Clinical trial NCT05762484: Efficacy of Laser Hair Removal Therapy in HS
Official title: The Efficacy of Laser Hair Removal Therapy in Patients With Mild to Moderate HS, a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hidradenitis Suppurativa, Acne Inversa
Keywords: laser hair removal therapy
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT with intervention and control group
Primary purpose: TREATMENT

Brief summary: Hidradenitis suppurativa (HS) is a chronic, recurrent and debilitating inflammatory skin disorder, characterized by painful inflamed nodules, abscesses and tunnels in the skin folds such as the axilla, inguinal region and gluteal area. The primary event in HS is occlusion of the hair follicle. HS is a notoriously difficult to treat disease, because treatment options are limited and evidence based treatments are scarce. Prevention of diseases is an important topic in medicine. However, current clinical trials in HS are focusing on anti-inflammatory drugs in patients with severe HS, whereas prevention and treatment of patients with more common mild HS is neglected. Laser hair removal therapy is a non-invasive procedure with minimal treatment discomfort for patients. Previous limited studies have suggested positive results in favor of laser hair removal therapy in HS. We therefore hypothesize that hair depilation using laser hair removal therapy may prevent the formation of new lesions and flares of the disease. The objective is to assess the efficacy of laser hair removal therapy in patients with mild to moderate HS.


Eligibility criteria: Inclusion Criteria:

* IHS4 mild to moderate, without tunnels in the axillae.
* HS activity in at least one axilla.
* Age 18 years and over.

Exclusion Criteria:

* If the patient is not able or willing to provide informed consent.
* If the patient is allergic to clindamycin lotion.
* If the patient uses systemic therapy for HS such as antibiotics or biologicals.
* If a patient is pregnant.

Primary outcomes:
measure: Difference in IHS4 over time, measured between month 7 to month 12
timeFrame: between month 7 to 12
Secondary outcomes:
measure: Cumulative IHS4 over month 7 to month 12 between the two groups
timeFrame: month 7 to 12
measure: Change in skin related pain of the axillae, on a numerical rating scale (NRS), between baseline and month 12, and between groups.
timeFrame: every month for 12 months
measure: Change in skin related itch of the axillae, on a NRS, between baseline and month 12, and between groups.
timeFrame: every month for 12 months
measure: Difference in number of self-reported flares (number of flares reported by the patients in the last 4 weeks), between the two groups during this study
timeFrame: every month for 12
measure: Difference and change in quality of life measured with the Dermatologic Life Quality Index (DLQI) between baseline and month 12 and between groups.
timeFrame: every month for 12 months
measure: Difference and change in quality of life measured with the Hidradenitis Suppurativa Quality of Life score (HiSQOL), between baseline and month 12 and between groups.
timeFrame: every month for 12 months
measure: Difference in patients satisfaction score at month 12 between groups.
timeFrame: every month for 12 months
measure: Cumulative IHS4 over month 7 to 12, correlated to hair loss after six months.
timeFrame: every month for 12 months
measure: Cumulative IHS4 calculated over a time period of 3, 9 and 12 months between groups.
timeFrame: every month for 12 months
measure: Difference in pustule and papule count during visits over month 1 to 12 between groups.
timeFrame: every month for 12 months
measure: Difference in (cumulative) abscess en nodule count over month 1 to 12 between groups.
timeFrame: every month for 12 months
measure: Difference in number of times escape medication has been used over month 1 to 12 between groups.
timeFrame: every month for 12months
measure: Difference of average duration of a flare, reported by the patient, over month 1 to 12 between groups.
timeFrame: every month for 12 months
measure: The difference in IHS4 and HS-PGA, measured every visit.
timeFrame: every month for 12 months
measure: Amount of clindamycin lotion use for both groups.
timeFrame: every month for 12 months
measure: Difference in number of adverse events between groups.
timeFrame: every month for 12 months
measure: Incidence and severity of all adverse events (according to medDRA) will be analysed throughout the study.
timeFrame: every month for 12 months
measure: Histopathological: diameter hair shaft in axillary skin before and after treatment.
timeFrame: Measured at baseline (month 1), after laser hair removal therapy (month 7) and six months after laser hair removal therapy (month 12), for the intervention group
measure: Histopathological: plugging of the hair follicle in the skin before and after treatment
timeFrame: Measured at baseline (month 1), after laser hair removal therapy (month 7) and six months after laser hair removal therapy (month 12), for the intervention group
measure: Histopathological: immunohistochemistry in the skin before and after treatment
timeFrame: Measured at baseline (month 1), after laser hair removal therapy (month 7) and six months after laser hair removal therapy (month 12), for the intervention group
measure: Histopathological: AMP expression in the skin before and after treatment
timeFrame: Measured at baseline (month 1), after laser hair removal therapy (month 7) and six months after laser hair removal therapy (month 12), for the intervention group
Other outcomes:
Locations:
Study officials:
affiliation: Erasmus Medical Center
name: Hessel van der Zee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: