Combined Therapy for Acne Scars

Sponsor

Goldman, Butterwick, Fitzpatrick and Groff (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05105334

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atrophic Acne Scar	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)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomized, split-face, evaluator-blinded studyProspective, randomized, split-face, evaluator-blinded study

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 8, 2021

Anticipated Primary Completion Date :

May 8, 2022

Anticipated Study Completion Date :

Jul 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nonablative fractional laser alone	Device: Nonablative 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.
Experimental: Nonablative fractional laser alternating with microneedling with radiofrequency	Device: Nonablative 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. Device: Nonablative 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.

Arm

Intervention/Treatment

Experimental: Nonablative fractional laser alone

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

Experimental: Nonablative fractional laser alternating with microneedling with radiofrequency

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)

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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