Atrophic Acne ScarringNCT02642627
The Use of Bellafill for Atrophic Acne Scar Correction in the Full Facial Area
A study testing Bellafill in people with Atrophic Acne Scarring, run by Suneva Medical, Inc. at 1 site in United States.
Trial summary
This is an open-label, multicenter, prospective pilot study assessing the efficacy and safety of Bellafill for correction of distensible atrophic acne scars in the full facial area. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrophic Acne Scarring
- What is being tested?
- Bellafill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2015to 27 Jan 2017
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient, male or female subjects of any race, 21 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study.
- Negative response to the Bellafill Skin Test.
- Presence of ≥4 distensible atrophic acne scars (treatment scars) in in the facial area.
- Subject desires correction of his/her atrophic acne scarring.
- All Fitzpatrick skin types are eligible.
- Willing to withhold additional aesthetic therapies to the proposed treatment area (e.g., other soft tissue fillers such as hyaluronic acid, and/or any resurfacing procedures (as described in Protocol Section 5.4) for the duration of the study.
- Able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
- Sign an IRB-approved Informed Consent Form, Photographic Release Form, and the Authorization for Use and release of Health and Research Study Information (HIPAA) Form prior to any study-related procedures being performed.
Who cannot join
- Female subjects that are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- Undergone facial treatments with any prohibited treatment/procedures and/or use of any other prohibited treatment/procedure within certain time periods as listed in Protocol Section 5.4.
- Excisional facial surgery (such as Blepharoplasty, Face Lift, Rhinoplasty) of the face less than 6 months prior to study enrollment or plans for facial surgery during the study.
- History of bleeding disorders.
- Presence of any skin pathology or condition that could interfere with the evaluation of the treatment areas, worsen due to the proposed treatment or require interfering topical, systemic or surgical therapy.
- Recent or current history of inflammatory skin disease, infection, cancerous/pre-cancerous lesion, unhealed wound or clinically significant acne in the proposed treatment areas. Clinically significant acne is defined as a patient whom has ≥3 active inflammatory acne lesions in the treatment areas.
Show all 16Show fewer
- History of systemic granulomatous diseases active or inactive (e.g., Sarcoid, Wegeners, TB) or connective tissue diseases (e.g., lupus, dermatomyositis).
- Hypertrophic acne scars, any evidence of keloid scarring in the treatment area.
- Known hypersensitivity or previous allergic reaction to any of the components of the study device (including lidocaine or any amide-based anesthetic), or has a history of allergies to any bovine collagen products, including but not limited to injectable collagen, collagen implants, hemostatic sponges, and collagen-based sutures.
- Undergone or be planning to undergo desensitization injections to meat products.
- Unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking), poor mental development, or impaired cerebral function.
- Evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-compliance with medical treatment, or unreliability.
- Use of an investigational device, biologic or drug in the past 30 days, or be currently participating in an experimental drug, biologic or device trial.
- Exhibits additional physical attributes which prevent the assessment or treatment of the atrophic scars, as judged by the Investigator, such as excessive hair, traumatic or surgical scars, excessive hyperpigmentation in the treatment area, etc.
- Has a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
- An employee (or a relative of an employee) of the Investigator, Sponsor or representative of the Sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label, multicenter, prospective pilot study assessing the efficacy and safety of Bellafill for correction of distensible atrophic acne scars in the full facial area. All enrolled subjects will receive initial treatment with Bellafill, as well as touch-up treatments (if necessary to achieve optimal correction). Subjects will be evaluated at Screening (Month -1), Day 0 (Baseline) Month 1, Month 4, and Month 7.
Read the detailed description
Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated.
Bellafill should be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired
level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.
Treatment Area
There will be four "quadrants" of the face where treatment is allowed and grading will occur. The glabellar, nose and upper lip areas are not to be treated:
- The glabellar "no treatment" zone is defined as the area between the mid-pupillary lines up to 2 cm above the highest point of the eyebrow. This area will not receive treatment;
- The no treatment area of the nose extends from the nasal bridge (and is contiguous with the glabellar no treatment zone) to the nasal sill and laterally to the cheek;
- The upper lip will be defined as the area from the vermillion border of the upper lip to the nasal sill superiorly and the nasolabial fold laterally;
- The face is split at the midline of the forehead and the chin and where the nose meets the cheek, creating two halves. Each half is then divided into upper and lower quadrants by a line extending from the lateral canthus to the superior junction of the pinna and the cheek.
Each quadrant will be graded individually and receive a separate grade. The no treatment zones of the glabella, nose and upper lip should be respected as they have been selected to maximize the safety of the subject. A "touch-up treatment" is permitted at study Visit 3 (Month 1). The Investigator will evaluate each lesion and determine if a treated scar is undercorrected and whether additional improvement could be obtained with a touch-up treatment.
- Conditions
- Atrophic Acne Scarring
- Being tested
- Bellafill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BellafillDevice
| Study group | Role | What they receive |
|---|---|---|
| Bellafill Injections | Experimental | Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction. Receives: Device: Bellafill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the Acne Scar Assessment Scale (ASAS)
A validated 5-point static scale assessing physician impression of acne scar severity. The total range on the scale is 1-5 (1= Clear and 5 = Severe) Clear: No depressions are seen in the treatment area. Macular discoloration may be seen.
Very Mild: A single depression is easily noticeable with direct lighting (deep). Most or all of the depressions seen are only readily apparent with tangential lighting (shallow).
Mild: A few to several, but less than half of all the depressions are easily noticeable with direct lighting (deep). Most of the depressions seen are only readily apparent with tangential lighting (shallow).
Moderate: More than half of the depressions are apparent with direct lighting (deep).
