Efficacy of Laser Hair Removal Therapy in HS

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy of Laser Hair Removal Therapy in Patients With Mild to Moderate HS, a Randomized Controlled Trial.

Conditions
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Hidradenitis Suppurativa, Acne Inversa

Intervention / Treatment
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* Procedure: Nd:YAG laser hair removal
* Drug: Clindamycin 1 % Topical Lotion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT with intervention and control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group, laser hair removal therapy<br>Patients will undergo 6 monthly laser hair removal treatments with de Nd:YAG laser. After 6 months, a 6 follow up will start, using clindamycin 1% lotion if needed. | Procedure: Nd:YAG laser hair removal<br>* Using the Nd:YAG laser (cynergy), hair of the axillae will be removed.<br>|
| Active Comparator: Control group, clindamycin 1% lotion if needed, standard care<br>Patients will use clindamycin 1% lotion of needed for 1 year. | Drug: Clindamycin 1 % Topical Lotion<br>* Clindamycin 1% lotion if needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in IHS4 over time, measured between month 7 to month 12 | The IHS4 will be assessed monthly. | between month 7 to 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | every month for 12 months | 
| Difference in patients satisfaction score at month 12 between groups. | patients satisfaction will be assessed | 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 | 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 | 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 | 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 | 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 | 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 | every month for 12 months | 
| The difference in IHS4 and HS-PGA, measured every visit. | The IHS4 and HS-PGA will be assessed | every month for 12 months | 
| Amount of clindamycin lotion use for both groups. | clindamycin 1% lotion will be weighted every visit | every month for 12 months | 
| Difference in number of adverse events between groups. | safety will be assessed using adverse events | 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 | every month for 12 months | 
| Histopathological: diameter hair shaft in axillary skin before and after treatment. | Biopsies will be taken for histopathological research | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser hair removal therapy