An Early Phase 1 interventional study of Triamcinolone Topical and Fractional Ablative CO2 Therapy in Scar and Hidradenitis Suppurativa, sponsored by University of Southern California. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-14.
Sponsored by University of Southern California · Early Phase 1, Interventional, and Treatment
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.
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.
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
This study's planned enrollment of 10 is below the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
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Exclusion Criteria:
The treatments will consist of fractional ablative CO2 laser therapies followed by topical application of triamcinolone dosed at 40 mg/ml.
1st pass: 30-40 mJ at 5% density. 2nd pass: 120 mJ at 1% density
2 g/10cm2 Topical 30 minutes before each fractional ablative CO2 session
Endpoint Measure of non-inflammatory nodules
Change from baseline in number of non-inflammatory nodules
Time frame: After each treatment session (4-6 weeks)
Endpoint measure of Fibrometer measurements
Change in Fibrometer® measurements
Time frame: Before and after each treatment session (4-6 weeks)
Endpoint Measure of Elastimeter
Change in Elastimeter®
Time frame: 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
Time frame: After each treatment session (4-6 weeks)
Endpoint measure of inflammatory nodules
Change from baseline in number of inflammatory nodules
Time frame: After each treatment session (4-6 weeks)
Endpoint measure in SkinColorCatch
Change in SkinColorCatch® measurements
Time frame: Before and after each treatment session (4-6 weeks)
Endpoint measure of sinus tracts
Change from baseline in number of sinus tracts
Time frame: After each treatment session (4-6 weeks)
Endpoint measure of abscesses
Change from baseline in number of abscesses
Time frame: After each treatment session (4-6 weeks)
Endpoint measure of pain/itch level
Change from baseline in pain/itch levels Scaled (1-10)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: After each treatment session (4-6 weeks)
Endpoint measure in patient assessed POSAS score
Change in patient assessed POSAS score
Time frame: 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
Time frame: After each treatment session (4-6 weeks)
No study locations are listed for this record.
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University of Southern California