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CTRI Number  CTRI/2025/08/092740 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 10/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   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 
Scientific Title of Study   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.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhavni Oberoi 
Designation  Dermatologist 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Dermatology, 3rd floor, New RAK OPD, AIIMS, New Delhi
Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India 
Phone  7407424758  
Fax    
Email  bhavni.oberoi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bhavni Oberoi 
Designation  Dermatologist 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Dermatology, 3rd Floor, New RAK OPD, AIIMS, New Delhi
Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India 
Phone  7407424758  
Fax    
Email  bhavni.oberoi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhavni Oberoi 
Designation  Dermatologist 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Dermatology, 3rd Floor, New RAK OPD, AIIMS, New Delhi
Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India 
Phone  7407424758  
Fax    
Email  bhavni.oberoi@gmail.com  
 
Source of Monetary or Material Support  
The study is being conducted at the All India Institute of Medical Sciences. Both the interventions are standard treatment options offered to the patients for this disease. Thus the cost of the treatment will be as per the hospital policy. There would have been no change if the patients were not enrolled for the study 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  AIIMS, Ansari nagar, New Delhi-110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhavni Oberoi  AIIMS, New Delhi  Department of Dermatology, 3rd Floor, New RAK OPD, AIIMS, Ansari Nagar, New Delhi
New Delhi
DELHI 		 7407424758

bhavni.oberoi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Adalimumab  Adalimumab injection in the dose of 160 mg, followed by 80mg after 2 weeks and 40 mg weekly from week 4  
Intervention  Wide local excision with adalimumab  Surgery in the form of wide local excision will be added to adalimumab 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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


 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.
 		 4 weeks, 12 weeks, 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
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.
 		 4 weeks, 12 weeks, 24 weeks 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   26/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be made available on demand as and when required

  6. For how long will this data be available start date provided 10-07-2027 and end date provided 10-12-2060?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The rationale for this study is grounded in the hypothesis that the combination of surgical excision and biologic therapy addresses both the local and systemic components of HS. While surgery effectively removes chronic lesions and sinus tracts, adalimumab targets the underlying inflammatory pathways, potentially reducing recurrence rates and improving long-term outcomes.

           We also wish to ascertain if patients with hidradenitis suppurativa lesions in sites that are amenable to surgical management have enough additional benefit from adding adalimumab to justify the increased cost of treatment.
           This study has the potential to significantly impact clinical practice by providing evidence-based guidelines for the comprehensive management of moderate to severe HS. It may help identify patient subgroups that benefit most from combined therapy, optimize treatment protocols, and improve patient quality of life. Additionally, understanding the safety profile of combined therapy will inform risk-benefit assessments in clinical decision-making.

 
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