The Efficacy of Laser Hair Removal Therapy in Patients With Mild to Moderate HS, a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 主要终点
- Difference in IHS4 over time, measured between month 7 to month 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IHS4 mild to moderate, without tunnels in the axillae.
- •HS activity in at least one axilla.
- •Age 18 years and over.
排除标准
- •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.
研究组 & 干预措施
Control group, clindamycin 1% lotion if needed, standard care
Patients will use clindamycin 1% lotion of needed for 1 year.
干预措施: Clindamycin 1 % Topical Lotion (Drug)
结局指标
主要结局
Difference in IHS4 over time, measured between month 7 to month 12
时间窗: between month 7 to 12
The IHS4 will be assessed monthly.
次要结局
- 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)
- 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)
- Cumulative IHS4 over month 7 to 12, correlated to hair loss after six months.(every month for 12 months)
- Cumulative IHS4 calculated over a time period of 3, 9 and 12 months between groups.(every month for 12 months)
- Change in skin related itch of the axillae, on a NRS, between baseline and month 12, and between groups.(every month for 12 months)
- Difference in number of times escape medication has been used over month 1 to 12 between groups.(every month for 12months)
- The difference in IHS4 and HS-PGA, measured every visit.(every month for 12 months)
- Amount of clindamycin lotion use for both groups.(every month for 12 months)
- Incidence and severity of all adverse events (according to medDRA) will be analysed throughout the study.(every month for 12 months)
- 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)
- Cumulative IHS4 over month 7 to month 12 between the two groups(month 7 to 12)
- 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)
- Difference in patients satisfaction score at month 12 between groups.(every month for 12 months)
- Difference in pustule and papule count during visits over month 1 to 12 between groups.(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.(every month for 12 months)
- 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)
- Difference in (cumulative) abscess en nodule count over month 1 to 12 between groups.(every month for 12 months)
- Difference of average duration of a flare, reported by the patient, over month 1 to 12 between groups.(every month for 12 months)
- Difference in number of adverse events between groups.(every month for 12 months)
- 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)
- 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)
研究者
Hessel H van der Zee, MD, PhD
MD, PhD
Erasmus Medical Center