Atrophic Acne Scar
Conditions
Keywords
Acne, Acne scar, Face, Microneedling, Intracel, Fraxel
Brief summary
Compare the effectiveness of nonablative fractional resurfacing to radiofrequency micrnoeedling for facial acne scars in all skin types
Detailed description
Quantify and compare the effectiveness of nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone to nonablative fractional laser alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA) for the treatment of atrophic, facial acne scars in all skin types.
Interventions
DEVICENonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone
Nonablative fractional 1550 nm erbium:glass laser. Settings: 40-70 mJ, treatment level 5-7 (14-20% coverage), 8 passes with cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5. To be repeated for a total of 4 sessions at 4-week intervals.
DEVICENonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA)
Nonablative fractional 1550 nm erbium:glass laser. Settings: 40-70 mJ, treatment level 5-7 (14-20% coverage), 8 passes with cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5. This will be alternated with radiofrequency microneedling treatment will include 3 passes each at a depth of 2 mm, 1.5 mm, and 0.8 mm, treatment level 5 (32 w, 50 ms)-7 (40 w, 60 ms), monopolar setting with cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5. To be repeated for a total of 4 sessions (2 of each modality) at 4-week intervals.
Sponsors
Goldman, Butterwick, Fitzpatrick and Groff
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical assessments and grading of severity of acne scarring will be performed by blinded-investigator assessment at each visit and at the post-treatment 3-month visit using live evaluations and photographs. At the 3-month follow up, three additional blinded dermatologists will clinically assess the severity of acne scarring.
Intervention model description
Prospective, randomized, split-face, evaluator-blinded study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Inclusion criteria 1. Male or female in general good health ages 18 and older 2. Fitzpatrick skin type I-VI 3. Subject has completed an appropriately administered informed consent process which includes signing the IRB approved consent form 4. Negative urine pregnancy test at baseline (if applicable) 5. Willingness to have facial exams and digital photos performed of the face 6. Moderate to severe atrophic acne scarring on the face per ECCA (échelle d'évaluation clinique des cicatrices d'acné) acne grading scale 7. No change in estrogen releasing contraceptive method in 3 months, and no plans to change this contraceptive method during the course of the study 8. No change in topical skin care 9. Female patients will be either of non-childbearing potential defined as: 1. Having no uterus 2. No menses for at least 12 months. Or; Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study, such as: <!-- --> 1. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device 2. Intrauterine coil 3. Bilateral tubal ligation 4. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom) 5. Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active). 6. Vasectomized partner (Must agree to use barrier method described above (4) if becomes sexually active with non-vasectomized). 2.
Exclusion criteria
1. Presence of incompletely healed wound in treatment area 2. Pregnant, planning pregnancy or breastfeeding during the course of the study 3. Energy-based device treatment in the treatment area in the last 6 months 4. Treatments with a dermal filler or biostimulatory agent in the treatment area within the past 12 months 5. Recent use of topical tretinoin, adapalene, tazarotene, hydroquinone, imiquimod, 5-fluorouracil, ingenol mebutate, concentrated hydrogen peroxide or diclofenac to the face within the previous 2 weeks. 6. Individuals who have had a chemical peel or microdermabrasion of the face within 30 days prior to enrollment in the study 7. Co-existing potentially confounding skin condition within treatment area (e.g. eczema, psoriasis, XP, rosacea) or the presence of suspected BCC or SCC in treatment area at investigator's discretion 8. Has skin with open wounds, excessively sensitive skin, neurotic excoriations, dermatitis or inflammatory rosacea in the treatment area 9. Individuals with known allergies or sensitivities to any of the ingredients of any topical products being used in this study (a list of the products with active and excipients will be provided below) 10. Individuals with active psoriasis, eczema, sunburn, excessive scarring, tattoos, or other skin condition on the face that would interfere with the assessments of this study 11. Subjects who participated on another study within the last 30 days 12. Subjects currently on or planning to participate in any type of research study at another facility or a doctor's office during this study 13. Subjects with a predisposition to keloid formation following surgery 14. Subjects on systemic steroids (e.g. prednisone, dexamethasone), or topical steroids on the face which should be rigorously avoided prior to and throughout the course of treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in atrophic acne scar | 3 months after final treatment | The primary study endpoint will be clinical efficacy defined as change in atrophic acne scarring based on the ECCA grading scale and a 1-10 percentile scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject comfort level | To be done right after treatments | During each treatment visit patients will be asked to grade pain of treatment on a pain visual analog scale. |
| Subjective change | 3 months after final treatment | Subjects will rate their perceived global change in acne scarring based on the subjected assessed global improvement scale. |
| Subject satisfaction | 3 months after final treatment | Subjects will rate satisfaction on a 1-5 scale. |
| Adverse events | 3 months after final treatment | To be recorded by treating physician after treatment. |
Contacts
Primary ContactSherif Mikhail, MD
Backup ContactAndrea Pacheco
Outcome results
None listed