N/A
N=4
Comparison of 1,550-nm Laser and Fractional Radiofrequency Microneedle for the Treatment of Acne Scars in Ethnic Skin
Acne Scars
Bottom Line
View on ClinicalTrials.gov: NCT03380845 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Improvement in Acne Scarring - From Baseline to Three Months After Last Treatment — 2; 2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fraxel Restore (Device); Fractora (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Acne Scarring - From Baseline to Three Months After Last Treatment |
2; 2 | — |
| SECONDARY Comparing Side Effects of the Different Lasers |
0; 0 | — |
| SECONDARY Comparing Intensity of Pain With the Different Lasers |
3; 7 | — |
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 .
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03380845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.