Fractional CO2 Laser Fenestration and Steroid Delivery in HS Lesions

Hidradenitis Suppurativa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05580029
• Other study ID #: APP-22-04651
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: November 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: October 2022
• Source: University of Southern California
• Contact: TIMOTHY J GILLENWATER, MD
• Phone: 323-442-7920
• Email: justin.gillenwater[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 1, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Scar

Intervention

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

Procedure:
• Fractional Ablative CO2 Therapy
1st pass: 30-40 mJ at 5% density. 2nd pass: 120 mJ at 1% density

Drug:
• EMLA 5% cream
2 g/10cm2 Topical 30 minutes before each fractional ablative CO2 session

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

References & Publications (23)

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. — View Citation

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. Review. — View Citation

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 guide — View Citation

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. Review. — View Citation

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;1 — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.S13367 — View Citation

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.166 — View Citation

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. Review. — View Citation

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

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. Epu — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Wang J, Wu J, Xu M, Gao Q, Chen B, Wang F, Song H. Combination therapy of refractory keloid with ultrapulse fractional carbon dioxide (CO(2) ) laser and topical triamcinolone in Asians-long-term prevention of keloid recurrence. Dermatol Ther. 2020 Nov;33( — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endpoint Measure of non-inflammatory nodules	Change from baseline in number of non-inflammatory nodules	After each treatment session (4-6 weeks)
Primary	Endpoint measure of Fibrometer measurements	Change in Fibrometer® measurements	Before and after each treatment session (4-6 weeks)
Primary	Endpoint Measure of Elastimeter	Change in Elastimeter®	Before and after each treatment session (4-6 weeks)
Primary	Endpoint measure of self-reported improvement in HS	Proportion of patients who self-report improvement in HS	After each treatment session (4-6 weeks)
Primary	Endpoint measure of inflammatory nodules	Change from baseline in number of inflammatory nodules	After each treatment session (4-6 weeks)
Primary	Endpoint measure in SkinColorCatch	Change in SkinColorCatch® measurements	Before and after each treatment session (4-6 weeks)
Primary	Endpoint measure of sinus tracts	Change from baseline in number of sinus tracts	After each treatment session (4-6 weeks)
Primary	Endpoint measure of abscesses	Change from baseline in number of abscesses	After each treatment session (4-6 weeks)
Primary	Endpoint measure of pain/itch level	Change from baseline in pain/itch levels Scaled (1-10)	After each treatment session (4-6 weeks)
Primary	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)
Primary	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)
Primary	Endpoint measure of HS-PGA scores	Change from baseline in HS-PGA scores Scaled (0-5)	After each treatment session (4-6 weeks)
Primary	Endpoint measure in patient assessed POSAS score	Change in patient assessed POSAS score	Before and after each treatment session (4-6 weeks)
Primary	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)