The efficacy of laser hair removal therapy in patients with mild to moderate HS, a randomized controlled trial.

The efficacy of laser hair removal therapy in patients with mild to moderate HS, a randomized controlled trial. - Laser hair removal in HS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53989

Enrollment

Registered

2023-07-06

Start date

2023-09-18

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Acne inversa Verneuil's disease Acne inversa

Interventions

The RCT consist of two periods of 6 months. From month 1 to month 6, the intervention group will undergo six monthly laser hair removal treatments in the axillae or inguinal area combined with clind

Eligibility

Age

16 Years to 99 Years

Inclusion criteria

Inclusion criteria: - IHS4 mild to moderate, without tunnels in the axillae and/or inguinal area. - HS activity in at least one axilla or at least one side of the inguinal area. - Age 16 years and over.

Exclusion criteria

Exclusion criteria: - If the patient is not able to give informed consent. - If the patient is allergic to clindamycin lotion. - If the patient uses systemic therapy for HS such as antibiotics or biologicals.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is the difference in IHS4 between the intervention group and the control group over month 7 to 12, using a repeated measure analysis.	—

Secondary

Measure	Time frame
Patient reported outcome measures (for the axillae): - Skin related pain of the axillae, on a numerical rating scale (NRS) - Skin related itch of the axillae, on a NRS - Self-reported flares (number of flares reported by the patients in the last 4 weeks) - Quality of life measured with the Dermatologic Life Quality Index (DLQI) and the Hidradenitis Suppurativa Quality of Life score (HiSQOL), during the study. - Difference in patients satisfaction score Clinical efficacy (for the axillae): - Difference in cumulative IHS4 over month 7 to 12 between both groups. - Cumulative IHS4, correlated to hair loss over month 7 till 12. - Cumulative IHS4, calculated over a time period of 3, 9 and 12 months - Pustule and papule count during visits during the study. - (cumulative) Abscess en nodule count during the study. - Number of times escape medication has been used during the study. - Average duration of a flare, reported by the patient, during the study. - The IHS4 and HS-PGA, measured every visit during the study. - Amount of clindamycin lotion use during the study. - Difference in the cumulative dose of laser energy used. Safety and tolerability: - Number of adverse events during the study. - Incidence and severity of all adverse events (according to medDRA) will be analyzed throughout the study. Biopsy: - Histopathological: diameter hair shaft, plugging, immunohistochemistry (keratin subtype expression, inflammatory markers), antimicrobial peptides (AMPs) expression in axillary skin before and after treatment (optional)	—

Measure

Time frame

Patient reported outcome measures (for the axillae): - Skin related pain of the axillae, on a numerical rating scale (NRS) - Skin related itch of the axillae, on a NRS - Self-reported flares (number of flares reported by the patients in the last 4 weeks) - Quality of life measured with the Dermatologic Life Quality Index (DLQI) and the Hidradenitis Suppurativa Quality of Life score (HiSQOL), during the study. - Difference in patients satisfaction score Clinical efficacy (for the axillae): - Difference in cumulative IHS4 over month 7 to 12 between both groups. - Cumulative IHS4, correlated to hair loss over month 7 till 12. - Cumulative IHS4, calculated over a time period of 3, 9 and 12 months - Pustule and papule count during visits during the study. - (cumulative) Abscess en nodule count during the study. - Number of times escape medication has been used during the study. - Average duration of a flare, reported by the patient, during the study. - The IHS4 and HS-PGA, measured every visit during the study. - Amount of clindamycin lotion use during the study. - Difference in the cumulative dose of laser energy used. Safety and tolerability: - Number of adverse events during the study. - Incidence and severity of all adverse events (according to medDRA) will be analyzed throughout the study. Biopsy: - Histopathological: diameter hair shaft, plugging, immunohistochemistry (keratin subtype expression, inflammatory markers), antimicrobial peptides (AMPs) expression in axillary skin before and after treatment (optional)

—

Countries

Netherlands

Contacts

Public ContactH.H. Zee

Erasmus MC, Universitair Medisch Centrum Rotterdam

h.vanderzee@erasmusmc.nl0107040110

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026