Acne ScarsNCT03380845
Comparison of 1,550-nm Laser and Fractional Radiofrequency Microneedle for the Treatment of Acne Scars in Ethnic Skin
A study testing Fraxel Restore and Fractora in people with Acne Scars, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary objective of this randomized, split-face, controlled study is to compare the efficacy and safety of a erbium-doped 1,550-nm non-ablative fractional laser and a bipolar fractional radiofrequency microneedle device for the treatment of atrophic facial acne scars in ethnic skin (Fitzpatrick Skin Phototypes… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Scars
- What is being tested?
- Fraxel Restore and Fractora
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2018to 30 Oct 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women with Fitzpatrick skin types III through VI and facial acne scarring of grades III-IV will be enrolled. Both sides of the participants' face should have almost similar amount and severity of acne scarring. Participants will be over 18 years old
Who cannot join
- Patients have to be overall healthy without a history of keloidal scarring, localized or active infection in the treatment region, immunodeficiency disorders, porphyria or light sensitivity, and connective tissue disorders. Per PI discretion, any serious medical condition that may interfere with the study. In addition, pregnant or nursing women, patients who have been taking isotretinoin for a period of 6 months before treatment, and patients who have received any cosmetic treatment (lasers, dermabrasion, chemical peels, etc) in the previous 6 months will be excluded. Also, patients with renal disease, and any allergies to Lidocaine, Tetracaine, or Valtrex will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Comparison of Fractional Erbium-Doped 1,550-nm Laser and a Bipolar Fractional Radiofrequency Microneedle Device for the Treatment of Atrophic Acne Scars in Ethnic Skin: A Randomized Split-Face Controlled Pilot Study
The primary objective of this randomized, split-face, controlled study is to compare the efficacy and safety of a erbium-doped 1,550-nm non-ablative fractional laser and a bipolar fractional radiofrequency microneedle device for the treatment of atrophic facial acne scars in ethnic skin (Fitzpatrick Skin Phototypes III-VI).
The hypothesis of this study is that both erbium-doped 1,550-nm non-ablative fractional laser and the bipolar fractional radiofrequency microneedle device are equally effective for the treatment of atrophic acne scars in ethnic skin (SPT III-VI). However, the bipolar fractional radiofrequency microneedle device has less adverse effects than erbium-doped 1,550-nm non-ablative fractional laser due to the absence of scattering and the absence of chromophore-specific targets - predominantly melanin - traditionally needed with laser treatments; hence the fractional radiofrequency microneedle device will have a higher safety profile in darker skin types .
Read the detailed description
Acne is a highly prevalent disease and post-acne scaring has shown to have detrimental effects on a person's physical, mental, and social well-being. Acne scars can be divided in general categories of hypertrophic or keloid scars, atrophic scars (icepick, rolling, boxcar), and pigmentation alterations (redness, hypo and hyper-pigmentation). This study will focus on treatment of moderate to severe grades of atrophic acne scarring. Our aim is to compare the efficacy and safety of a erbium-doped 1,550-nm non-ablative fractional laser and a bipolar fractional radiofrequency microneedle device for the treatment of atrophic acne scars in ethnic skin (Fitzpatrick Skin Phototypes III-VI) by performing a split-face randomized controlled trial.
Both devices in this study are already FDA approved treatment modalities for acne scarring.
History of erbium-doped 1,550-nm non-ablative fractional laser (Fraxel® Restore Laser System, Solta Medical, Inc., Hayward, CA):
Non-ablative fractional lasers work via the theory of fractional photothermolysis, which creates hundreds to thousands of microscopic thermal zones (MTZs), or columns of thermally injured skin, while sparing the surrounding tissue. The pixilated nature of treatment and the functionally unimpaired stratum corneum allow for rapid tissue healing and allows for safer treatments of our patients. Mechanistically, fractional photothermolysis allows controlled amounts of high energy to be delivered deep within the dermis resulting in collagenolysis and neocollagenesis, which smoothes the textural abnormalities of acne scarring.
