Fractional CO2 Laser Fenestration and Steroid Delivery in HS Lesions

Open Label Prospective Trial of Fractional Ablative CO 2 Resurfacing With Laser- Facilitated Steroid Delivery in Patients With Mild to Moderate Hidradenitis Suppurativa.

Assess the efficacy of fractional ablative CO2 therapy combined with topical steroids in HS patients with Hurley stage I or stage II disease.

Hidradenitis suppurativa (HS) is a chronic, oftentimes debilitating inflammatory skin condition that presents with painful lesions in intertriginous areas of the body. The reported prevalence of HS in the U.S. is around 1-4%. Medical therapies, which typically consist of topical or systemic antibiotics, hormone- regulating drugs, and immunomodulators, are initially used to control the disease but HS can be recalcitrant to these modalities in the long-term. Optimizing management of mild-moderate HS is crucial to prevent disease progression and improve patients' quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Scar; Hidradenitis Suppurativa
• Intervention / Treatment: Device: Triamcinolone Topical; Procedure: Fractional Ablative CO2 Therapy; Drug: EMLA 5% cream

Detailed Description

This is an open label prospective study aimed at understanding the efficacy of fractional ablative CO 2 laser therapy combined with steroids in HS patients with mild-moderate (Hurley stage I or stage II) disease. Study subjects will be patients with mild-moderate HS. The subjects will undergo a minimum of 3 treatment sessions and up to 5 treatment sessions at 4-6 week intervals. Patients will be informed of the aim of the study and the risks and benefits of the intervention. All questions that the subjects have will be answered and patients will be informed that their participation is completely voluntary. Subjects who agree and consent to participate in the study will partake in the treatment sessions. EMLA™ 5% cream will be applied as a topical anesthetic to the affected area 30 minutes prior to treatment. Fractional ablative CO 2 laser therapy will be performed and the HS lesions that will be treated include: non-inflammatory and inflammatory nodules, sinus tracts, abscesses, and scars. The fractional CO 2 laser treatment will be followed by immediate application of triamcinolone acetonide 40 mg/ml to the treatment area. Patients will be evaluated before the 1st treatment session and before every subsequent treatment session. The last study visit will occur 1 month after the completion of the last treatment session. Before each laser treatment, physicians will perform a complete assessment of Hurley stage and HS-PGA score. The number of non-inflammatory nodules, inflammatory nodules, abscesses, and sinus tracts in the treated area will be counted. Patients will evaluate their pain and itch level and provide their impression on whether their HS has improved, worsened, or stayed the same. Patients will also complete the Patient Global Assessment Item questionnaire. For scars, objective scar assessment will be performed using the Fibrometer ® , Elastimeter ® , and SkinColorCatch ® measurement tools. The Fibrometer ® measures tissue induration and skin stiffness. The Elastimeter ® induces constant skin deformation and returns a measurement of skin elasticity. The SkinColorCatch ® is a colorimeter that allows skin tone to be measured. Measurements of scars will be taken before each treatment session. In addition, the scars will be assessed using the VSS and POSAS scales by the investigators. Patients will also complete a POSAS self- assessment at each treatment session. Pictures of the treatment area will be taken during each visit with permission from the patients to analyze the effects of the treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: TIMOTHY J GILLENWATER, MD; Phone Number: 323-442-7920; Email: justin.gillenwater@med.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older with a diagnosis of HS for at least 6 months
• Subjects who provide informed consent to undergo the procedure
• Patients with mild to moderate HS (Hurley stage I or stage II)
• Must not have been using topical or systemic therapies for 2 weeks prior to starting treatment on the affected area
• The use of antiseptic washes and intralesional steroid injections for acute lesions (rescue therapy) will be allowed

Exclusion Criteria:

