Acne ScarsNCT03901417
Comparison of 1550nm Fractional Laser Alone Versus in Combination With Microneedling for the Treatment of Acne Scars
A study testing Fraxel Restore (Non-ablative Fractional Laser) and Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device) in people with Acne Scars, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Acne scarring is an unfortunate consequence of inflammatory acne vulgaris that often leads to significant cosmetic and psychosocial impacts. Although there have been many advances in the treatment of acne scarring, it remains one of the greatest challenges in cosmetic and laser dermatology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Scars
- What is being tested?
- Fraxel Restore (Non-ablative Fractional Laser) and Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All gender patients
- Age older than 18 years
- Fitzpatrick skin types I-III
- Facial acne scarring of grades III-IV
- Both sides of the face should have similar amount and severity of acne scarring
Who cannot join
- History of keloidal scarring
- Localized or active infection in the treatment region
- Immunodeficiency disorders
- Porphyria or light sensitivity
- Connective tissue disorders.
- Pregnant or nursing
Show all 9Show fewer
- Recent isotretinoin use within the past 6 months
- Renal Disease
- Allergies to lidocaine, tetracaine, valacyclovir
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Randomized, Double-blind, Split-face Controlled Pilot Study to Assess the Efficacy of Combination Microneedling and Non-ablative Fractional Laser Versus Non-ablative Fractional Laser Alone for Treatment of Atrophic Acne Scars
Acne scarring is an unfortunate consequence of inflammatory acne vulgaris that often leads to significant cosmetic and psychosocial impacts. Although there have been many advances in the treatment of acne scarring, it remains one of the greatest challenges in cosmetic and laser dermatology.
There have been a multitude of studies establishing the efficacy of non-ablative fractional laser therapy for the treatment of atrophic acne scars, and it is widely regarded as one of the best available treatments. More recently, there has been a renewed interest in controlled, non-thermal dermal injury via microneedling devices in the treatment of atrophic acne scars.
Read more
Where there is a gap in the literature, however, is in the evaluation of the combination of non-ablative fractional laser resurfacing with microneedling in the treatment of atrophic acne scars.
The investigators' study will compare the safety and efficacy of using non-ablative fractional laser versus a combination of microneedling and non-ablative fractional laser for atrophic acne scars using a randomized, double-blind, split-face study.
The investigators' aim is to further elucidate the pathogenesis of acne scarring and the best approaches for treatment. In doing so, the investigators will study a combination approach to this complex problem in order to better serve future patients.
Read the detailed description
Acne vulgaris is a highly prevalent dermatologic disorder that affects up to 90% percent of the population at some point in their lives to varying degrees. Acne scarring is an unfortunate complication of the inflammation that results if acne is not sufficiently treated. Classically, acne scarring has been described as either atrophic, hypertrophic, keloidal, or pigmented. Atrophic is by far the most common type of acne scarring and is subdivided into boxcar, rolling, and icepick subtypes. The presence of acne scarring has been associated with a significant decrease in patient well-being and has many psychosocial implications. Although the understanding of the pathogenesis, prevention, and treatment of acne scarring has come a long way, there are limitations to the current treatment options and the search for a cure continues.
One of the greatest advances in the treatment of acne scarring came with the advent of non-ablative fractional lasers, which work through the theory of fractional photothermolysis. Fractional photothermolysis relies on the principle of creating thousands of microthermal injury zones in the skin while allowing the surrounding intact skin to expedite wound healing. The relative sparing of the epidermis while facilitating collagen remodeling in the dermis underlies the use of non-ablative fractional laser therapy in the treatment of atrophic scars.
The erbium-doped 1,550-nm non-ablative fractional laser has been extensively studied in the treatment of atrophic acne scars with good efficacy and safety.
