Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05580029
Study type Interventional
Source University of Southern California
Contact TIMOTHY J GILLENWATER, MD
Phone 323-442-7920
Email justin.gillenwater@med.usc.edu
Status Not yet recruiting
Phase Early Phase 1
Start date November 1, 2022
Completion date March 1, 2023

See also
  Status Clinical Trial Phase
Completed NCT02904902 - Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa Phase 3
Completed NCT03628924 - A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 2
Not yet recruiting NCT05531747 - Replicative Stress in Hair Follicle Stem Cells and Pathogeny of Hidradenitis Suppurativa N/A
Recruiting NCT06028230 - A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Phase 2
Completed NCT03275870 - Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa Phase 1/Phase 2
Completed NCT03248531 - A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa. Phase 2
Withdrawn NCT04100083 - Spironolactone for Hidradenitis Suppurativa Phase 4
Completed NCT00329823 - Etanercept in Hidradenitis Suppurativa Phase 2
Recruiting NCT05710393 - Hidradenitis - an Analysis of Genetic Traits and Linkages in Families
Completed NCT04019041 - A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa Phase 2
Completed NCT05286567 - A Double-blind Placebo-controlled Randomized Trial Evaluating the Efficacy and Safety of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Supppurativa. Phase 1
Withdrawn NCT03929835 - Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa Phase 2
Terminated NCT04325607 - Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa N/A
Terminated NCT03238469 - Microwave Ablation in Mild Axillary Hidradenitis Suppurativa N/A
Completed NCT04449354 - HidraWear AX HS Study N/A
Recruiting NCT06123429 - Mindfulness in Hidradenitis Suppurativa N/A
Recruiting NCT05934825 - Clinical Trial to Evaluate Safety and Efficiency of Mesenchymal Stem Cell in Patients With Hidradenitis Suppurativa Phase 1/Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT06046729 - A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Phase 2
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2