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ScarEarly Phase 1NCT05580029

Fractional CO2 Laser Fenestration and Steroid Delivery in HS Lesions

A Early Phase 1 study testing Triamcinolone Topical, Fractional Ablative CO2 Therapy and EMLA 5% cream in people with Scar and Hidradenitis Suppurativa, run by University of Southern California.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Scar, Hidradenitis Suppurativa
What is being tested?
Triamcinolone Topical, Fractional Ablative CO2 Therapy and EMLA 5% cream
How many people
10 participants
Where
No sites listed yet
Study dates
1 Nov 2022to 1 Mar 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

TIMOTHY J GILLENWATER, MD contact

323-442-7920

justin.gillenwater@med.usc.edu

About this study

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.

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.

Read the 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.

Being tested
Triamcinolone Topical, Fractional Ablative CO2 Therapy, EMLA 5% cream
Medical subject headings
Cicatrix, Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triamcinolone TopicalDevice

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

  • Fractional Ablative CO2 TherapyProcedure or surgery

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

  • EMLA 5% creamDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endpoint Measure of non-inflammatory nodules

    Change from baseline in number of non-inflammatory nodules

    Measured: After each treatment session (4-6 weeks)

  2. Endpoint measure of Fibrometer measurements

    Change in Fibrometer® measurements

    Measured: Before and after each treatment session (4-6 weeks)

  3. Endpoint Measure of Elastimeter

    Change in Elastimeter®

    Measured: Before and after each treatment session (4-6 weeks)

  4. Endpoint measure of self-reported improvement in HS

    Proportion of patients who self-report improvement in HS

    Measured: After each treatment session (4-6 weeks)

  5. Endpoint measure of inflammatory nodules

    Change from baseline in number of inflammatory nodules

    Measured: After each treatment session (4-6 weeks)

  6. Endpoint measure in SkinColorCatch

    Change in SkinColorCatch® measurements

    Measured: Before and after each treatment session (4-6 weeks)

  7. Endpoint measure of sinus tracts

    Change from baseline in number of sinus tracts

    Measured: After each treatment session (4-6 weeks)

  8. Endpoint measure of abscesses

    Change from baseline in number of abscesses

    Measured: After each treatment session (4-6 weeks)

  9. Endpoint measure of pain/itch level

    Change from baseline in pain/itch levels Scaled (1-10)

    Measured: After each treatment session (4-6 weeks)

  10. 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)

    Measured: Before and after each treatment session (4-6 weeks)

  11. 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)

    Measured: Before and after each treatment session (4-6 weeks)

  12. Endpoint measure of HS-PGA scores

    Change from baseline in HS-PGA scores Scaled (0-5)

    Measured: After each treatment session (4-6 weeks)

  13. Endpoint measure in patient assessed POSAS score

    Change in patient assessed POSAS score

    Measured: Before and after each treatment session (4-6 weeks)

  14. Endpoint measure of changes in patient global assessment questionnaire scores

    Change from baseline in Patient Global Assessment questionnaire scores

    Measured: After each treatment session (4-6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start1 Nov 2022 (estimated)
  3. Primary completion20 Jan 2023 (estimated)
  4. Study completion1 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Hurley stage I or stage II disease
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05580029
Sponsor's protocol ID
APP-22-04651
Status last verified
Oct 2022
First submitted
30 Sep 2022
Last updated
14 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

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.

    PubMed 19293006

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

    PubMed 22236226

  • 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.

    PubMed 31604104

  • 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.

    PubMed 33890304

  • 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.

    PubMed 26119625

  • 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.

    PubMed 32460374

  • 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.

    PubMed 31688123

  • 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.

    PubMed 30872156

  • 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.

    PubMed 26470622

  • 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.

    PubMed 35160122

  • 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.

    PubMed 12140476

  • 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.

    PubMed 19036028

  • 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.

    PubMed 20039918

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

    PubMed 23904820

  • 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.

    PubMed 19438670

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Triamcinolone Topical, Fractional Ablative CO2 Therapy and EMLA 5% cream in people with Scar and Hidradenitis Suppurativa, run by University of Southern California.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact TIMOTHY J GILLENWATER, MD (323-442-7920, justin.gillenwater@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endpoint Measure of non-inflammatory nodules (time frame: After each treatment session (4-6 weeks)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05580029, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.

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