Severe: All or almost all the lesions can be seen with direct lighting (deep)
Measured: Month 1, 4 and 7
Secondary outcomes (1)
Adverse Events
Throughout the course of the study, all AEs will be monitored and reported through the CRF. All AEs occurring after study device administration were followed until the event has resolved or stabilized or until follow-up was no longer possible.
Measured: month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study start18 Nov 2015
- Primary completion27 Jan 2017
- Study completion27 Jan 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrophic Acne ScarringStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suneva Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Responsible party
- Sponsor
- Investigators
- Nancy Seretta, Study director, Suneva Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642627
- Sponsor's protocol ID
- SUN-1504
- Status last verified
- Sep 2019
- First submitted
- 28 Dec 2015
- Last updated
- 6 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Joseph JH, Shamban A, Eaton L, Lehman A, Cohen S, Spencer J, Bruce S, Grimes P, Tedaldi R, Callender V, Werschler P. Polymethylmethacrylate Collagen Gel-Injectable Dermal Filler for Full Face Atrophic Acne Scar Correction. Dermatol Surg. 2019 Dec;45(12):1558-1566. doi: 10.1097/DSS.0000000000001863.
PubMed 30829754
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Bellafill for Atrophic Acne Scar Correction in the Full Facial Area
- ClinicalTrials.gov ID
- NCT02642627
- Acronym / sponsor ID
- SUN-1504
- Conditions
- Atrophic Acne Scarring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Suneva Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Study start
- 18 Nov 2015 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 27 Jan 2017 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Posted 6 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, prospective pilot study assessing the efficacy and safety of Bellafill for correction of distensible atrophic acne scars in the full facial area. All enrolled subjects will receive initial treatment with Bellafill, as well as touch-up treatments (if necessary to achieve optimal correction). Subjects will be evaluated at Screening (Month -1), Day 0 (Baseline) Month 1, Month 4, and Month 7.
Detailed description
Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated.
Bellafill should be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired
level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.
Treatment Area
There will be four "quadrants" of the face where treatment is allowed and grading will occur. The glabellar, nose and upper lip areas are not to be treated:
- The glabellar "no treatment" zone is defined as the area between the mid-pupillary lines up to 2 cm above the highest point of the eyebrow. This area will not receive treatment;
- The no treatment area of the nose extends from the nasal bridge (and is contiguous with the glabellar no treatment zone) to the nasal sill and laterally to the cheek;
- The upper lip will be defined as the area from the vermillion border of the upper lip to the nasal sill superiorly and the nasolabial fold laterally;
- The face is split at the midline of the forehead and the chin and where the nose meets the cheek, creating two halves. Each half is then divided into upper and lower quadrants by a line extending from the lateral canthus to the superior junction of the pinna and the cheek.
Each quadrant will be graded individually and receive a separate grade. The no treatment zones of the glabella, nose and upper lip should be respected as they have been selected to maximize the safety of the subject. A "touch-up treatment" is permitted at study Visit 3 (Month 1). The Investigator will evaluate each lesion and determine if a treated scar is undercorrected and whether additional improvement could be obtained with a touch-up treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bellafill Injections | Experimental | Device: BellafillCorrectable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Outpatient, male or female subjects of any race, 21 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study.
- Negative response to the Bellafill Skin Test.
- Presence of ≥4 distensible atrophic acne scars (treatment scars) in in the facial area.
- Subject desires correction of his/her atrophic acne scarring.
- All Fitzpatrick skin types are eligible.
Key exclusion criteria (16 listed)
- Female subjects that are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- Undergone facial treatments with any prohibited treatment/procedures and/or use of any other prohibited treatment/procedure within certain time periods as listed in Protocol Section 5.4.
- Excisional facial surgery (such as Blepharoplasty, Face Lift, Rhinoplasty) of the face less than 6 months prior to study enrollment or plans for facial surgery during the study.
- History of bleeding disorders.
- Presence of any skin pathology or condition that could interfere with the evaluation of the treatment areas, worsen due to the proposed treatment or require interfering topical, systemic or surgical 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 |
|---|---|---|
| Bellafill | Device | Bellafill Injections |
Primary outcome
Change on the Acne Scar Assessment Scale (ASAS)
Time frame: Month 1, 4 and 7
A validated 5-point static scale assessing physician impression of acne scar severity. The total range on the scale is 1-5 (1= Clear and 5 = Severe) Clear: No depressions are seen in the treatment area. Macular discoloration may be seen. Very Mild: A single depression is easily noticeable with direct lighting (deep). Most or all of the depressions seen are only readily apparent with tangential lighting (shallow). Mild: A few to several, but less than half of all the depressions are easily noticeable with direct lighting (deep). Most of the depressions seen are only readily apparent with tangential lighting (shallow). Moderate: More than half of the depressions are apparent with direct lighting (deep). Severe: All or almost all the lesions can be seen with direct lighting (deep)
1 secondary outcome
Adverse Events
Time frame: month 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30829754Joseph JH, Shamban A, Eaton L, Lehman A, Cohen S, Spencer J, Bruce S, Grimes P, Tedaldi R, Callender V, Werschler P. Polymethylmethacrylate Collagen Gel-Injectable Dermal Filler for Full Face Atrophic Acne Scar Correction. Dermatol Surg. 2019 Dec;45(12):1558-1566. doi: 10.1097/DSS.0000000000001863.
- Individual participant dataSharing planned: No
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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.
Nancy Seretta study director
Suneva Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bellafill in people with Atrophic Acne Scarring, run by Suneva Medical, Inc. at 1 site in United States.
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 8 inclusion and 16 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 6 Apr 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2020). 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?
Change on the Acne Scar Assessment Scale (ASAS) (time frame: Month 1, 4 and 7). 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 NCT02642627, 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 6 Apr 2020.