Fractional CO2 Laser Fenestration and Steroid Delivery in HS Lesions

NCT05580029 | Unknown Early Phase 1 FDA Drug FDA Device

• 1 other identifier: APP-22-04651
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Scar; Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (14)

• 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)

Interventions

Triamcinolone Topical DEVICE

The treatments will consist of fractional ablative CO2 laser therapies followed by topical application of triamcinolone dosed at 40 mg/ml.

Fractional Ablative CO2 Therapy PROCEDURE

1st pass: 30-40 mJ at 5% density. 2nd pass: 120 mJ at 1% density

EMLA 5% cream DRUG

2 g/10cm2 Topical 30 minutes before each fractional ablative CO2 session

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Related Publications (23)

• 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.

  PMID: 19293006 RESULT

• Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available.

  PMID: 22236226 RESULT

• 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.

  PMID: 31604104 RESULT

• 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.

  PMID: 33890304 RESULT

• 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.

  PMID: 26119625 RESULT

• 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.

  PMID: 32460374 RESULT

• 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.

  PMID: 31688123 RESULT

• 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.

  PMID: 30872156 RESULT

• 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.

  PMID: 26470622 RESULT

• 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.

  PMID: 35160122 RESULT

• 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.

  PMID: 12140476 RESULT

• 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.

  PMID: 19036028 RESULT

• 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.

  PMID: 20039918 RESULT

• Ramsdell WM. Fractional carbon dioxide laser resurfacing. Semin Plast Surg. 2012 Aug;26(3):125-30. doi: 10.1055/s-0032-1329414.

  PMID: 23904820 RESULT

• 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.

  PMID: 19438670 RESULT

• 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.

  PMID: 27692735 RESULT

• 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.

  PMID: 33002270 RESULT

• 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.

  PMID: 23460557 RESULT

• 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.

  PMID: 35333217 RESULT

• 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.

  PMID: 30886476 RESULT

• 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.

  PMID: 20166154 RESULT

• 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.

  PMID: 30087573 RESULT

• 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.

  PMID: 25396122 RESULT

MeSH Terms

Conditions

Cicatrix; Hidradenitis Suppurativa

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Central Study Contacts

TIMOTHY J GILLENWATER, MD

CONTACT

323-442-7920; justin.gillenwater@med.usc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Hurley stage I or stage II disease

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 14, 2022
• Study Start: November 1, 2022
• Primary Completion: January 20, 2023
• Study Completion: March 1, 2023
• Last Updated: October 14, 2022

Record last verified: 2022-10