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Long-term efficacy and safety of microwave ablation in the treatment of mild axillary hidradenitis suppurativa: a randomized intra-patient controlled trial

Long-term efficacy and safety of microwave ablation in the treatment of mild axillary hidradenitis suppurativa: a randomized intra-patient controlled trial - The WAVE trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44256
Enrollment
20
Registered
2017-08-22
Start date
2017-10-12
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acne ectopica acne inversa

Interventions

Twenty patients will be randomly allocated to a one-sided single MWA treatment in one axillary region with a miraDry device.
Hidradenitis suppurativa
Microwave ablation
Sweat gland

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Key inclusion criteria: - Adult (* 18 years old) patients suffering from HS; - Minimum of 3 AN-count located in each axilla; - Maximum of 5 AN-count located in each axilla.

Exclusion criteria

Exclusion criteria: Key exclusion criteria: - >1 abscess or draining fistula per axillary area; - AN-count * 5 in other regions than the axillary area; - Surgical scars covering more than 25% of each individual axillary area; - Previous successful use of laser or light therapy for hair removal in the axillary area; - Use of botulinum toxin injections 6 months prior to randomization. - Pregnancy (at time of treatment)

Design outcomes

Primary

MeasureTime frame
Clinical efficacy: Hidradenitis Suppurativa Clinical Response (HiSCR 50%), based on the lesion count (AN count).

Secondary

MeasureTime frame
- PROMs: number of flares, numerical rating scale on pain and itch, patient satisfaction; - Average number of hair containing follicles (dermatoscopy); - The extent of sweat production (starch-iodine test); - Safety parameters (adverse events).

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)