Acne ScarsPhase 4NCT01807455
An Open, Non-comparative Study of the Efficacy and Safety of Treatment of Acne Scars With Restylane Vital Lidocaine
A Phase 4 study testing Restylane Vital Lidocaine in people with Acne Scars, run by Galderma R&D at 1 site in Belgium.
Trial summary
The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital Lidocaine when acne scars are treated Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Acne Scars
- What is being tested?
- Restylane Vital Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2013to Dec 2014
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female aged 25 to 45 years.
- Caucasian with Fitzpatrick skin type I-III.
- Must be cooperative and willing to comply with the instructions and procedures.
- Provision of signed and dated informed consent to participate in the study.
- Presence of depressed facial atrophic acne scars with a diameter of <4 mm according to at least SCAR-S score 3 category moderate (i.e. more than half of the face involved).
Who cannot join
- Icepick scarring or atrophic scars with a diameter of ≥4 mm covering more than 25% of the face.
- Active acne with inflammatory component.
- Post-surgical scars in the face.
- History of keloid formation or hypertrophic scars.
- Use of isotretinoin within 12 months of the baseline visit.
- Use of per oral or topical (facial) substances containing retinoids, bensoyl peroxide, alpha-hydroxy acid at a concentration above 10% or beta-hydroxy acid at a concentration above 2% or antibiotics within four months of the baseline visit.
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- Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs [NSAIDs]), Omega-3 or vitamin E seven days before the injection, or a history of bleeding disorders.
- Use of anti-inflammatory agents seven days before the injection.
- History of radiation or skin tumours including actinic keratosis in the face.
- Active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema and rosacea in the face.
- History of or active collagen diseases or autoimmune diseases such as systemic lupus erythematous, rheumatic arthritis, skin or systemic sclerosis.
- Previous hypersensitivity to HA.
- Previous hypersensitivity to lidocaine or other amide-type anaesthetics.
- Concomitant treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids within 3 months of the baseline visit. (Inhaled corticoids are not an exclusion criterion).
- Presence of facial hair that may interfere with efficacy evaluations.
- Previous tissue augmenting therapy or revitalization treatment in the treatment area with HA or collagen, within 12 months of the baseline visit.
- Permanent implant or treatment with fillers based on other material than HA or collagen in the treatment area.
- Laser, e.g. carbon dioxide and Fraxel, dermabrasion or facial light therapy, e.g. IPL, in the treatment area within 12 months of the baseline visit.
- Chemical peeling in the treatment area within 6 months of the baseline visit.
- Previous surgery in the treatment area.
- Nicotine use within 6 months before the baseline visit.
- Pregnancy or breast feeding.
- Participation in any other clinical study within 30 days before inclusion.
- Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion (e.g. severe chronic disease, epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction).
- Other condition preventing the subject from entering the study in the investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable or incapable of understanding the study assessment or unrealistic expectations of treatment result.
- Study staff or close relative of study staff (e.g. parents, children, siblings and spouse).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital Lidocaine when acne scars are treated
- Conditions
- Acne Scars
- Being tested
- Restylane Vital Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane Vital LidocaineDevice
| Study group | Role | What they receive |
|---|---|---|
| Restylane Vital Lidocaine | Experimental | Not described Receives: Device: Restylane Vital Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale
Percentage of improved subjects at 36 weeks after first treatment session assessed using Subject GAIS. Scale range is Worse, No Change, Somewhat Improved, Much Improved and Very Much Improved. Alternatives Somewhat Improved to Very Much Improved are considered an improvement, i.e. a better outcome.
Measured: 36 weeks
Secondary outcomes (4)
Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire
Percentage of subjects satisfied with the overall appearance of the face at 36 weeks after first treatment session. Scale range is Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied and Very satisfied. Alternatives Somewhat satisfied to Very satified are considered a better outcome.
Measured: 36 weeks
Evaluation of Acne Scarring Using the Scale for Acne Scar Severity (SCAR-S)
Percentage of subjects improved at 36 weeks after first treatment session assessed using SCAR-S. Scale range is Very severe, Severe, Moderate, Mild, Almost clear and Clear. The alternative Clear is considered the best outcome. Improvement is considered to be at least one step improvement on the scale toward the alternative Clear.
Measured: 36 weeks
Assessment of Local Tolerability After Treatment
Number of subjects reporting anticipated injection-related reactions after treatment
Measured: 14 days
Adverse Event Reporting During the Study
Number of subjects reporting at least one adverse event (assessed as unrelated or related to treatment)
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionDec 2014
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 Acne ScarsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Dierickx, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807455
- Sponsor's protocol ID
- 05DF1206
- Status last verified
- Dec 2015
- First submitted
- 6 Mar 2013
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- An Open, Non-comparative Study of the Efficacy and Safety of Treatment of Acne Scars With Restylane Vital Lidocaine
- ClinicalTrials.gov ID
- NCT01807455
- Acronym / sponsor ID
- 05DF1206
- Conditions
- Acne Scars
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Posted 25 Jan 2016
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 demonstrate the efficacy and safety of Restylane Vital Lidocaine when acne scars are treated
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restylane Vital Lidocaine | Experimental | Device: Restylane Vital Lidocaine |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female aged 25 to 45 years.
- Caucasian with Fitzpatrick skin type I-III.
- Must be cooperative and willing to comply with the instructions and procedures.
- Provision of signed and dated informed consent to participate in the study.
- Presence of depressed facial atrophic acne scars with a diameter of <4 mm according to at least SCAR-S score 3 category moderate (i.e. more than half of the face involved).
Key exclusion criteria (26 listed)
- Icepick scarring or atrophic scars with a diameter of ≥4 mm covering more than 25% of the face.
- Active acne with inflammatory component.
- Post-surgical scars in the face.
- History of keloid formation or hypertrophic scars.
- Use of isotretinoin within 12 months of the baseline visit.
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 Lidocaine | Device | Restylane Vital Lidocaine |
Primary outcome
Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale
Time frame: 36 weeks
Percentage of improved subjects at 36 weeks after first treatment session assessed using Subject GAIS. Scale range is Worse, No Change, Somewhat Improved, Much Improved and Very Much Improved. Alternatives Somewhat Improved to Very Much Improved are considered an improvement, i.e. a better outcome.
4 secondary outcomes
Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire
Time frame: 36 weeks
Evaluation of Acne Scarring Using the Scale for Acne Scar Severity (SCAR-S)
Time frame: 36 weeks
Assessment of Local Tolerability After Treatment
Time frame: 14 days
Adverse Event Reporting During the Study
Time frame: 36 weeks
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.
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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.
Christine Dierickx, MD principal investigator
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 Lidocaine in people with Acne Scars, run by Galderma R&D at 1 site in Belgium.
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 5 inclusion and 26 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 Belgium. 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 25 Jan 2016). 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?
Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale (time frame: 36 weeks). 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 26 Aug 2022.