Combined Therapy for Acne Scars

November 2, 2021 updated by: Goldman, Butterwick, Fitzpatrick and Groff

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject comfort level
Time Frame: 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.
To be done right after treatments
Subjective change
Time Frame: 3 months after final treatment
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
Time Frame: 3 months after final treatment
Subjects will rate satisfaction on a 1-5 scale.
3 months after final treatment
Adverse events
Time Frame: 3 months after final treatment
To be recorded by treating physician after treatment.
3 months after final treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goldman, Butterwick, Fitzpatrick and Groff

Investigators

  • Principal Investigator: Nina Semsarzadeh, MD, Cosmetic Laser Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 8, 2021

Primary Completion (Anticipated)

May 8, 2022

Study Completion (Anticipated)

July 8, 2022

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

November 10, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fraxel/Intracel-2021-8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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