Healthy VolunteersPhase 4NCT03127384
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars
A Phase 4 study testing Restylane Lidocaine in people with Healthy Volunteers, run by Galderma R&D at 2 sites in Germany.
Trial summary
The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Restylane Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesGermany
- Study dates
- 20 Apr 2017to 8 Nov 2018
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Intent to undergo treatment of depressed acne scars
- Presence of 5-20 scars with a diameter of up to approximately 4 mm within the treatment area
- Similar type, size and number of scars on both cheeks
- Men or non-pregnant, non-breast feeding women
- Fitzpatrick skin type I-IV
- Signed and dated informed consent to participate in the study
Who cannot join
- Presence of more than 3 scars per cheek (within the treatment area) of the following types: icepick scars or atrophic acne scars with a diameter of > 4 mm.
- Active acne with inflammatory component
- Use of per oral or topical (facial) substances containing retinoids, bensoyl peroxide, alpha-hydroxy acid at concentrations above 10%, beta-hydroxy acid at a concentration above 2%, or antibiotic treatment for active acne within 4 months before treatment
- Use of isotretinoin within 6 months before treatment
- Post-surgical scars in the treatment area
- Previous tissue augmenting therapy or contouring with permanent filler or fat-injection in the treatment area
Show all 11Show fewer
- Previous tissue augmenting therapy, contouring or revitalisation treatment with Calcium Hydroxyapatite (CaHa), or Poly L-Lactic Acid (PLLA), in the treatment area within 24 months before treatment
- Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler such as hyaluronic acid (HA) or collagen in the treatment area within 12 months before treatment
- Previous tissue revitalisation treatment with neurotoxin, laser or light, mesotherapy, chemical peeling or dermabrasion in the treatment area within 6 months before treatment
- Previous surgery including aesthetic facial surgical therapy, liposuction, or tattoo in the treatment area
- Any medical condition that, in the opinion of the treating Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomised, Evaluator-blind Comparative Study to Evaluate Performance and Safety of Restylane Lidocaine and No-treatment Control for Treatment of Depressed Facial Acne Scars
The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars
- Conditions
- Healthy Volunteers
- Being tested
- Restylane Lidocaine, No-treatment control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane LidocaineDevice
Hyaluronic acid based filler
No-treatment controlOther
No-treatment control
| Study group | Role | What they receive |
|---|---|---|
| No-treatment control | Experimental | Not described Receives: Other: No-treatment control |
| Treatment | Experimental | Intradermal injection Restylane Lidocaine Receives: Device: Restylane Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek
Overall scar severity assessed by blinded evaluator.
Measured: Month 3
Secondary outcomes (1)
Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)
Assessed by blinded evaluator
Measured: Month 1, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start20 Apr 2017
- Primary completion15 Feb 2018
- Study completion8 Nov 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127384
- Sponsor's protocol ID
- 05DF1605
- Status last verified
- Sep 2019
- First submitted
- 20 Apr 2017
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dierickx C, Larsson MK, Blomster S. Effectiveness and Safety of Acne Scar Treatment With Nonanimal Stabilized Hyaluronic Acid Gel. Dermatol Surg. 2018 Nov;44 Suppl 1:S10-S18. doi: 10.1097/DSS.0000000000001689.
PubMed 30358630
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, Evaluator-blind Comparative Study to Evaluate Performance and Safety of Restylane Lidocaine and No-treatment Control for Treatment of Depressed Facial Acne Scars
- ClinicalTrials.gov ID
- NCT03127384
- Acronym / sponsor ID
- 05DF1605
- Conditions
- Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Posted 3 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-treatment control | Experimental | Other: No-treatment control |
| Treatment | Experimental | Device: Restylane LidocaineIntradermal injection Restylane Lidocaine |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Intent to undergo treatment of depressed acne scars
- Presence of 5-20 scars with a diameter of up to approximately 4 mm within the treatment area
- Similar type, size and number of scars on both cheeks
- Men or non-pregnant, non-breast feeding women
- Fitzpatrick skin type I-IV
Key exclusion criteria (11 listed)
- Presence of more than 3 scars per cheek (within the treatment area) of the following types: icepick scars or atrophic acne scars with a diameter of > 4 mm.
- Active acne with inflammatory component
- Use of per oral or topical (facial) substances containing retinoids, bensoyl peroxide, alpha-hydroxy acid at concentrations above 10%, beta-hydroxy acid at a concentration above 2%, or antibiotic treatment for active acne within 4 months before treatment
- Use of isotretinoin within 6 months before treatment
- Post-surgical scars in the treatment area
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 LidocaineHyaluronic acid based filler | Device | Treatment |
| No-treatment controlNo-treatment control | Other | No-treatment control |
Primary outcome
Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek
Time frame: Month 3
Overall scar severity assessed by blinded evaluator.
1 secondary outcome
Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)
Time frame: Month 1, Month 3
Results and safety
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.
- Results publication: PubMed 30358630Dierickx C, Larsson MK, Blomster S. Effectiveness and Safety of Acne Scar Treatment With Nonanimal Stabilized Hyaluronic Acid Gel. Dermatol Surg. 2018 Nov;44 Suppl 1:S10-S18. doi: 10.1097/DSS.0000000000001689.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Study Director study director
Galderma R&D
2 sites 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 Lidocaine in people with Healthy Volunteers, run by Galderma R&D at 2 sites 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 6 inclusion and 11 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 2 sites 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 3 Oct 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 Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek (time frame: Month 3). 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 NCT03127384, which also lists 1 linked publication.
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.