Atrophic Acne ScarsNCT02643628

A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne Scars

A study testing Microneedling and Microneedling followed by Bellafill treatment in people with Atrophic Acne Scars, run by Suneva Medical, Inc. at 1 site in United States.

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

This is an open-label, randomized, multicenter, prospective trial assessing the efficacy and safety of microneedling treatment alone vs. microneedling treatment followed by treatment with Bellafill for correction of distensible atrophic facial acne scars. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Atrophic Acne Scars
What is being tested?: Microneedling and Microneedling followed by Bellafill treatment
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited States
Study dates: 10 Oct 2015to 5 Jun 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 located within the facial treatment area. Subject desires correction of his/her atrophic acne scarring.
All Fitzpatrick skin types are eligible.
Subjects with a history of HSV-1 (oral herpetic outbreak) willing to accept prophylactic treatment with antiviral medication.
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 5.3) 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.
Excisional facial surgery (such as Blepharoplasty, Face Lift, Rhinoplasty) of the face ≤ 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.

United States1 site

Call Suneva for Info
Nashville, Tennessee, 37203

Other trials in United States

About this study

Read the detailed description

The study is divided into two study Periods. In Period I, subjects will attend a Screening visit (Week -4) and undergo the Bellafill skin test. At Visit 1 (Day 0), all subjects will commence microneedling treatment for their atrophic acne scars. Subjects will then return to the clinic at Week 3 and Week 6 (Visits 2 and 3, respectively) for follow-up evaluation and additional cycles of microneedling treatment.

At Week 12 (Visit 4), all subjects commence Period II and are randomized to Bellafill Treatment (Track A) or to No Treatment (Track B):

Track A: Consists of three (3) study visits. At Visit 4, subjects randomized to the "Bellafill" group will receive treatment with Bellafill for their atrophic acne scars. Subjects return for Visit 5A (Month 1 after randomization) for evaluation and follow-up, and will receive touch-up injections with Bellafill to achieve optimal correction (if necessary). Subjects will then be followed-up at Visits 6A and 7A which will occur at Month 3 and Month 6, respectively, after their last Bellafill treatment.
Track B: Consists of one (1) study visit. At Visit 4, subjects randomized to the "No Treatment" group will complete visit evaluations and then return for follow-up at Visit 5B (approx. Month 3 after randomization).

Conditions: Atrophic Acne Scars
Being tested: Microneedling, Microneedling followed by Bellafill treatment

What participants receive

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

MicroneedlingProcedure or surgery
Microneedling followed by Bellafill treatmentDevice

Study groups in NCT02643628
Study group	Role	What they receive
Microneedling Only	Experimental	All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction. Receives: Procedure: Microneedling
Microneedling followed by Bellafill treatment	Experimental	Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction. Receives: Device: Microneedling followed by Bellafill treatment

What is being measured

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

Acne Scar Assessment Scale (ASAS)
- Acne Scar Assessment Scale (ASAS): a validated 5-point static scale assessing physician impression of acne scar severity where as 1=clear and 5 = severe
Measured: 6 months post-injection for Bellafill arm. 3 months Microneedling alone arm
Physician Global Aesthetic Improvement Scale (PGAIS)
The PGAIS is used for the physician to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse
Measured: From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm
Subject Global Aesthetic Improvement Scale (SGAIS)
The SGAIS is used for the subject to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse
Measured: From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm
Quality of Life Impact Scar (QOLIS)
Quality of Life Scar Impact Scale questionnaire was used to allow the subject to specifically address how acne scarring has affected his/her emotional and functional status. Subjects completed 33 questions ratings between 1 and 7 one being less severe 4 neutral and 7 more severe. Scores are averaged for a total range of 1-7.
Measured: 6-months for the Treatment arm and 3 months for the Microneedling only arm
Number of Subjects With Adverse Events
Measured: 6-months

Timeline

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

10 Oct 20155 Jun 2017

First posted31 Dec 2015 (estimated)
Study start10 Oct 2015
Primary completion5 Jun 2017
Study completion5 Jun 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 Atrophic Acne ScarsStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02643628
Sponsor's protocol ID: SUN-1503
Status last verified: Sep 2019
First submitted: 29 Dec 2015
Last updated: 28 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne Scars
ClinicalTrials.gov ID: NCT02643628
Acronym / sponsor ID: SUN-1503
Conditions: Atrophic Acne Scars
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Suneva Medical, Inc.Industry (pharma, biotech, devices)
Collaborators: ethica Clinical Research Inc.
Study start: 10 Oct 2015 (actual)
Primary completion: 5 Jun 2017 (actual)
Study completion: 5 Jun 2017 (actual)
First posted: 31 Dec 2015 (estimated)
Results: Posted 28 Oct 2019

Clinical summary

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

Detailed description

At Week 12 (Visit 4), all subjects commence Period II and are randomized to Bellafill Treatment (Track A) or to No Treatment (Track B):

