeks

• Investigator Global Assessment of Performance

  12 weeks

• Investigator Global Assessment of Safety

  12 weeks

Study Arms (3)

Plenhyage® thin

EXPERIMENTAL

Plenhyage® thin for the treatment of mild wrinkles;

Device: Plenhyage® thin

Plenhyage® medium

EXPERIMENTAL

Plenhyage® medium for the treatment of moderate wrinkles;

Device: Plenhyage® medium

Plenhyage® strong

EXPERIMENTAL

Plenhyage® strong for improving the skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks

Device: Plenhyage® strong

Interventions

Plenhyage® thin DEVICE

0.75%

Plenhyage® thin

Plenhyage® medium DEVICE

2%

Plenhyage® medium

Plenhyage® strong DEVICE

2.5%

Plenhyage® strong

Eligibility Criteria

• Age: 30 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 1.
• 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;
• Subjects with any facial aesthetic surgery in the preceding 12 months before the clinical investigation enrolment;
• Subjects with any active irritation or inflammation in the target areas of injection;
• Subjects who received botulinum toxin A injections in the face in the preceding 6 months;
• Subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits;
• Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception\* during the study, \*Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.).

Sponsors & Collaborators

• I.R.A. Istituto Ricerche Applicate S.p.A.: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

SCM Dr. Rosu

Timișoara, Timiș County, 300425, Romania

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 2, 2020
• Study Start: October 22, 2020
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

RO (1)