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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03380845
Other study ID # 2017P002061
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 16, 2018
Est. completion date October 30, 2018

Study information

Verified date November 2019
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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 .


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fraxel Restore
Non-ablative Laser. In the study, one side of the face will be treated with Fraxel Restore monthly for three months.
Fractora
Fractional Radiofrequency Microneedling Device. In the study, one side of the face will be treated with Fractora monthly for three months.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital American Society for Dermatologic Surgery

Country where clinical trial is conducted

United States, 

References & Publications (10)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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. three months after last treatment
Secondary 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. treatment visit 1, treatment visit 2, treatment visit 3, three months after last treatment
Secondary 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 treatment visit 1, treatment visit 2, treatment visit 3
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