Track A: Consists of three (3) study visits. At Visit 4, subjects randomized to the "Bellafill" group will receive treatment with Bellafill for their atrophic acne scars. Subjects return for Visit 5A (Month 1 after randomization) for evaluation and follow-up, and will receive touch-up injections with Bellafill to achieve optimal correction (if necessary). Subjects will then be followed-up at Visits 6A and 7A which will occur at Month 3 and Month 6, respectively, after their last Bellafill treatment.
Track B: Consists of one (1) study visit. At Visit 4, subjects randomized to the "No Treatment" group will complete visit evaluations and then return for follow-up at Visit 5B (approx. Month 3 after randomization).

Study design

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

Arm	Type	Receives
Microneedling Only	Experimental	Procedure: MicroneedlingAll eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction.
Microneedling followed by Bellafill treatment	Experimental	Device: Microneedling followed by Bellafill treatmentSubjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, 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 located within the facial treatment area. Subject desires correction of his/her atrophic acne scarring.
All Fitzpatrick skin types are eligible.
Subjects with a history of HSV-1 (oral herpetic outbreak) willing to accept prophylactic treatment with antiviral medication.

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.
Excisional facial surgery (such as Blepharoplasty, Face Lift, Rhinoplasty) of the face ≤ 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
Microneedling	Procedure or surgery	Microneedling Only
Microneedling followed by Bellafill treatment	Device	Microneedling followed by Bellafill treatment

Primary outcome

Acne Scar Assessment Scale (ASAS)
Time frame: 6 months post-injection for Bellafill arm. 3 months Microneedling alone arm
• Acne Scar Assessment Scale (ASAS): a validated 5-point static scale assessing physician impression of acne scar severity where as 1=clear and 5 = severe
Physician Global Aesthetic Improvement Scale (PGAIS)
Time frame: From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm
The PGAIS is used for the physician to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse
Subject Global Aesthetic Improvement Scale (SGAIS)
Time frame: From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm
The SGAIS is used for the subject to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse
Quality of Life Impact Scar (QOLIS)
Time frame: 6-months for the Treatment arm and 3 months for the Microneedling only arm
Quality of Life Scar Impact Scale questionnaire was used to allow the subject to specifically address how acne scarring has affected his/her emotional and functional status. Subjects completed 33 questions ratings between 1 and 7 one being less severe 4 neutral and 7 more severe. Scores are averaged for a total range of 1-7.
Number of Subjects With Adverse Events
Time frame: 6-months

Results and safety

Results posted to the registry on 28 Oct 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
Microneedling Only	21	20
Microneedling Followed by Bellafill Treatment	23	17

Primary outcome: Acne Scar Assessment Scale (ASAS)

Time frame: 6 months post-injection for Bellafill arm. 3 months Microneedling alone arm. Mean (Standard Deviation). Unit: units on a scale

Measure	Microneedling Followed by Bellafill Treatment n = 17	Microneedling Only n = 19
Value	2.65 (0.75)	3.71 (0.75)

Population analysed: All subjects

Primary outcome: Physician Global Aesthetic Improvement Scale (PGAIS)

Time frame: From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm. Mean (Standard Deviation). Unit: units on a scale

Measure	Microneedling Only n = 19	Microneedling Followed by Bellafill Treatment n = 17
Value	0.05 (0.62)	0.35 (0.49)

Population analysed: There were 21 subjects in the microneedling arm however data only available for 19 subjects

Primary outcome: Subject Global Aesthetic Improvement Scale (SGAIS)

Time frame: From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm. Mean (Standard Deviation). Unit: units on a scale

Measure	Microneedling Only n = 19	Microneedling Followed by Bellafill Treatment n = 17
Value	0.05 (0.62)	0.18 (0.39)

Population analysed: There were 21 subjects in the microneedling arm however data only available for 19 subjects

Primary outcome: Quality of Life Impact Scar (QOLIS)

Time frame: 6-months for the Treatment arm and 3 months for the Microneedling only arm. Mean (Standard Deviation). Unit: units on a scale

Measure	Microneedling Only n = 20	Microneedling Followed by Bellafill Treatment n = 17
Value	3.90 (1.45)	2.47 (1.42)

Adverse events

Time frame: six (6) months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Microneedling Followed by Bellafill Treatment	0 of 23 (0%)	2 of 23 (8.7%)	0 of 23
Microneedling Only	0 of 21 (0%)	1 of 21 (4.8%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Microneedling and Microneedling followed by Bellafill treatment in people with Atrophic Acne Scars, 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 28 Oct 2019. 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 28 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?

Acne Scar Assessment Scale (ASAS) (time frame: 6 months post-injection for Bellafill arm. 3 months Microneedling alone arm). The study lists 5 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 NCT02643628.

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 28 Oct 2019.