Long-term Efficacy and Safety of Microwave Ablation in the Treatment of Mild Axillary Hidradenitis Suppurativa
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Hidradenitis Suppurativa Clinical Response (HiSCR50)
研究概览
简要总结
With microwave ablation (MWA), using the heat generated from electromagnetic waves in the microwave energy spectrum, hair follicles and apocrine glands in the (hypo)dermis are ablated through thermolysis. MWA was recently approved for the treatment of axillary hyperhidrosis (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of hairs and sweat glands, the investigators hypothesize a beneficial and long-term sustainable preventive effect of MWA in HS patients.
详细描述
Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease of the hair follicle, and is predominantly located in the axillary, inguinal and anogenital regions. Current treatment options for HS include systemic oral antibiotics, anti-TNFα, and surgery, which are used to treat the consequences rather than treating the primary pathogenesis of HS. With microwave ablation (MWA), using the heat generated from electromagnetic waves in the microwave energy spectrum, hair follicles, eccrine and apocrine glands in the (hypo)dermis are ablated through thermolysis. MWA was recently approved for the treatment of axillary hyperhidrosis (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of hairs and sweat glands, the investigators hypothesize a beneficial and long-term sustainable preventive effect of MWA in HS patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 18 years of age) male or female patients with mild HS and able to participate, willing to give written informed consent and to comply with the study restrictions;
- •Minimum of 3 AN-count located in each axilla;
- •Maximum of 5 AN-count located in each axilla.
排除标准
- •Patients with >1 abscesses or draining fistulas per axillary region;
- •AN-count ≥ 5 in other regions than the axillary area;
- •Any current and / or recurrent clinically significant skin condition in the treatment area other than HS;
- •Surgical scars covering more than 25% of each individual axillary area;
- •Open surgical wound(s) in the axillary areas prior to randomization;
- •Use of anti-inflammatory or immunomodulatory medication (intralesional corticosteroids, oral antibiotics, biologics, prednisone) within 2 weeks prior to randomization;
- •Contraindication for miraDry therapy;
- •Heart pacemakers and other electronic device implants;
- •Supplemental oxygen;
- •Resistance to or history of intolerance of local anesthesia including lidocaine and epinephrine;
- •Previous use of miraDry therapy or MWA in the axillary area;
- •Previous use of successful laser or light therapy for hair removal in the axillary area;
- •Use of botulinum toxin injections 6 months prior to randomization;
- •Use of aluminiumhydroxychloride 1 month prior to randomization;
- •Pregnant or lactating women at randomization.
研究组 & 干预措施
Microwave ablation
One-sided single microwave ablation (MWA) treatment in one axillary region with a miraDry device.
干预措施: Microwave ablation (Device)
No microwave ablation
Lesion intervention in the non-MWA treated contralateral axilla consists of once daily topical clindamycin 1% lotion.
结局指标
主要结局
Hidradenitis Suppurativa Clinical Response (HiSCR50)
时间窗: 6 months
The proposed definition of 50% responders to treatment (HiSCR50 achievers) is: (i) at least a 50% reduction in ANs, (ii) no increase in the number of abscesses, and (iii) no increase in the number of draining fistulas from baseline
次要结局
- Hidradenitis Suppurativa Clinical Response (HiSCR30)(6 months)
- Patient-reported number of HS flares(6 months)
- Average number of hair containing follicles(6 months)
- Extent of sweat production(6 months)
- Patient-reported pain and pruritus(6 months)
- Incidence of (treatment-emergent) adverse events(6 months)
研究者
M.B.A. van Doorn
MD, PhD
Erasmus Medical Center