WrinklePlenhyageNCT04650620
Study to Evaluate the Performance and Safety of the Medical Device Plenhyage®
A study testing Plenhyage® thin, Plenhyage® medium and Plenhyage® strong in people with Wrinkle, run by I.R.A. Istituto Ricerche Applicate S.p.A. at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Plenhyage® thin, Plenhyage® medium and Plenhyage® strong
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRomania
- Study dates
- 22 Oct 2020to 2 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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.).
- Subjects with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the study.
- Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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?
Read the 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;
- Conditions
- Wrinkle
- Being tested
- Plenhyage® thin, Plenhyage® medium, Plenhyage® strong
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plenhyage® thinDevice
0.75%
Plenhyage® mediumDevice
2%
Plenhyage® strongDevice
2.5%
| Study group | Role | What they receive |
|---|---|---|
| Plenhyage® thin | Experimental | Plenhyage® thin for the treatment of mild wrinkles; Receives: Device: Plenhyage® thin |
| Plenhyage® medium | Experimental | Plenhyage® medium for the treatment of moderate wrinkles; Receives: 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 Receives: Device: Plenhyage® strong |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- - Unsatisfied
- - Poor
- - Sufficient
- - Neutral
- - Agreed
- - Satisfied
- - As requested
- - Perfect
- - Harmonic
- - Highly satisfied The best score for ANA score is 10 highly satisfied and the worst outcome is 0 insufficient
Measured: 12 weeks
Secondary outcomes (6)
WSRS score evaluated by the subject
The WSRS score performed by subject has been chosen as a secondary 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.
Measured: 12 weeks
Global Aesthetic Improvement Scale
Subjects will evaluate their skin appearance change compared to before the treatment, as follows:
Very Much Improved (1) = Optimal cosmetic result; Much Improved (2) = Market improvement in appearance but not completely optimal. A touch-up would slightly improve the result; Improved (3) = Obvious improvement in appearance from the initial condition, but a touch-up or re-treatment is indicated; No Change (4) = The appearance is essentially the same as the original condition; Worse (5) = The appearance is worse than the original condition.
Measured: 12 weeks
Treatment satisfaction
Treatment satisfaction will be assessed by the subject at 4, 8 and 12 weeks using a 4-point scale: very satisfied, satisfied, moderate and not satisfied;
Measured: 12 weeks
Investigator Global Assessment of Performance
Investigator Global Assessment of Performance (IGAP) Investigator will make photographs at every visit (1, 2, 3, 4 and 5) of the area treated in order to evaluate the performance of the treatment at visit 5 using a 4-point scale: 1= very good performance, 2 = good performance, 3 = moderate performance and 4 = poor performance;
Measured: 12 weeks
Investigator Global Assessment of Safety
Investigator Global Assessment of Safety (IGAS) will be reported using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. IGAS will be evaluated by the Investigator at Final visit (12 weeks), only;
Measured: 12 weeks
Patient Global Assessment of Safety
Patient Global Assessment of Safety (PGAS) will be reported by the subject at the last visit using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. PGAS will be evaluated by the patient at Final visit (12 weeks), only.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start22 Oct 2020
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.
- Sponsor type
- Research network
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650620
- Sponsor's protocol ID
- OPIRA/0419/MD
- Acronym
- Plenhyage
- Status last verified
- Apr 2021
- First submitted
- 25 Nov 2020
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04650620
- Acronym / sponsor ID
- Plenhyage / OPIRA/0419/MD
- Conditions
- Wrinkle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.Research network
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Plenhyage® thin | Experimental | Device: Plenhyage® thinPlenhyage® thin for the treatment of mild wrinkles; |
| Plenhyage® medium | Experimental | Device: Plenhyage® mediumPlenhyage® medium for the treatment of moderate wrinkles; |
| Plenhyage® strong | Experimental | Device: Plenhyage® strongPlenhyage® strong for improving the skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks |
Who may qualify
- Ages
- 30 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plenhyage® thin0.75% | Device | Plenhyage® thin |
| Plenhyage® medium2% | Device | Plenhyage® medium |
| Plenhyage® strong2.5% | Device | Plenhyage® strong |
Primary outcome
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
6 secondary outcomes
WSRS score evaluated by the subject
Time frame: 12 weeks
Global Aesthetic Improvement Scale
Time frame: 12 weeks
Treatment satisfaction
Time frame: 12 weeks
Investigator Global Assessment of Performance
Time frame: 12 weeks
Investigator Global Assessment of Safety
Time frame: 12 weeks
Patient Global Assessment of Safety
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
Related trials for Wrinkle
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Skin Laxity, Wrinkle
Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plenhyage® thin, Plenhyage® medium and Plenhyage® strong in people with Wrinkle, run by I.R.A. Istituto Ricerche Applicate S.p.A. at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrinkle Severity Rating Scale score evaaluated by the Investigator (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.