LAight (R) 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

Schultheis, Michael, Staubach, Petra, Nikolakis, Georgios, Grabbe, Stephan, Ruckes, Christian, von Stebut, Esther, Kirschner, Uwe, Matusiak, Lukasz and Szepietowski, Jacek C. . LAight (R) 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. Dermatology. BASEL: KARGER. ISSN 1421-9832

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DOI:10.1159/000518540

Abstract

Background: 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 (R) therapy - a combination of intense pulsed light and radiofrequency - as an adjunct treatment to first-line therapies in Hurley stage I and II HS. Methods: 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 (R) 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 (R) therapy for an additional 16 weeks (8 sessions). The primary efficacy endpoint was the change in International Hidradenitis Suppurativa Score System (increment IHS4) at week 16 to baseline. Secondary endpoints were DLQI, HiSCR, Pain-NRS, and HADS. Results: 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 increment IHS4 of the group treated with the combination of LAight (R) therapy and topical clindamycin 1% solution was -7.2 +/- 6.7 (-60.0%), which was significantly higher in magnitude than the increment IHS4 in the group treated with clindamycin 1% solution alone (-1.8 +/- 5.6, -17.8%, p < 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. Conclusion: The results of the primary endpoint analysis of period A of the RELIEVE study show that the combined therapy with LAight (R) 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 (R) therapy as long-term monotherapy (results from period B), will be analyzed in a consecutive paper. (c) 2021 S. Karger AG, Basel

Item Type:

Journal Article

Creators:

Creators	Email	ORCID	ORCID Put Code
Schultheis, Michael	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Staubach, Petra	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Nikolakis, Georgios	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Grabbe, Stephan	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Ruckes, Christian	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
von Stebut, Esther	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Kirschner, Uwe	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Matusiak, Lukasz	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED
Szepietowski, Jacek C.	UNSPECIFIED	UNSPECIFIED	UNSPECIFIED