Multiple published studies have demonstrated that erbium-doped 1,550-nm non-ablative fractional laser ("NAFL") can be successfully utilized in the treatment of all forms of atrophic acne scarring - ice-pick, boxcar, and rolling scars - with a very favorable safety profile in all skin types, and thus, has been cleared by Food and Drug Administration (FDA) for that particular indication. According to the manufacture manual (reference attached in the "Attachments" section), NAFL is indicated for "use in skin resurfacing procedures as well as treatment of acne scars, surgical scars, lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma."
History of the fractional radiofrequency microneedle device (Fractora; Invasix Ltd./InMode MD Ltd., Israel):
Fractional radiofrequency is not a laser. Instead, these devices use an array of electrodes that allows for zones of thermal wounds to be created between areas of unaffected zones, thus stimulating dermal remodeling and allowing for a supply of reservoir cells to promote healing. Variations of fractional radiofrequency exist that employ microneedles to deliver electrical current to a particular depth within the dermis that decreases damage to the epidermis. These fractional radiofrequency microneedle devices provide an alternative to conventional methods of acne-scar treatment (such as NAFL). Great interest has been culminating over the recent years for the use of such devices in acne scars due to the absence of light scattering and the absence of chromophore-specific targets traditionally needed with laser treatments. As melanin is not a target, it is felt to have a higher safety profile in darker skin phototypes.
A recent study investigated the safety and efficacy of a specific bipolar fractional radiofrequency microneedle device (Fractora; Invasix Ltd./InMode MD Ltd., Israel) for acne and acne scarring. In this study, 8 patients with acne scars were reported and it was noted that all patients (regardless of their skin phototypes) had improvement in their active acne and acne scars after 4 treatments and a 1 month, on average follow-up period. The treatment was well tolerated without any side-effects. Skin biopsies from this study showed reduction in scar depth and new collagen formation with an increase in elastic fibers and adnexal structures noted. A follow-up report showed that 4 out of 8 patients who were in the original study returned for a long term follow-up from 1 to 2 years, that showed ongoing clinical improvements in these patients. This specific bipolar fractional radiofrequency microneedle ("FRM") device has been FDA-approved for acne scars and skin rejuvenation.
To this date the efficacy and safety of 1,550-nm fractionated photothermolysis system has not been compared to a fractional radiofrequency microneedle device for atrophic acne scars in ethnic skin in a randomized split-face controlled trial. A major advantage of a split-face self-controlled design would be to minimize any confounding factors. Laser resurfacing has been well studied and is widely used in individuals with fair skin - Fitzpatrick skin phototypes (SPT) I to II. However, there is a paucity of published studies involving individuals with darker skin types (SPT III-VI)-a population that has a higher risk of laser-associated dyspigmentation.
- Conditions
- Acne Scars
- Being tested
- Fraxel Restore, Fractora
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fraxel RestoreDevice
Non-ablative Laser. In the study, one side of the face will be treated with Fraxel Restore monthly for three months.
FractoraDevice
Fractional Radiofrequency Microneedling Device. In the study, one side of the face will be treated with Fractora monthly for three months.
| Study group | Role | What they receive |
|---|---|---|
| Fraxel Restore on one side of the face | Active comparator | Fraxel Restore on one side of the face
Fraxel Restore: acne scar correction
Randomized treatment with Fraxel Restore on one side of the face, and Fractora on the opposite side of the face - the study is a randomized,single-center, split-face study in subjects seeking acne scar correction. Subjects were treated with Fraxel on one side of the face and Fractora on the other side of the face. The side of the face for each device was randomly assigned. Receives: Device: Fraxel Restore |
| Fractora on the other side of the face | Active comparator | Fractora on the other side of the face
Fractora: acne scar correction
Randomized treatment with Fraxel Restore on one side of the face, and Fractora on the opposite side of the face - the study is a randomized,single-center, split-face study in subjects seeking acne scar correction. Subjects were treated with Fraxel on one side of the face and Fractora on the other side of the face. The side of the face for each device was randomly assigned. Receives: Device: Fractora |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Acne Scarring - From Baseline to Three Months After Last Treatment
Improvement in acne scarring will be measured by two blinded evaluators both by in-person assessments and by photographic review (digital photography will be used under standardized conditions). A quartile grading scale (1 = 1% to 25%, 2 =26% to 50%, 3 =51% to 75%, 4 = >76% improvement) will be used to measure acne scar improvement. Higher score means better outcome.
