Aged SkinPhase 4NCT02403986

An Efficacy and Safety Study Evaluating Treatment Sessions of Restylane Skinboosters Vital Lidocaine in the Face

A Phase 4 study testing Restylane Vital Skinboosters Lidocaine in people with Aged Skin, run by Galderma R&D at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A randomised, multi-centre, parallel-group efficacy and safety study evaluating two and three initial treatment sessions of Restylane Skinboosters Vital Lidocaine in the face. Read more about this study

Who is it for?: Ages 35 to 45 years, women only
Conditions the study is for: Aged Skin
What is being tested?: Restylane Vital Skinboosters Lidocaine
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteGermany
Study dates: Apr 2015to 30 Mar 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 35 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

Provision of signed and dated informed consent to participate in the study.
Non-pregnant, non-breast feeding female aged 35-45 years.
Visible signs of aging in the face
Intent to improve skin hydration, skin structure and the elasticity of the skin using - Restylane Skinboosters Vital Lidocaine.

Who cannot join

Extensively photo damaged and aged skin.
Woman who plan to become pregnant during the course of the study.
Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel.
Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
History of severe or multiple allergies manifested by anaphylaxis.
History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation, Omega-3 or Vitamin E within 10 days before study treatment

Show all 22Show fewer

Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids (inhaled corticoids are allowed) within three months before study treatment.
Previous tissue augmenting therapy or contouring with permanent filler or fat-injection in the face.
Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler, neurotoxin or revitalisation preparations (e.g. Hyal System or Restylane Skinboosters) in the face within 12 months before study treatment.
Previous tissue revitalisation treatment with laser or light, radiofrequency, focused ultrasound, chemical peeling, dermabrasion, mesotherapy or any other similar treatment with influence on skin quality in the face within 6 months before study treatment.
Previous aesthetic facial surgical therapy, liposuction or tattoo in the face.
Previous sinus surgery or dental root surgery within 3 months before study treatment.
Active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema, rosacea, acne, psoriasis or herpes zoster in the face.
History of or active collagen diseases or autoimmune diseases such as systemic lupus erythematosus, rheumatic arthritis, skin or systemic sclerosis.
Tendency to form keloids, hypertrophic scars or any other healing disorder.
History of radiation of or cancerous or pre-cancerous lesions (e.g. actinic keratosis) in the face.
Use of systemic or facial topical retinoic acid within 12 months before study treatment.
Nicotine use within 6 months before study treatment. (Occasional smoking, such as 1-5 cigarettes per week, or similar amount of nicotine, is allowed).
Any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. chronic, relapsing or hereditary disease that may interfere with the outcome of the study.
Other condition preventing the subject from entering the study in the Investigator's opinion, e.g. subjects not likely to avoid other facial aesthetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.
Study site personnel or close relatives of the study site personnel (e.g. parents, children, siblings and spouse) or employees at the Sponsor company.
Participation in any other clinical study within 3 months before study treatment.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Rosenpark Research
Darmstadt

Other trials in Germany

About this study

Official title: A Randomised, Multi-centre, Parallel-group, Efficacy and Safety Study Evaluating Two and Three Initial Treatment Sessions of Restylane Skinboosters Vital Lidocaine in the Face

A randomised, multi-centre, parallel-group efficacy and safety study evaluating two and three initial treatment sessions of Restylane Skinboosters Vital Lidocaine in the face.

Read the detailed description

Approximately 50 female subjects shall be treated with two or three initial treatment sessions including long-term follow-up 18 months after the initial treatment regimen. Efficacy and safety to be evaluated.

Conditions: Aged Skin
Being tested: Restylane Vital Skinboosters Lidocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Restylane Vital Skinboosters LidocaineDevice

Study groups in NCT02403986
Study group	Role	What they receive
R. Vital Skinboosters Lidocaine (three)	Experimental	Treatment with three initial sessions Receives: Device: Restylane Vital Skinboosters Lidocaine
R. Vital Skinboosters Lidocaine (two)	Experimental	Treatment with two initial sessions Receives: Device: Restylane Vital Skinboosters Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject
Subject assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS).
GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved.
A clinically significant improvement was defined as a score of improved; much improved; or very much improved.
Measured: Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator
Investigator assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS).
GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved.
A clinically significant improvement was defined as a score of improved; much improved; or very much improved.
Measured: Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201530 Mar 2017

