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A single-center, prospective, self-controlled, observational real-world study of the efficacy and safety of anti-IL-17A/F monoclonal antibody combined with non-ablative dot laser for the treatment of mild to moderate hidradenitis suppurativa

A single-center, prospective, self-controlled, observational real-world study of the efficacy and safety of anti-IL-17A/F monoclonal antibody combined with non-ablative dot laser for the treatment of mild to moderate hidradenitis suppurativa

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123514
Enrollment
Unknown
Registered
2026-04-27
Start date
2026-04-27
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Mild to moderate hidradenitis suppurativa.

Interventions

Bimekizumab with Unilateral Non?ablative Fractional Laser Cohort:Bimekizumab + NAFL (1565 nm)

Sponsors

The second affiliated hospital of Zhejiang University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients voluntarily participate in the study and sign the informed consent form; 2. Male or female participants aged >= 18 years and = 1 anatomical region and a total abscess and inflammatory nodule (AN) count >= 3; 5. Participants must have intolerance, contraindication, or inadequate response to oral antibiotic treatment for HS for at least 3 months, or have relapsed after stopping such treatment; 6. Have a basic understanding of the study purpose, the intervention, and possible side effects, and voluntarily sign the informed consent form in accordance with the spirit of the Declaration of Helsinki; 7. Agree to receive regular treatment, attend follow-up visits, and undergo the required examinations and tests as specified in the clinical study protocol; 8. Participants are planned to receive combination therapy with bimekizumab and non-ablative fractional laser (1565 nm), and have not previously received either bimekizumab or non-ablative fractional laser treatment.

Exclusion criteria

Exclusion criteria: 1. Known allergy to the study drug or its excipients; 2. Prior use of biologics or small molecule targeted agents; 3. Presence of tunnels on ultrasound at baseline; diagnosed with inflammatory diseases other than HS; history of chronic or recurrent infections; history of malignancy; 4. History of drug abuse, suicide attempt, or psychiatric disorders; 5. Participated in another clinical trial within the past 3 months; 6. Pregnant or breastfeeding women, or those planning to become pregnant during the study period; 7. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for inclusion; 8. Systemic use of corticosteroids within the past 4 weeks, or topical use within the past 2 weeks;

Design outcomes

Primary

MeasureTime frame
Number of Participants Achieving HiSCR (Hidradenitis Suppurativa Clinical Response) and no increase from baseline in abscess or draining tunnel (fistula/sinus tract) count.;

Secondary

MeasureTime frame
Duration of illness;

Countries

China

Contacts

Public ContactJiaqi Chen

The second affiliated hospital of Zhejiang University school of medicine

fatina@zju.edu.cn+86 571 8778 3753

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026