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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Using the Nd:YAG laser (cynergy), hair of the axillae will be removed.
Clindamycin 1% lotion if needed
Difference in IHS4 over time, measured between month 7 to month 12
The IHS4 will be assessed monthly.
Time frame: between month 7 to 12
Cumulative IHS4 over month 7 to month 12 between the two groups
IHS4 will be calculated on a monthly bases. IHS4 will be added up per visit which makes it a cumulative outcome
Time frame: month 7 to 12
Change in skin related pain of the axillae, on a numerical rating scale (NRS), between baseline and month 12, and between groups.
NRS pain will be assessed
Time frame: every month for 12 months
Change in skin related itch of the axillae, on a NRS, between baseline and month 12, and between groups.
NRS itch will be assessed
Time frame: every month for 12 months
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
Number of self reported flares will be assessed
Time frame: every month for 12
Difference and change in quality of life measured with the Dermatologic Life Quality Index (DLQI) between baseline and month 12 and between groups.
PROM will be assessed
Time frame: every month for 12 months
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.
PROM will be assessed
Time frame: every month for 12 months
Difference in patients satisfaction score at month 12 between groups.
patients satisfaction will be assessed
Time frame: every month for 12 months
Cumulative IHS4 over month 7 to 12, correlated to hair loss after six months.
the amount of hair loss will be assessed and correlated to the cumulative IHS4
Time frame: every month for 12 months
Cumulative IHS4 calculated over a time period of 3, 9 and 12 months between groups.
The cumulative IHS4 will be assessed after 3, 9 and 12 months
Time frame: every month for 12 months
Difference in pustule and papule count during visits over month 1 to 12 between groups.
the number of papules and pustules will be assessed
Time frame: every month for 12 months
Difference in (cumulative) abscess en nodule count over month 1 to 12 between groups.
number of abscesses and nodules will be assessed
Time frame: every month for 12 months
Difference in number of times escape medication has been used over month 1 to 12 between groups.
Number of escape medication will be assessed
Time frame: every month for 12months
Difference of average duration of a flare, reported by the patient, over month 1 to 12 between groups.
Duration of a flare will be assessed
Time frame: every month for 12 months
The difference in IHS4 and HS-PGA, measured every visit.
The IHS4 and HS-PGA will be assessed
Time frame: every month for 12 months
Amount of clindamycin lotion use for both groups.
clindamycin 1% lotion will be weighted every visit
Time frame: every month for 12 months
Difference in number of adverse events between groups.
safety will be assessed using adverse events
Time frame: every month for 12 months
Incidence and severity of all adverse events (according to medDRA) will be analysed throughout the study.
safety will be assessed using adverse events
Time frame: every month for 12 months
Histopathological: diameter hair shaft in axillary skin before and after treatment.
Biopsies will be taken for histopathological research
Time frame: 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
Histopathological: plugging of the hair follicle in the skin before and after treatment
Biopsies will be taken for histopathological research
Time frame: 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
Histopathological: immunohistochemistry in the skin before and after treatment
Biopsies will be taken for histopathological research
Time frame: 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
Histopathological: AMP expression in the skin before and after treatment
Biopsies will be taken for histopathological research
Time frame: 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
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