First posted31 Mar 2015 (estimated)
Study startApr 2015
Primary completion30 Mar 2017
Study completion30 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Aged SkinStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02403986
Sponsor's protocol ID: CTN 05DF1404
Status last verified: Sep 2019
First submitted: 26 Mar 2015
Last updated: 26 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Multi-centre, Parallel-group, Efficacy and Safety Study Evaluating Two and Three Initial Treatment Sessions of Restylane Skinboosters Vital Lidocaine in the Face
ClinicalTrials.gov ID: NCT02403986
Acronym / sponsor ID: CTN 05DF1404
Conditions: Aged Skin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Apr 2015
Primary completion: 30 Mar 2017 (actual)
Study completion: 30 Mar 2017 (actual)
First posted: 31 Mar 2015 (estimated)
Results: Posted 6 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A randomised, multi-centre, parallel-group efficacy and safety study evaluating two and three initial treatment sessions of Restylane Skinboosters Vital Lidocaine in the face.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
R. Vital Skinboosters Lidocaine (three)	Experimental	Device: Restylane Vital Skinboosters LidocaineTreatment with three initial sessions
R. Vital Skinboosters Lidocaine (two)	Experimental	Device: Restylane Vital Skinboosters LidocaineTreatment with two initial sessions

Who may qualify

Ages: 35 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Provision of signed and dated informed consent to participate in the study.
Non-pregnant, non-breast feeding female aged 35-45 years.
Visible signs of aging in the face
Intent to improve skin hydration, skin structure and the elasticity of the skin using - Restylane Skinboosters Vital Lidocaine.

Key exclusion criteria (22 listed)

Extensively photo damaged and aged skin.
Woman who plan to become pregnant during the course of the study.
Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel.
Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
History of severe or multiple allergies manifested by anaphylaxis.

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
Restylane Vital Skinboosters Lidocaine	Device	R. Vital Skinboosters Lidocaine (three), R. Vital Skinboosters Lidocaine (two)

Primary outcome

Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months
Subject assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS). GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved. A clinically significant improvement was defined as a score of improved; much improved; or very much improved.
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months
Investigator assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS). GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved. A clinically significant improvement was defined as a score of improved; much improved; or very much improved.

Results and safety

Results posted to the registry on 6 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
R. Vital Skinboosters Lidocaine (Three)	26	21
R. Vital Skinboosters Lidocaine (Two)	27	23

Primary outcome: Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject

Time frame: Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months. Number (95% Confidence Interval). Unit: % improved participants

Measure	R. Vital Skinboosters Lidocaine (Three) n = 24	R. Vital Skinboosters Lidocaine (Two) n = 25
1 month	91.7 (73.0 to 99.0)	80.0 (59.3 to 93.2)
3 months	79.2 (57.8 to 92.9)	72.0 (50.6 to 87.9)
6 months	78.3 (56.3 to 92.5)	58.3 (36.6 to 77.9)
9 months	77.3 (54.6 to 92.2)	50.0 (29.1 to 70.9)
12 months	81.8 (58.1 to 94.6)	60.9 (38.5 to 80.3)
15 months	81.0 (58.1 to 94.6)	68.2 (45.1 to 86.1)
18 months	81.0 (58.1 to 94.6)	77.3 (54.6 to 92.2)

Population analysed: At 1 Month after initial treatment, there were 24 participants in Group A and 25 participants in Group B. (26 and 27 respectively randomized, as reported in Participant Flow.)

Primary outcome: Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator

Time frame: Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months. Number (95% Confidence Interval). Unit: % improved participants

Measure	R. Vital Skinboosters Lidocaine (Three) n = 24	R. Vital Skinboosters Lidocaine (Two) n = 25
1 month	100.0 (85.8 to 100.0)	96.0 (79.6 to 99.9)
3 months	95.8 (78.9 to 99.9)	92.0 (74.0 to 99.0)
6 months	82.6 (61.2 to 95.0)	87.5 (67.6 to 97.3)
9 months	81.8 (59.7 to 94.8)	70.8 (48.9 to 87.4)
12 months	86.4 (65.1 to 97.1)	87.0 (66.4 to 97.2)
15 months	95.2 (76.2 to 99.9)	95.5 (77.2 to 99.9)
18 months	100.0 (83.9 to 100.0)	90.9 (70.8 to 98.9)

Population analysed: At 1 Month after initial treatment, there were 24 participants in Group A and 25 participants in Group B. (26 and 27 respectively randomized, as reported in Participant Flow.)

Adverse events

Time frame: 18 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
R. Vital Skinboosters Lidocaine (Three)	2 of 26 (7.7%)	13 of 26 (50%)	0 of 26
R. Vital Skinboosters Lidocaine (Two)	1 of 27 (3.7%)	10 of 27 (37%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Gerhard Sattler, MD principal investigator

Rosenpark Research

Martina Kerscher, MD principal investigator

University of Hamburg-Eppendorf

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Restylane Vital Skinboosters Lidocaine in people with Aged Skin, run by Galderma R&D at 1 site in Germany.

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 4 inclusion and 22 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 26 Aug 2022. 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 Germany. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject (time frame: Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months). 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?

On the ClinicalTrials.gov record for NCT02403986.

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 26 Aug 2022.