Measured: three months after last treatment
Secondary outcomes (2)
Comparing Side Effects of the Different Lasers
measure side effects by patient reported adverse events and blinded physician assessment of adverse effects. Parameters, include erythema, edema, blistering, crusting, scarring, hypopigmentation, and hyperpigmentation, will be graded on a 4-point scale (0 = absent, 1= mild, 2 = moderate, and 3 = severe). Higher score means worse outcome.
Measured: treatment visit 1, treatment visit 2, treatment visit 3, three months after last treatment
Comparing Intensity of Pain With the Different Lasers
Patients will also be evaluated the intensity of pain using a visual analogue scale (0 = absence of pain, 10 = most-severe pain). Higher score means worse outcome
Measured: treatment visit 1, treatment visit 2, treatment visit 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start16 Mar 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 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 (10)Papers the sponsor has linked to this study.
- 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
- Single group
- Model description
- Randomized split-face clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Dermatologic Surgery
- Responsible party
- Principal investigator, Mathew Avram, MD, JD, Massachusetts General Hospital
- Investigators
- Mathew Avram, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380845
- Sponsor's protocol ID
- 2017P002061
- Status last verified
- Nov 2019
- First submitted
- 8 Dec 2017
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Purvis D, Robinson E, Merry S, Watson P. Acne, anxiety, depression and suicide in teenagers: a cross-sectional survey of New Zealand secondary school students. J Paediatr Child Health. 2006 Dec;42(12):793-6. doi: 10.1111/j.1440-1754.2006.00979.x.
PubMed 17096715Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
PubMed 15216537Alster TS, Tanzi EL, Lazarus M. The use of fractional laser photothermolysis for the treatment of atrophic scars. Dermatol Surg. 2007 Mar;33(3):295-9. doi: 10.1111/j.1524-4725.2007.33059.x.
PubMed 17338686Chrastil B, Glaich AS, Goldberg LH, Friedman PM. Second-generation 1,550-nm fractional photothermolysis for the treatment of acne scars. Dermatol Surg. 2008 Oct;34(10):1327-32. doi: 10.1111/j.1524-4725.2008.34284.x.
PubMed 19040687Mahmoud BH, Srivastava D, Janiga JJ, Yang JJ, Lim HW, Ozog DM. Safety and efficacy of erbium-doped yttrium aluminum garnet fractionated laser for treatment of acne scars in type IV to VI skin. Dermatol Surg. 2010 May;36(5):602-9. doi: 10.1111/j.1524-4725.2010.01513.x. Epub 2010 Apr 1.
PubMed 20384757Alexis AF, Coley MK, Nijhawan RI, Luke JD, Shah SK, Argobi YA, Nodzenski M, Veledar E, Alam M. Nonablative Fractional Laser Resurfacing for Acne Scarring in Patients With Fitzpatrick Skin Phototypes IV-VI. Dermatol Surg. 2016 Mar;42(3):392-402. doi: 10.1097/DSS.0000000000000640.
PubMed 26945321Hruza G, Taub AF, Collier SL, Mulholland SR. Skin rejuvenation and wrinkle reduction using a fractional radiofrequency system. J Drugs Dermatol. 2009 Mar;8(3):259-65.
PubMed 19271373Chandrashekar BS, Sriram R, Mysore R, Bhaskar S, Shetty A. Evaluation of microneedling fractional radiofrequency device for treatment of acne scars. J Cutan Aesthet Surg. 2014 Apr;7(2):93-7. doi: 10.4103/0974-2077.138328.
PubMed 25136209Chae WS, Seong JY, Jung HN, Kong SH, Kim MH, Suh HS, Choi YS. Comparative study on efficacy and safety of 1550 nm Er:Glass fractional laser and fractional radiofrequency microneedle device for facial atrophic acne scar. J Cosmet Dermatol. 2015 Jun;14(2):100-6. doi: 10.1111/jocd.12139. Epub 2015 Mar 23.
