LAight® Therapy Significantly Enhances Treatment Efficacy of 16 Weeks of Topical Clindamycin Solution in Hurley I and II Hidradenitis Suppurativa: Results from Period A of RELIEVE, a Multicenter Randomized, Controlled Trial

Abstract

<b><i>Background:</i></b> Hidradenitis suppurativa (HS) is a chronic, inflammatory, burdensome skin disease where medical first-line treatment is still limited to long-term, topical and/or systemic antibiotics. The RELIEVE study aimed at evaluating the efficacy of LAight® therapy – a combination of intense pulsed light and radiofrequency – as an adjunct treatment to first-line therapies in Hurley stage I and II HS. <b><i>Methods:</i></b> The RELIEVE study was performed as a two-period multicenter randomized controlled trial with blinded assessment. For period A from week 0 to week 16, the 88 participating subjects were randomized into either an intervention group (IG) or a control group (CG). The IG received topical clindamycin 1% solution combined with 8 additional bi-weekly treatments with LAight® therapy. The CG was treated with topical clindamycin 1% solution only. After 16 weeks, patients entered open-label period B and both groups were treated exclusively with LAight® therapy for an additional 16 weeks (8 sessions). The primary efficacy endpoint was the change in International Hidradenitis Suppurativa Score System (∆IHS4) at week 16 to baseline. Secondary endpoints were DLQI, HiSCR, Pain-NRS, and HADS. <b><i>Results:</i></b> In total, from the 88 patients enrolled in RELIEVE, 81 patients were included in the endpoint analysis after period A. After 16 weeks of treatment, the ∆IHS4 of the group treated with the combination of LAight® therapy and topical clindamycin 1% solution was −7.2 ± 6.7 (−60.0%), which was significantly higher in magnitude than the ∆IHS4 in the group treated with clindamycin 1% solution alone (−1.8 ± 5.6, −17.8%, <i>p</i> < 0.001). Secondary endpoints, including other clinical scores as well as patient-reported outcomes, confirmed that the efficacy of the combined treatment was superior to monotherapy. <b><i>Conclusion:</i></b> The results of the primary endpoint analysis of period A of the RELIEVE study show that the combined therapy with LAight® and topical clindamycin 1% solution, resulted in a significantly higher decrease in disease severity and an improvement of quality of life in comparison to topical clindamycin 1% solution monotherapy. Treatment was well tolerated, and side effects were all mild and transitory. These data speak for the implementation of the combined treatment as a first-line therapy in Hurley stage I and II HS. LAight® therapy as long-term monotherapy (results from period B), will be analyzed in a consecutive paper.

Trends in Hidradenitis Suppurativa Disease Severity and Quality of Life Outcome Measures: Scoping Review

“…A total of 171 nonduplicated reports were identified; 60 articles underwent a full-text review, and a total of 41 studies [ 10 - 50 ] were included in this review ( Figure 1 ). For each included RCT, the level of evidence was rated according to the evidence levels established by the Oxford Centre for Evidence-Based Medicine [ 51 ].…”

LAight® Therapy Is an Effective Treatment Option to Maintain Long-Term Remission of Hurley I and II Hidradenitis Suppurativa: Results from Period B of RELIEVE, a Multicenter Randomized, Controlled Trial

“…The results of period A of the RELIEVE study show that the combination of LAight® therapy with topical clindamycin 1% solution for 16 weeks is an effective and safe approach to treat Hurley stage I and II HS. The combination was clearly dominant over monotherapy with topical clindamycin 1% solution alone [ 11 ]. Period B of the presented RELIEVE study evaluated whether LAight® treatment as monotherapy has the potential to maintain, or even improve, therapeutic effects beyond treatment week 16 after initially failed therapy, i.e., nonresponders, with topical clindamycin 1% solution only (TC/L) or combined LAight® therapy and clindamycin therapy TC + L/L.…”

“…This paper describes results of period B of the RELIEVE study. Findings of period A investigating the efficacy of LAight® treatment combined with first-line medical therapies in Hurley I and II are presented in a precedent paper [ 11 ].…”

“…It utilizes a combination of radiofrequency (RF) and intense pulsed light (IPL). The results of the primary endpoint analysis of period A of the RELIEVE study showed that a combined therapy with LAight® and topical clindamycin 1% solution reduced disease severity and improved quality of life significantly more effectively than clindamycin alone [ 11 ].…”

Hidradenitis Suppurativa Is Associated with Severe Sexual Impairment

“…The aim is to combine data from the everyday care of a large number of HS patients with additional digital surveys. All HS-diagnosed patients who have agreed to have the documentation of their LAight ® therapy (physical treatment option in Germany performed in outpatient offices) stored in the LENICURA software were invited to participate in EpiCAi [30,31]. The invitation to the study was sent by mail to the mail address provided by patients for research purposes, and flyers were displayed at the treatment sites of the LAight ® therapy.…”