Combined Therapy for Acne Scars

Study Overview
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Brief Summary
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Compare the effectiveness of nonablative fractional resurfacing to radiofrequency micrnoeedling for facial acne scars in all skin types

Detailed Description
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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.

Official Title
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Combined Treatment With Nonablative Fractional Laser and Radiofrequency Microneedling for the Treatment of Acne Scars: A Prospective, Randomized, Split-Face Study

Conditions
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Atrophic Acne Scar

Intervention / Treatment
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* Device: Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone
* Device: Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Male or female in general good health ages 18 and older Fitzpatrick skin type I-VI Subject has completed an appropriately administered informed consent process which includes signing the IRB approved consent form Negative urine pregnancy test at baseline (if applicable) Willingness to have facial exams and digital photos performed of the face Moderate to severe atrophic acne scarring on the face per ECCA (échelle d'évaluation clinique des cicatrices d'acné) acne grading scale No change in estrogen releasing contraceptive method in 3 months, and no plans to change this contraceptive method during the course of the study No change in topical skin care Female patients will be either of non-childbearing potential defined as: Having no uterus 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: Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device Intrauterine coil Bilateral tubal ligation Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom) Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active). Vasectomized partner (Must agree to use barrier method described above (4) if becomes sexually active with non-vasectomized). Exclusion criteria Presence of incompletely healed wound in treatment area Pregnant, planning pregnancy or breastfeeding during the course of the study Energy-based device treatment in the treatment area in the last 6 months Treatments with a dermal filler or biostimulatory agent in the treatment area within the past 12 months 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. Individuals who have had a chemical peel or microdermabrasion of the face within 30 days prior to enrollment in the study 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 Has skin with open wounds, excessively sensitive skin, neurotic excoriations, dermatitis or inflammatory rosacea in the treatment area 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) 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 Subjects who participated on another study within the last 30 days Subjects currently on or planning to participate in any type of research study at another facility or a doctor's office during this study Subjects with a predisposition to keloid formation following surgery 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, split-face, evaluator-blinded study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nonablative fractional laser alone<br> | Device: Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone<br>* 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.<br>|
| Experimental: Nonablative fractional laser alternating with microneedling with radiofrequency<br> | Device: Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone<br>* 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.<br>Device: Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in atrophic acne scar | 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. | 3 months after final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject comfort level | During each treatment visit patients will be asked to grade pain of treatment on a pain visual analog scale. | To be done right after treatments | 
| Subjective change | Subjects will rate their perceived global change in acne scarring based on the subjected assessed global improvement scale. | 3 months after final treatment | 
| Subject satisfaction | Subjects will rate satisfaction on a 1-5 scale. | 3 months after final treatment | 
| Adverse events | To be recorded by treating physician after treatment. | 3 months after final treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne, Acne scar, Face, Microneedling, Intracel, Fraxel