To assess the effect of two treatment modalities: only the biologic drug adalimumab and adalimumab with surgery in the form of wide local excision for the management of hidradenitis suppurativa

A randomised controlled trial to evaluate the efficacy, safety, and patient satisfaction with wide local excision and adalimumab versus adalimumab alone in managing moderate to severe Hidradenitis Suppurativa of the axilla. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092740

Enrollment

Registered

2025-08-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Wide local excision with adalimumab: Surgery in the form of wide local excision will be added to adalimumab Control Intervention1: Adalimumab: Adalimumab injection in the dose of 160 mg

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients diagnosed with moderate to severe HS of the axillary region as per the Hidradenitis Suppurativa physician global assessment scale. Patients should have one or more active lesions. All patients should be on oral antibiotics two weeks before enrollment

Exclusion criteria

Exclusion criteria: Children less than 18 years of age, pregnant or lactating females, patients on oral corticosteroids within four weeks, patients on biologics within five-half-lives before baseline and clinically significant abnormal screening laboratory results as evaluated by the investigators

Design outcomes

Primary

Measure	Time frame
Efficacy in terms of improvement in the International Hidradenitis Suppurativa Severity Score System (IHS4) and safety in terms of complications, adverse events and serious adverse events associated (drug and surgery related) with the two groups. Timepoint: 4 weeks, 12 weeks, 24 weeks	—

Secondary

Measure	Time frame
Patient satisfaction using global impression change. Improvement in quality of life using DLQI, seven-day recall, work productivity, & activity impairment questionnaire as a measurement tool. Timepoint: 4 weeks, 12 weeks, 24 weeks	—

Countries

India

Contacts

Public ContactBhavni Oberoi

All India Institute of Medical Sciences

bhavni.oberoi@gmail.com7407424758

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026