PubMed 25810322Abdel Hay R, Shalaby K, Zaher H, Hafez V, Chi CC, Dimitri S, Nabhan AF, Layton AM. Interventions for acne scars. Cochrane Database Syst Rev. 2016 Apr 3;4(4):CD011946. doi: 10.1002/14651858.CD011946.pub2.
PubMed 27038134
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fractional Erbium-Doped 1,550-nm Laser and a Bipolar Fractional Radiofrequency Microneedle Device for the Treatment of Atrophic Acne Scars in Ethnic Skin: A Randomized Split-Face Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03380845
- Acronym / sponsor ID
- 2017P002061
- Conditions
- Acne Scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Society for Dermatologic Surgery
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Posted 19 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this randomized, split-face, controlled study is to compare the efficacy and safety of a erbium-doped 1,550-nm non-ablative fractional laser and a bipolar fractional radiofrequency microneedle device for the treatment of atrophic facial acne scars in ethnic skin (Fitzpatrick Skin Phototypes III-VI).
The hypothesis of this study is that both erbium-doped 1,550-nm non-ablative fractional laser and the bipolar fractional radiofrequency microneedle device are equally effective for the treatment of atrophic acne scars in ethnic skin (SPT III-VI). However, the bipolar fractional radiofrequency microneedle device has less adverse effects than erbium-doped 1,550-nm non-ablative fractional laser due to the absence of scattering and the absence of chromophore-specific targets - predominantly melanin - traditionally needed with laser treatments; hence the fractional radiofrequency microneedle device will have a higher safety profile in darker skin types .
Detailed description
Acne is a highly prevalent disease and post-acne scaring has shown to have detrimental effects on a person's physical, mental, and social well-being. Acne scars can be divided in general categories of hypertrophic or keloid scars, atrophic scars (icepick, rolling, boxcar), and pigmentation alterations (redness, hypo and hyper-pigmentation). This study will focus on treatment of moderate to severe grades of atrophic acne scarring. Our aim is to compare the efficacy and safety of a erbium-doped 1,550-nm non-ablative fractional laser and a bipolar fractional radiofrequency microneedle device for the treatment of atrophic acne scars in ethnic skin (Fitzpatrick Skin Phototypes III-VI) by performing a split-face randomized controlled trial.
Both devices in this study are already FDA approved treatment modalities for acne scarring.
History of erbium-doped 1,550-nm non-ablative fractional laser (Fraxel® Restore Laser System, Solta Medical, Inc., Hayward, CA):
Non-ablative fractional lasers work via the theory of fractional photothermolysis, which creates hundreds to thousands of microscopic thermal zones (MTZs), or columns of thermally injured skin, while sparing the surrounding tissue. The pixilated nature of treatment and the functionally unimpaired stratum corneum allow for rapid tissue healing and allows for safer treatments of our patients. Mechanistically, fractional photothermolysis allows controlled amounts of high energy to be delivered deep within the dermis resulting in collagenolysis and neocollagenesis, which smoothes the textural abnormalities of acne scarring.
Multiple published studies have demonstrated that erbium-doped 1,550-nm non-ablative fractional laser ("NAFL") can be successfully utilized in the treatment of all forms of atrophic acne scarring - ice-pick, boxcar, and rolling scars - with a very favorable safety profile in all skin types, and thus, has been cleared by Food and Drug Administration (FDA) for that particular indication. According to the manufacture manual (reference attached in the "Attachments" section), NAFL is indicated for "use in skin resurfacing procedures as well as treatment of acne scars, surgical scars, lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma."