• Under the age of 18
• Pregnant women
• Severe HS (Hurley stage III)
• Using topical or systemic medications within the 2 weeks prior to starting therapy
• History of adverse reactions to laser resurfacing or steroids
• Other diseases besides HS which require ongoing systemic therapies
• Active infection within the treatment area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endpoint Measure of non-inflammatory nodules	Change from baseline in number of non-inflammatory nodules	After each treatment session (4-6 weeks)
Endpoint measure of Fibrometer measurements	Change in Fibrometer® measurements	Before and after each treatment session (4-6 weeks)
Endpoint Measure of Elastimeter	Change in Elastimeter®	Before and after each treatment session (4-6 weeks)
Endpoint measure of self-reported improvement in HS	Proportion of patients who self-report improvement in HS	After each treatment session (4-6 weeks)
Endpoint measure of inflammatory nodules	Change from baseline in number of inflammatory nodules	After each treatment session (4-6 weeks)
Endpoint measure in SkinColorCatch	Change in SkinColorCatch® measurements	Before and after each treatment session (4-6 weeks)
Endpoint measure of sinus tracts	Change from baseline in number of sinus tracts	After each treatment session (4-6 weeks)
Endpoint measure of abscesses	Change from baseline in number of abscesses	After each treatment session (4-6 weeks)
Endpoint measure of pain/itch level	Change from baseline in pain/itch levels Scaled (1-10)	After each treatment session (4-6 weeks)
Endpoint measure in investigator assessed VSS score	Change in investigator assessed VSS Vancouver scar scale : Vascularity : normal, pink, red, purple (0-3) Pigmentation : normal, hypopigmentation, hyperpigmentation (0-2) Pliability : normal, supple, yielding, firm, banding, contracture (0-5) Height: normal (flat), 0-2mm, 2-5mm, >5mm (0-3)	Before and after each treatment session (4-6 weeks)
Endpoint Measure in investigator assessed POSAS score	Change in investigator assessed POSAS scores Vascularity (0-10) Pigmentation (0-10) Thickness (0-10) Relief (0-10) Pliability (0-10) Surface area (0-10) Overall opinion (0-10)	Before and after each treatment session (4-6 weeks)
Endpoint measure of HS-PGA scores	Change from baseline in HS-PGA scores Scaled (0-5)	After each treatment session (4-6 weeks)
Endpoint measure in patient assessed POSAS score	Change in patient assessed POSAS score	Before and after each treatment session (4-6 weeks)
Endpoint measure of changes in patient global assessment questionnaire scores	Change from baseline in Patient Global Assessment questionnaire scores	After each treatment session (4-6 weeks)

