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NCT03380845 · ClinicalTrials.gov registry record · NA
Comparison of 1,550-nm Laser and Fractional Radiofrequency Microneedle for the Treatment of Acne Scars in Ethnic Skin
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT03380845: Completed NA study, sponsored by Massachusetts General Hospital.
NCT03380845 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03380845, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study 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 .
Primary Outcome
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.
Interventions
- DEVICE Fraxel Restore
- DEVICE Fractora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-03-16 |
| Est. Completion | 2018-10-30 |
| Phase | NA |
What the finished NCT03380845 record still lists
NCT03380845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Fraxel Restore is the first listed.
NCT03380845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03380845 about?
NCT03380845 is a clinical study titled "Comparison of 1,550-nm Laser and Fractional Radiofrequency Microneedle for the Treatment of Acne Scars in Ethnic Skin". 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...
What is the current status of trial NCT03380845?
This trial is currently completed. It is a NA study. The enrollment target is 4 participants. The study started on 2018-03-16. Estimated completion is 2018-10-30.
What interventions are being tested in trial NCT03380845?
The interventions under investigation include: Fraxel Restore (DEVICE), Fractora (DEVICE).
Who is sponsoring clinical trial NCT03380845?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03380845's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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