Hidradenitis Suppurativa, Acne Inversa
Conditions
Keywords
laser hair removal therapy
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.
Interventions
PROCEDURENd:YAG laser hair removal
Using the Nd:YAG laser (cynergy), hair of the axillae will be removed.
DRUGClindamycin 1 % Topical Lotion
Clindamycin 1% lotion if needed
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
RCT with intervention and control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in IHS4 over time, measured between month 7 to month 12 | between month 7 to 12 | The IHS4 will be assessed monthly. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative IHS4 over month 7 to month 12 between the two groups | month 7 to 12 | IHS4 will be calculated on a monthly bases. IHS4 will be added up per visit which makes it a cumulative outcome |
| Change in skin related pain of the axillae, on a numerical rating scale (NRS), between baseline and month 12, and between groups. | every month for 12 months | NRS pain will be assessed |
| 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 | every month for 12 | Number of self reported flares will be assessed |
| Difference and change in quality of life measured with the Dermatologic Life Quality Index (DLQI) between baseline and month 12 and between groups. | every month for 12 months | PROM will be assessed |
| 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. | every month for 12 months | PROM will be assessed |
| Difference in patients satisfaction score at month 12 between groups. | every month for 12 months | patients satisfaction will be assessed |
| Cumulative IHS4 over month 7 to 12, correlated to hair loss after six months. | every month for 12 months | the amount of hair loss will be assessed and correlated to the cumulative IHS4 |
| Cumulative IHS4 calculated over a time period of 3, 9 and 12 months between groups. | every month for 12 months | The cumulative IHS4 will be assessed after 3, 9 and 12 months |
| Difference in pustule and papule count during visits over month 1 to 12 between groups. | every month for 12 months | the number of papules and pustules will be assessed |
| Difference in (cumulative) abscess en nodule count over month 1 to 12 between groups. | every month for 12 months | number of abscesses and nodules will be assessed |
| Change in skin related itch of the axillae, on a NRS, between baseline and month 12, and between groups. | every month for 12 months | NRS itch will be assessed |
| Difference of average duration of a flare, reported by the patient, over month 1 to 12 between groups. | every month for 12 months | Duration of a flare will be assessed |
| The difference in IHS4 and HS-PGA, measured every visit. | every month for 12 months | The IHS4 and HS-PGA will be assessed |
| Amount of clindamycin lotion use for both groups. | every month for 12 months | clindamycin 1% lotion will be weighted every visit |
| Difference in number of adverse events between groups. | every month for 12 months | safety will be assessed using adverse events |
| Incidence and severity of all adverse events (according to medDRA) will be analysed throughout the study. | every month for 12 months | safety will be assessed using adverse events |
| Histopathological: diameter hair shaft in axillary skin before and after treatment. | 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 | Biopsies will be taken for histopathological research |
| Histopathological: plugging of the hair follicle in the skin before and after treatment | 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 | Biopsies will be taken for histopathological research |
| Histopathological: immunohistochemistry in the skin before and after treatment | 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 | Biopsies will be taken for histopathological research |
| Histopathological: AMP expression in the skin before and after treatment | 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 | Biopsies will be taken for histopathological research |
| Difference in number of times escape medication has been used over month 1 to 12 between groups. | every month for 12months | Number of escape medication will be assessed |
Contacts
Primary ContactHessel van der Zee, MD, PhD
Outcome results
None listed