CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4 enrolled
Drug / intervention
Fraxel Restore +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03380845
NCT03380845N/ACompleted

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

Massachusetts General Hospital·interventional·Posted Dec 21, 2017·Updated Nov 19, 2019

In Brief

A clinical study evaluating Fraxel Restore and Fractora for Acne Scars. Completed, enrolled 4 participants across 1 site.

Detailed 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 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 .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Scars
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 21, 2017
Enrollment StartMar 16, 2018
Primary CompletionOct 30, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.5 years ago

Interventions

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.