Collaborators and Investigators

• Sponsor: University of Southern California

Publications and helpful links

General Publications

• Alikhan A, Lynch PJ, Eisen DB. Hidradenitis suppurativa: a comprehensive review. J Am Acad Dermatol. 2009 Apr;60(4):539-61; quiz 562-3. doi: 10.1016/j.jaad.2008.11.911.
• Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available.
• Goldburg SR, Strober BE, Payette MJ. Hidradenitis suppurativa: Epidemiology, clinical presentation, and pathogenesis. J Am Acad Dermatol. 2020 May;82(5):1045-1058. doi: 10.1016/j.jaad.2019.08.090. Epub 2019 Oct 9.
• Preda-Naumescu A, Ahmed HN, Mayo TT, Yusuf N. Hidradenitis suppurativa: pathogenesis, clinical presentation, epidemiology, and comorbid associations. Int J Dermatol. 2021 Nov;60(11):e449-e458. doi: 10.1111/ijd.15579. Epub 2021 Apr 22.
• Ring HC, Riis Mikkelsen P, Miller IM, Jenssen H, Fuursted K, Saunte DM, Jemec GB. The bacteriology of hidradenitis suppurativa: a systematic review. Exp Dermatol. 2015 Oct;24(10):727-31. doi: 10.1111/exd.12793. Epub 2015 Aug 21.
• Nguyen TV, Damiani G, Orenstein LAV, Hamzavi I, Jemec GB. Hidradenitis suppurativa: an update on epidemiology, phenotypes, diagnosis, pathogenesis, comorbidities and quality of life. J Eur Acad Dermatol Venereol. 2021 Jan;35(1):50-61. doi: 10.1111/jdv.16677. Epub 2020 Jul 16.
• Worden A, Yoho DJ, Houin H, Moquin K, Hamzavi I, Saab I, Siddiqui A. Factors Affecting Healing in the Treatment of Hidradenitis Suppurativa. Ann Plast Surg. 2020 Apr;84(4):436-440. doi: 10.1097/SAP.0000000000002105.
• Alikhan A, Sayed C, Alavi A, Alhusayen R, Brassard A, Burkhart C, Crowell K, Eisen DB, Gottlieb AB, Hamzavi I, Hazen PG, Jaleel T, Kimball AB, Kirby J, Lowes MA, Micheletti R, Miller A, Naik HB, Orgill D, Poulin Y. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations: Part I: Diagnosis, evaluation, and the use of complementary and procedural management. J Am Acad Dermatol. 2019 Jul;81(1):76-90. doi: 10.1016/j.jaad.2019.02.067. Epub 2019 Mar 11.
• Hamzavi IH, Griffith JL, Riyaz F, Hessam S, Bechara FG. Laser and light-based treatment options for hidradenitis suppurativa. J Am Acad Dermatol. 2015 Nov;73(5 Suppl 1):S78-81. doi: 10.1016/j.jaad.2015.07.050.
• Das K, Daveluy S, Kroumpouzos G, Agarwal K, Podder I, Farnbach K, Ortega-Loayza AG, Szepietowski JC, Grabbe S, Goldust M. Efficacy and Toxicity of Classical Immunosuppressants, Retinoids and Biologics in Hidradenitis Suppurativa. J Clin Med. 2022 Jan 27;11(3):670. doi: 10.3390/jcm11030670.
• Lapins J, Sartorius K, Emtestam L. Scanner-assisted carbon dioxide laser surgery: a retrospective follow-up study of patients with hidradenitis suppurativa. J Am Acad Dermatol. 2002 Aug;47(2):280-5. doi: 10.1067/mjd.2002.124601.
• Madan V, Hindle E, Hussain W, August PJ. Outcomes of treatment of nine cases of recalcitrant severe hidradenitis suppurativa with carbon dioxide laser. Br J Dermatol. 2008 Dec;159(6):1309-14. doi: 10.1111/j.1365-2133.2008.08932.x.
• Hazen PG, Hazen BP. Hidradenitis suppurativa: successful treatment using carbon dioxide laser excision and marsupialization. Dermatol Surg. 2010 Feb;36(2):208-13. doi: 10.1111/j.1524-4725.2009.01427.x. Epub 2009 Dec 21.
• Ramsdell WM. Fractional carbon dioxide laser resurfacing. Semin Plast Surg. 2012 Aug;26(3):125-30. doi: 10.1055/s-0032-1329414.
• Tierney E, Mahmoud BH, Hexsel C, Ozog D, Hamzavi I. Randomized control trial for the treatment of hidradenitis suppurativa with a neodymium-doped yttrium aluminium garnet laser. Dermatol Surg. 2009 Aug;35(8):1188-98. doi: 10.1111/j.1524-4725.2009.01214.x. Epub 2009 May 12.
• Riis PT, Boer J, Prens EP, Saunte DM, Deckers IE, Emtestam L, Sartorius K, Jemec GB. Intralesional triamcinolone for flares of hidradenitis suppurativa (HS): A case series. J Am Acad Dermatol. 2016 Dec;75(6):1151-1155. doi: 10.1016/j.jaad.2016.06.049. Epub 2016 Sep 28.
• Wang J, Wu J, Xu M, Gao Q, Chen B, Wang F, Song H. Combination therapy of refractory keloid with ultrapulse fractional carbon dioxide (CO2 ) laser and topical triamcinolone in Asians-long-term prevention of keloid recurrence. Dermatol Ther. 2020 Nov;33(6):e14359. doi: 10.1111/dth.14359. Epub 2020 Oct 12.
• Waibel JS, Wulkan AJ, Shumaker PR. Treatment of hypertrophic scars using laser and laser assisted corticosteroid delivery. Lasers Surg Med. 2013 Mar;45(3):135-40. doi: 10.1002/lsm.22120. Epub 2013 Mar 4.
• Alakad R, Nassar A, Atef H, Eldeeb F. Fractional CO2 Laser-Assisted Delivery Versus Intralesional Injection of Methotrexate in Psoriatic Nails. Dermatol Surg. 2022 May 1;48(5):539-544. doi: 10.1097/DSS.0000000000003418. Epub 2022 Mar 24.
• Majid I, Jeelani S, Imran S. Fractional Carbon Dioxide Laser in Combination with Topical Corticosteroid Application in Resistant Alopecia Areata: A Case Series. J Cutan Aesthet Surg. 2018 Oct-Dec;11(4):217-221. doi: 10.4103/JCAS.JCAS_96_18.
• Haedersdal M, Sakamoto FH, Farinelli WA, Doukas AG, Tam J, Anderson RR. Fractional CO(2) laser-assisted drug delivery. Lasers Surg Med. 2010 Feb;42(2):113-22. doi: 10.1002/lsm.20860.
• Morelli Coppola M, Salzillo R, Segreto F, Persichetti P. Triamcinolone acetonide intralesional injection for the treatment of keloid scars: patient selection and perspectives. Clin Cosmet Investig Dermatol. 2018 Jul 24;11:387-396. doi: 10.2147/CCID.S133672. eCollection 2018.
• Coondoo A, Phiske M, Verma S, Lahiri K. Side-effects of topical steroids: A long overdue revisit. Indian Dermatol Online J. 2014 Oct;5(4):416-25. doi: 10.4103/2229-5178.142483.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): January 20, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone
• Other Study ID Numbers: APP-22-04651

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes