Comparing the effectiveness of the treatment of hidradenitis suppurativa (acne inversa) with the combination of LAight® therapy with guideline-based drug therapy in relation to guideline-based drug therapy alone

Not Applicable

• Conditions: L73.2; Hidradenitis suppurativa

• Registration Number: DRKS00017543
• Lead Sponsor: niversitätsmedizin der Johannes Gutenberg-Universität Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-25
• Study Completion: 2021-03-10
• Results First Posted: 2021-09-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 88

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).<br><br>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).<br><br>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).<br><br>Absolute difference in SAHS after 16 weeks and the baseline (= last measurement of a patient before the intervention, evaluated by a dermatologist and questionaire).<br><br>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.