History of the fractional radiofrequency microneedle device (Fractora; Invasix Ltd./InMode MD Ltd., Israel):
Fractional radiofrequency is not a laser. Instead, these devices use an array of electrodes that allows for zones of thermal wounds to be created between areas of unaffected zones, thus stimulating dermal remodeling and allowing for a supply of reservoir cells to promote healing. Variations of fractional radiofrequency exist that employ microneedles to deliver electrical current to a particular depth within the dermis that decreases damage to the epidermis. These fractional radiofrequency microneedle devices provide an alternative to conventional methods of acne-scar treatment (such as NAFL). Great interest has been culminating over the recent years for the use of such devices in acne scars due to the absence of light scattering and the absence of chromophore-specific targets traditionally needed with laser treatments. As melanin is not a target, it is felt to have a higher safety profile in darker skin phototypes.
A recent study investigated the safety and efficacy of a specific bipolar fractional radiofrequency microneedle device (Fractora; Invasix Ltd./InMode MD Ltd., Israel) for acne and acne scarring. In this study, 8 patients with acne scars were reported and it was noted that all patients (regardless of their skin phototypes) had improvement in their active acne and acne scars after 4 treatments and a 1 month, on average follow-up period. The treatment was well tolerated without any side-effects. Skin biopsies from this study showed reduction in scar depth and new collagen formation with an increase in elastic fibers and adnexal structures noted. A follow-up report showed that 4 out of 8 patients who were in the original study returned for a long term follow-up from 1 to 2 years, that showed ongoing clinical improvements in these patients. This specific bipolar fractional radiofrequency microneedle ("FRM") device has been FDA-approved for acne scars and skin rejuvenation.
To this date the efficacy and safety of 1,550-nm fractionated photothermolysis system has not been compared to a fractional radiofrequency microneedle device for atrophic acne scars in ethnic skin in a randomized split-face controlled trial. A major advantage of a split-face self-controlled design would be to minimize any confounding factors. Laser resurfacing has been well studied and is widely used in individuals with fair skin - Fitzpatrick skin phototypes (SPT) I to II. However, there is a paucity of published studies involving individuals with darker skin types (SPT III-VI)-a population that has a higher risk of laser-associated dyspigmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized split-face clinical trial
| Arm | Type | Receives |
|---|---|---|
| Fraxel Restore on one side of the face | Active comparator | Device: Fraxel RestoreFraxel Restore on one side of the face Fraxel Restore: acne scar correction Randomized treatment with Fraxel Restore on one side of the face, and Fractora on the opposite side of the face - the study is a randomized,single-center, split-face study in subjects seeking acne scar correction. Subjects were treated with Fraxel on one side of the face and Fractora on the other side of the face. The side of the face for each device was randomly assigned. |
| Fractora on the other side of the face | Active comparator | Device: FractoraFractora on the other side of the face Fractora: acne scar correction Randomized treatment with Fraxel Restore on one side of the face, and Fractora on the opposite side of the face - the study is a randomized,single-center, split-face study in subjects seeking acne scar correction. Subjects were treated with Fraxel on one side of the face and Fractora on the other side of the face. The side of the face for each device was randomly assigned. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women with Fitzpatrick skin types III through VI and facial acne scarring of grades III-IV will be enrolled. Both sides of the participants' face should have almost similar amount and severity of acne scarring. Participants will be over 18 years old
Key exclusion criteria (1 listed)
- Patients have to be overall healthy without a history of keloidal scarring, localized or active infection in the treatment region, immunodeficiency disorders, porphyria or light sensitivity, and connective tissue disorders. Per PI discretion, any serious medical condition that may interfere with the study. In addition, pregnant or nursing women, patients who have been taking isotretinoin for a period of 6 months before treatment, and patients who have received any cosmetic treatment (lasers, dermabrasion, chemical peels, etc) in the previous 6 months will be excluded. Also, patients with renal disease, and any allergies to Lidocaine, Tetracaine, or Valtrex will be excluded.
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 RestoreNon-ablative Laser. In the study, one side of the face will be treated with Fraxel Restore monthly for three months. | Device | Fraxel Restore on one side of the face |
| FractoraFractional Radiofrequency Microneedling Device. In the study, one side of the face will be treated with Fractora monthly for three months. | Device | Fractora on the other side of the face |
Primary outcome
Improvement in Acne Scarring - From Baseline to Three Months After Last Treatment
Time frame: three months after last treatment
Improvement in acne scarring will be measured by two blinded evaluators both by in-person assessments and by photographic review (digital photography will be used under standardized conditions). A quartile grading scale (1 = 1% to 25%, 2 =26% to 50%, 3 =51% to 75%, 4 = >76% improvement) will be used to measure acne scar improvement. Higher score means better outcome.
