Cicatrix
Conditions
Brief summary
The purpose of this study is to compare the effectiveness of the ePrime fractional radiofrequency system to the 1550-nm fractional photothermolysis system (Fraxel) in the ability to improve acne scar appearance.
Detailed description
Participants in this study will be patients at the dermatology clinic with icepick and boxcar acne scars on at least one 2 x 2 cm area on each side of face. Subjects will be randomly assigned to receive fractional radiofrequency treatment to either the right or left side of the face and the contralateral side will receive 1550-nm fractional photothermolysis. Subjects will receive treatments at baseline, week 4, and week 8 for a total of three treatments. Follow up visits will take place at week 16, two months following the last treatment visit. This study is a pilot study designed to determine feasibility of these procedures.
Interventions
DEVICE1550-nm Fractional Photothermolysis
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects age 18 years and older. 2. Subjects with bilateral 2x2 cm areas of ice pick and/or boxcar acne scars on their face. 3. Subjects are in good health. 4. Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.
Exclusion criteria
1. Subjects who have received injectable soft-tissue augmentation materials to the face, or facial ablative resurfacing, within the past 6 months. 2. Subjects who have received injectable botulinum toxin to the face, or any nonablative laser treatment to the face, within the past 3 months. 3. Subjects who have local infections, open facial wounds, or other significant local skin disease that would interfere with acne scar treatment with energy devices. 4. Subjects who are allergic to lidocaine or prilocaine. 5. Subjects who have a history of abnormal scarring in the treatment area, such as keloid scar formation. 6. Subjects who have ectropion or or other eyelid disfigurement. 7. Subjects who have a history of isotretinoin use in the preceding year. 8. Pregnant or lactating individuals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16 | 1 hour at baseline and week 16 | The primary outcome was a blinded rating of the treatment area (Fractional Radiofrequency Versus Fractional Photothermolysis) with the best cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 16). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMurad Alam, MD
Northwestern University
Outcome results
None listed