Combined Therapy for Acne Scars

Goldman, Butterwick, Fitzpatrick and Groff

Status: Unknown

Conditions: Atrophic Acne Scar

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05105334

Fraxel/Intracel-2021-8

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

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      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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Nonablative fractional laser alone

Experimental group

Treatment:

Device: Nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone

Nonablative fractional laser alternating with microneedling with radiofrequency

Experimental group

Treatment:

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)