Comparison of 1,550-nm Laser and Fractional Radiofrequency Microneedle for the Treatment of Acne Scars in Ethnic Skin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03380845|
Recruitment Status : Not yet recruiting
First Posted : December 21, 2017
Last Update Posted : December 21, 2017
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 .
|Condition or disease||Intervention/treatment||Phase|
|Acne Scars||Device: Fraxel Restore Device: Fractora||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized split-face clinical trial|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Estimated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Fraxel Restore
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 "Documents and 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."
Fraxel Restore to be done on one side of the face monthly for three months.
Device: Fraxel Restore
Non-ablative Laser. In the study, one side of the face will be treated with Fraxel Restore monthly for three months.
Active Comparator: Fractora
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. 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.
Fractora to be done on one side of the face monthly for three months.
Fractional Radiofrequency Microneedling Device. In the study, one side of the face will be treated with Fractora monthly for three months.
- Improvement in acne scarring [ Time Frame: 3 months after the 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.
- Comparing side effects of the different lasers [ Time Frame: 6 months ]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).
- Comparing intensity of pain with the different lasers [ Time Frame: 6 months ]Patients will also be evaluated the intensity of pain using a visual analogue scale (0 = absence of pain, 10 = most-severe pain).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380845
|Contact: Sandeep Saluja, MDemail@example.com|
|Contact: Mathew Avram, MDfirstname.lastname@example.org|
|Principal Investigator:||Mathew Avram, MD||MGH|