The concept of using needle subcision for the treatment of depressed surgical scars was first described by Orentreich et al in 1995. The first microneedling device, a drum-shaped roller was subsequently developed by Fernandes et al in the early 2000s. Several studies have validated the use of microneedling for acne scarring with a similar mechanism of creating microchannels in the dermis that allow for collagen remodeling. Furthermore, microneedling has been demonstrated to induce a specific cytokine profile including fibroblast-like growth factor, vascular endothelial growth factor, epidermal growth factor, and transforming growth factor-beta3 which are associated with favorable wound healing.
More recently, experts have advocated for the use of electric-powered microneedling devices which allow for more controlled injury at a set depth, density, and speed for the treatment of atrophic acne scars with good results.
To the investigators' knowledge, this study will be the first of its kind to compare the efficacy and safety of a combination of 1,550-nm erbium-doped fractional laser and microneedling with the SkinPenTM device to 1,550-nm erbium-doped fractional laser alone in the treatment of atrophic acne scars.
Both treatment modalities in this study are already FDA approved treatment modalities for acne scarring.
- Conditions
- Acne Scars
- Being tested
- Fraxel Restore (Non-ablative Fractional Laser), Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fraxel Restore (Non-ablative Fractional Laser)Device
In the study, one side of the face will be treated with non-ablative fractional laser monthly for three months.
Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device)Device
In the study, one side of the face will be treated with a combination of non-ablative fractional laser and microneedling monthly for three months.
| Study group | Role | What they receive |
|---|---|---|
| Non-ablative Fractional Laser | Active comparator | Non-ablative fractional laser (brand name Fraxel Restore) only on one half of the face. Receives: Device: Fraxel Restore (Non-ablative Fractional Laser) |
| Non-ablative Fractional Laser Plus Microneedling | Active comparator | Non-ablative fractional laser (brand name Fraxel Restore) in combination with a microneedling device (SkinPen) on the other half of the face. Receives: Device: Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in acne scarring
Two blinded evaluators will use standardized digital photographic review to grade acne scar improvement on a quartile grading scale (1 = 1% to 25%, 2 = 26 to 50%, 3 = 51 to 75%, 4 = >76% improvement).
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Jun 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized split-face clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathew Avram, MD, JD, Massachusetts General Hospital
- Investigators
- Mathew Avram, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901417
- Sponsor's protocol ID
- 2018P002595
- Status last verified
- Jan 2020
- First submitted
- 26 Mar 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Split-face Controlled Pilot Study to Assess the Efficacy of Combination Microneedling and Non-ablative Fractional Laser Versus Non-ablative Fractional Laser Alone for Treatment of Atrophic Acne Scars
- ClinicalTrials.gov ID
- NCT03901417
- Acronym / sponsor ID
- 2018P002595
- Conditions
- Acne Scars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acne scarring is an unfortunate consequence of inflammatory acne vulgaris that often leads to significant cosmetic and psychosocial impacts. Although there have been many advances in the treatment of acne scarring, it remains one of the greatest challenges in cosmetic and laser dermatology.
There have been a multitude of studies establishing the efficacy of non-ablative fractional laser therapy for the treatment of atrophic acne scars, and it is widely regarded as one of the best available treatments. More recently, there has been a renewed interest in controlled, non-thermal dermal injury via microneedling devices in the treatment of atrophic acne scars.
Where there is a gap in the literature, however, is in the evaluation of the combination of non-ablative fractional laser resurfacing with microneedling in the treatment of atrophic acne scars.
The investigators' study will compare the safety and efficacy of using non-ablative fractional laser versus a combination of microneedling and non-ablative fractional laser for atrophic acne scars using a randomized, double-blind, split-face study.
The investigators' aim is to further elucidate the pathogenesis of acne scarring and the best approaches for treatment. In doing so, the investigators will study a combination approach to this complex problem in order to better serve future patients.
