Clinical trial NCT05105334: Combined Therapy for Acne Scars
Official title: Combined Treatment With Nonablative Fractional Laser and Radiofrequency Microneedling for the Treatment of Acne Scars: A Prospective, Randomized, Split-Face Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrophic Acne Scar
Keywords: Acne
Acne scar
Face
Microneedling
Intracel
Fraxel
Lead sponsor: Goldman, Butterwick, Fitzpatrick and Groff
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, split-face, evaluator-blinded study
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in atrophic acne scar
timeFrame: 3 months after final treatment
Secondary outcomes:
measure: Subject comfort level
timeFrame: To be done right after treatments
measure: Subjective change
timeFrame: 3 months after final treatment
measure: Subject satisfaction
timeFrame: 3 months after final treatment
measure: Adverse events
timeFrame: 3 months after final treatment
Other outcomes:
Locations:
Study officials:
affiliation: Cosmetic Laser Dermatology
name: Nina Semsarzadeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tan J, Kang S, Leyden J. Prevalence and Risk Factors of Acne Scarring Among Patients Consulting Dermatologists in the USA. J Drugs Dermatol. 2017 Feb 1;16(2):97-102.
citation: Boen M, Jacob C. A Review and Update of Treatment Options Using the Acne Scar Classification System. Dermatol Surg. 2019 Mar;45(3):411-422. doi: 10.1097/DSS.0000000000001765.
citation: Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
citation: Alster TS, Tanzi EL, Lazarus M. The use of fractional laser photothermolysis for the treatment of atrophic scars. Dermatol Surg. 2007 Mar;33(3):295-9. doi: 10.1111/j.1524-4725.2007.33059.x.
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citation: Vejjabhinanta V, Wanitphakdeedecha R, Limtanyakul P, Manuskiatti W. The efficacy in treatment of facial atrophic acne scars in Asians with a fractional radiofrequency microneedle system. J Eur Acad Dermatol Venereol. 2014 Sep;28(9):1219-25. doi: 10.1111/jdv.12267. Epub 2013 Sep 24.
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