Combined Therapy for Acne Scars

NCT05105334 | Unknown FDA Device

• 1 other identifier: Fraxel/Intracel-2021-8
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Atrophic Acne Scar

Keywords

Acne; Acne scar; Face; Microneedling; Intracel; Fraxel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Subject comfort level

  To be done right after treatments

• Subjective change

  3 months after final treatment

• Subject satisfaction

  3 months after final treatment

• Adverse events

  3 months after final treatment

Study Arms (2)

Nonablative fractional laser alone

EXPERIMENTAL

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

Nonablative fractional laser alternating with microneedling with radiofrequency

EXPERIMENTAL

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)

Interventions

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

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.

Nonablative fractional laser alone; Nonablative fractional laser alternating with microneedling with radiofrequency

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

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.

Nonablative fractional laser alternating with microneedling with radiofrequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
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• Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
• Intrauterine coil

You may not qualify if:

• 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

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead

Related Publications (20)

• 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.

  PMID: 28300850 BACKGROUND

• 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.

  PMID: 30856634 BACKGROUND

• 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.

  PMID: 15216537 BACKGROUND

• 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.

  PMID: 17338686 BACKGROUND

• Hu S, Chen MC, Lee MC, Yang LC, Keoprasom N. Fractional resurfacing for the treatment of atrophic facial acne scars in asian skin. Dermatol Surg. 2009 May;35(5):826-32. doi: 10.1111/j.1524-4725.2009.01139.x. Epub 2009 Apr 6.

  PMID: 19397671 BACKGROUND

• Hedelund L, Moreau KE, Beyer DM, Nymann P, Haedersdal M. Fractional nonablative 1,540-nm laser resurfacing of atrophic acne scars. A randomized controlled trial with blinded response evaluation. Lasers Med Sci. 2010 Sep;25(5):749-54. doi: 10.1007/s10103-010-0801-1. Epub 2010 Jun 17.

  PMID: 20556471 BACKGROUND

• Bencini PL, Tourlaki A, Galimberti M, Longo C, Pellacani G, De Giorgi V, Guerriero G. Nonablative fractional photothermolysis for acne scars: clinical and in vivo microscopic documentation of treatment efficacy. Dermatol Ther. 2012 Sep-Oct;25(5):463-7. doi: 10.1111/j.1529-8019.2012.01478.x.

  PMID: 23046026 BACKGROUND

• Al-Dhalimi M, Jaber A. Treatment of atrophic facial acne scars with fractional Er:Yag laser. J Cosmet Laser Ther. 2015;17(4):184-8. doi: 10.3109/14764172.2015.1007067. Epub 2015 Feb 13.

  PMID: 25588037 BACKGROUND

• Alexis AF, Coley MK, Nijhawan RI, Luke JD, Shah SK, Argobi YA, Nodzenski M, Veledar E, Alam M. Nonablative Fractional Laser Resurfacing for Acne Scarring in Patients With Fitzpatrick Skin Phototypes IV-VI. Dermatol Surg. 2016 Mar;42(3):392-402. doi: 10.1097/DSS.0000000000000640.

  PMID: 26945321 BACKGROUND

• Gold MH, Biron JA. Treatment of acne scars by fractional bipolar radiofrequency energy. J Cosmet Laser Ther. 2012 Aug;14(4):172-8. doi: 10.3109/14764172.2012.687824. Epub 2012 May 30.

  PMID: 22548644 BACKGROUND

• Cho SI, Chung BY, Choi MG, Baek JH, Cho HJ, Park CW, Lee CH, Kim HO. Evaluation of the clinical efficacy of fractional radiofrequency microneedle treatment in acne scars and large facial pores. Dermatol Surg. 2012 Jul;38(7 Pt 1):1017-24. doi: 10.1111/j.1524-4725.2012.02402.x. Epub 2012 Apr 9.

  PMID: 22487513 BACKGROUND

• Chandrashekar BS, Sriram R, Mysore R, Bhaskar S, Shetty A. Evaluation of microneedling fractional radiofrequency device for treatment of acne scars. J Cutan Aesthet Surg. 2014 Apr;7(2):93-7. doi: 10.4103/0974-2077.138328.

  PMID: 25136209 BACKGROUND

• 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.

  PMID: 25158223 BACKGROUND

• Kaminaka C, Uede M, Matsunaka H, Furukawa F, Yamamoto Y. Clinical studies of the treatment of facial atrophic acne scars and acne with a bipolar fractional radiofrequency system. J Dermatol. 2015 Jun;42(6):580-7. doi: 10.1111/1346-8138.12864. Epub 2015 Apr 9.

  PMID: 25855397 BACKGROUND

• Bulbul Baskan E, Akin Belli A. Evaluation of the efficacy of microneedle fractional radiofrequency in Turkish patients with atrophic facial acne scars. J Cosmet Dermatol. 2019 Oct;18(5):1317-1321. doi: 10.1111/jocd.12812. Epub 2018 Nov 11.

  PMID: 30417509 BACKGROUND

• Jacob CI, Dover JS, Kaminer MS. Acne scarring: a classification system and review of treatment options. J Am Acad Dermatol. 2001 Jul;45(1):109-17. doi: 10.1067/mjd.2001.113451.

  PMID: 11423843 BACKGROUND

• Zaleski-Larsen LA, Fabi SG, McGraw T, Taylor M. Acne Scar Treatment: A Multimodality Approach Tailored to Scar Type. Dermatol Surg. 2016 May;42 Suppl 2:S139-49. doi: 10.1097/DSS.0000000000000746.

  PMID: 27128240 BACKGROUND

• Rongsaard N, Rummaneethorn P. Comparison of a fractional bipolar radiofrequency device and a fractional erbium-doped glass 1,550-nm device for the treatment of atrophic acne scars: a randomized split-face clinical study. Dermatol Surg. 2014 Jan;40(1):14-21. doi: 10.1111/dsu.12372. Epub 2013 Nov 25.

  PMID: 24267397 BACKGROUND

• Chae WS, Seong JY, Jung HN, Kong SH, Kim MH, Suh HS, Choi YS. Comparative study on efficacy and safety of 1550 nm Er:Glass fractional laser and fractional radiofrequency microneedle device for facial atrophic acne scar. J Cosmet Dermatol. 2015 Jun;14(2):100-6. doi: 10.1111/jocd.12139. Epub 2015 Mar 23.

  PMID: 25810322 BACKGROUND

• Kwon HH, Park HY, Choi SC, Bae Y, Kang C, Jung JY, Park GH. Combined Fractional Treatment of Acne Scars Involving Non-ablative 1,550-nm Erbium-glass Laser and Micro-needling Radiofrequency: A 16-week Prospective, Randomized Split-face Study. Acta Derm Venereol. 2017 Aug 31;97(8):947-951. doi: 10.2340/00015555-2701.

  PMID: 28512669 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris; Facies

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Nina Semsarzadeh, MD

  Cosmetic Laser Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherif Mikhail, MD

CONTACT

8586571004; research@clderm.com

Andrea Pacheco

CONTACT

8586571004; research@clderm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, split-face, evaluator-blinded study

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: November 8, 2021
• Primary Completion: May 8, 2022
• Study Completion: July 8, 2022
• Last Updated: November 10, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share