L73.2
Conditions
Interventions
Group 1: Therapy with medicinal guideline therapy and additional 8 therapy sessions with LAight® every 14 days (week 0 - week 16).
After cross-over another 8 therapy sessions with LAight® every 14 day
Sponsors
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18; 2. Disease severity: Hurley stage 1 or Hurley stage 2; 3. At least one affected area typical for HS (axillary, inguinal, gluteal, mammary); 4. At least 3 inflammatory nodules or abscesses; 5. The mental ability to understand the patient information and follow the study procedure.
Exclusion criteria
Exclusion criteria: 1. Disease severity: Hurley stage 3; 2. Medical guideline therapy not possible; 3. Other disease that leads to systemic Inflammation; 4. Therapy with antibiotics or retinoids within the last 2 weeks; 5. Pre-treatment with the LAight®-therapy; 6. Contraindications LAight®-therapy; a) Pregnancy; b) Epilepsy; c) Electronically controlled implants (e.g. Pacemaker, cardiac stimulator) d) Extreme photosensitivity (also of a medicinal nature); e) Melanoma or skin Cancer; f) Contagious skin diseases; g) Tattoos, piercing, permanent make-up or branding on the body parts to be treated; h) Injections (within the last 6 months) on the body parts to be treated (e.g. Botox or Hyaluron); i) Implants at a radius of 10 cm to the body parts to be treated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute difference in International Hidradenitis suppurativa score (IHS4) after 16 weeks and the baseline (= last measurement of a patient before the intervention, evaluated by a dermatologist). | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute difference in Dermatology Life Quality Index (DLQI) after 16 weeks and baseline (= last measurement of a patient before the intervention, evaluated by a questionnaire). Percentage of patients having a clinical response according to Hidradenitis Suppurativa Clinical Response (HiSCR), nach 16 Wochen compared to baseline (= last measurement of a patient before the intervention, evaluated by a dermatologist). Absolute difference in Hospital Anxiety and Depression Scale (SAHS) after 16 weeks and baseline (= last measurement of a patient before the intervention, evaluated by a questionnaire). Absolute difference in SAHS after 16 weeks and the baseline (= last measurement of a patient before the intervention, evaluated by a dermatologist and questionaire). For patients with pain score (NRS) of = 3 at baseline (= last measurement of a patient before the intervention, evaluated by a questionnaire), the percentage of patients with a reduction of =30% and =1 unit in pain score. | — |
Countries
Germany, Poland
Contacts
Public ContactMichael Schultheis
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Outcome results
None listed