Detailed description
Acne vulgaris is a highly prevalent dermatologic disorder that affects up to 90% percent of the population at some point in their lives to varying degrees. Acne scarring is an unfortunate complication of the inflammation that results if acne is not sufficiently treated. Classically, acne scarring has been described as either atrophic, hypertrophic, keloidal, or pigmented. Atrophic is by far the most common type of acne scarring and is subdivided into boxcar, rolling, and icepick subtypes. The presence of acne scarring has been associated with a significant decrease in patient well-being and has many psychosocial implications. Although the understanding of the pathogenesis, prevention, and treatment of acne scarring has come a long way, there are limitations to the current treatment options and the search for a cure continues.
One of the greatest advances in the treatment of acne scarring came with the advent of non-ablative fractional lasers, which work through the theory of fractional photothermolysis. Fractional photothermolysis relies on the principle of creating thousands of microthermal injury zones in the skin while allowing the surrounding intact skin to expedite wound healing. The relative sparing of the epidermis while facilitating collagen remodeling in the dermis underlies the use of non-ablative fractional laser therapy in the treatment of atrophic scars.
The erbium-doped 1,550-nm non-ablative fractional laser has been extensively studied in the treatment of atrophic acne scars with good efficacy and safety.
The concept of using needle subcision for the treatment of depressed surgical scars was first described by Orentreich et al in 1995. The first microneedling device, a drum-shaped roller was subsequently developed by Fernandes et al in the early 2000s. Several studies have validated the use of microneedling for acne scarring with a similar mechanism of creating microchannels in the dermis that allow for collagen remodeling. Furthermore, microneedling has been demonstrated to induce a specific cytokine profile including fibroblast-like growth factor, vascular endothelial growth factor, epidermal growth factor, and transforming growth factor-beta3 which are associated with favorable wound healing.
More recently, experts have advocated for the use of electric-powered microneedling devices which allow for more controlled injury at a set depth, density, and speed for the treatment of atrophic acne scars with good results.
To the investigators' knowledge, this study will be the first of its kind to compare the efficacy and safety of a combination of 1,550-nm erbium-doped fractional laser and microneedling with the SkinPenTM device to 1,550-nm erbium-doped fractional laser alone in the treatment of atrophic acne scars.
Both treatment modalities in this study are already FDA approved treatment modalities for acne scarring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized split-face clinical trial
| Arm | Type | Receives |
|---|---|---|
| Non-ablative Fractional Laser | Active comparator | Device: Fraxel Restore (Non-ablative Fractional Laser)Non-ablative fractional laser (brand name Fraxel Restore) only on one half of the face. |
| Non-ablative Fractional Laser Plus Microneedling | Active comparator | Device: Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device)Non-ablative fractional laser (brand name Fraxel Restore) in combination with a microneedling device (SkinPen) on the other half of the face. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All gender patients
- Age older than 18 years
- Fitzpatrick skin types I-III
- Facial acne scarring of grades III-IV
- Both sides of the face should have similar amount and severity of acne scarring
Key exclusion criteria (9 listed)
- History of keloidal scarring
- Localized or active infection in the treatment region
- Immunodeficiency disorders
- Porphyria or light sensitivity
- Connective tissue disorders.
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 |
|---|---|---|
| Fraxel Restore (Non-ablative Fractional Laser)In the study, one side of the face will be treated with non-ablative fractional laser monthly for three months. | Device | Non-ablative Fractional Laser |
| Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device)In the study, one side of the face will be treated with a combination of non-ablative fractional laser and microneedling monthly for three months. | Device | Non-ablative Fractional Laser Plus Microneedling |
Primary outcome
Improvement in acne scarring
Time frame: 20 weeks
Two blinded evaluators will use standardized digital photographic review to grade acne scar improvement on a quartile grading scale (1 = 1% to 25%, 2 = 26 to 50%, 3 = 51 to 75%, 4 = >76% improvement).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- 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.
Mathew Avram, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fraxel Restore (Non-ablative Fractional Laser) and Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device) in people with Acne Scars, run by Massachusetts General Hospital 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Jan 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?
Results are not available in the source record.
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?
Improvement in acne scarring (time frame: 20 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 28 Jan 2020.