2 secondary outcomes
Comparing Side Effects of the Different Lasers
Time frame: treatment visit 1, treatment visit 2, treatment visit 3, three months after last treatment
Comparing Intensity of Pain With the Different Lasers
Time frame: treatment visit 1, treatment visit 2, treatment visit 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17096715Purvis D, Robinson E, Merry S, Watson P. Acne, anxiety, depression and suicide in teenagers: a cross-sectional survey of New Zealand secondary school students. J Paediatr Child Health. 2006 Dec;42(12):793-6. doi: 10.1111/j.1440-1754.2006.00979.x.
- Background: PubMed 15216537Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
- Background: PubMed 17338686Alster TS, Tanzi EL, Lazarus M. The use of fractional laser photothermolysis for the treatment of atrophic scars. Dermatol Surg. 2007 Mar;33(3):295-9. doi: 10.1111/j.1524-4725.2007.33059.x.
- Background: PubMed 19040687Chrastil B, Glaich AS, Goldberg LH, Friedman PM. Second-generation 1,550-nm fractional photothermolysis for the treatment of acne scars. Dermatol Surg. 2008 Oct;34(10):1327-32. doi: 10.1111/j.1524-4725.2008.34284.x.
- Background: PubMed 20384757Mahmoud BH, Srivastava D, Janiga JJ, Yang JJ, Lim HW, Ozog DM. Safety and efficacy of erbium-doped yttrium aluminum garnet fractionated laser for treatment of acne scars in type IV to VI skin. Dermatol Surg. 2010 May;36(5):602-9. doi: 10.1111/j.1524-4725.2010.01513.x. Epub 2010 Apr 1.
- Background: PubMed 26945321Alexis AF, Coley MK, Nijhawan RI, Luke JD, Shah SK, Argobi YA, Nodzenski M, Veledar E, Alam M. Nonablative Fractional Laser Resurfacing for Acne Scarring in Patients With Fitzpatrick Skin Phototypes IV-VI. Dermatol Surg. 2016 Mar;42(3):392-402. doi: 10.1097/DSS.0000000000000640.
- Background: PubMed 19271373Hruza G, Taub AF, Collier SL, Mulholland SR. Skin rejuvenation and wrinkle reduction using a fractional radiofrequency system. J Drugs Dermatol. 2009 Mar;8(3):259-65.
- Background: PubMed 25136209Chandrashekar BS, Sriram R, Mysore R, Bhaskar S, Shetty A. Evaluation of microneedling fractional radiofrequency device for treatment of acne scars. J Cutan Aesthet Surg. 2014 Apr;7(2):93-7. doi: 10.4103/0974-2077.138328.
- Background: PubMed 25810322Chae WS, Seong JY, Jung HN, Kong SH, Kim MH, Suh HS, Choi YS. Comparative study on efficacy and safety of 1550 nm Er:Glass fractional laser and fractional radiofrequency microneedle device for facial atrophic acne scar. J Cosmet Dermatol. 2015 Jun;14(2):100-6. doi: 10.1111/jocd.12139. Epub 2015 Mar 23.
- Background: PubMed 27038134Abdel Hay R, Shalaby K, Zaher H, Hafez V, Chi CC, Dimitri S, Nabhan AF, Layton AM. Interventions for acne scars. Cochrane Database Syst Rev. 2016 Apr 3;4(4):CD011946. doi: 10.1002/14651858.CD011946.pub2.
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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
MGH
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 and Fractora 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 1 inclusion and 1 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 19 Nov 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 19 Nov 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?
Improvement in Acne Scarring - From Baseline to Three Months After Last Treatment (time frame: three months after last treatment). 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 NCT03380845, which also lists 10 linked publications.
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 19 Nov 2019.