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CTRI Number  CTRI/2025/12/098348 [Registered on: 03/12/2025] Trial Registered Prospectively
Last Modified On: 03/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy Of Oral Isotretinoin With Levocetirizine Vs Oral Isotretinoin Monotherapy In Acne Vulgaris: A Randomised Controlled Trial 
Scientific Title of Study   Efficacy Of Oral Isotretinoin With Levocetirizine Vs Oral Isotretinoin Monotherapy In Acne Vulgaris: A Randomised Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Debasmita Behera 
Designation  Professor  
Affiliation  Kalinga institute of medical sciences 
Address  Department of dermatology kalinga institute of medical science, khushabhadra, campus 5

Cuttack
ORISSA
701524
India 
Phone    
Fax    
Email  drdbehera427@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Paridhi vaidh 
Designation  Junior resident 
Affiliation  kalinga institute of medical science 
Address  Department of dermatology kalinga institute of medical science, khushabhadra, campus 5

Cuttack
ORISSA
701524
India 
Phone  9831055448  
Fax    
Email  drparidhivaidh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Paridhi vaidh 
Designation  Junior resident 
Affiliation  kalinga institute of medical science 
Address  Departement of dermatology kalinga institute of medical science, khushabhadra, campus 5

Cuttack
ORISSA
701524
India 
Phone  9831055448  
Fax    
Email  drparidhivaidh@gmail.com  
 
Source of Monetary or Material Support  
Kalinga institute of medical sciences, kalinga institute of medical science, khushabhadra, campus 5, bhubaneshwar, orissa 751024 
 
Primary Sponsor  
Name  Dr Paridhi vaidh  
Address  Kalinga institute of medical sciences, kalinga institute of medical science, khushabhadra, campus 5, bhubaneshwar, orissa 751024 
Type of Sponsor  Other [] 
 
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 
Paridhi vaidh  Kalinga institute of medical sciences  Department of dermatology Kalinga institute of medical sciences, kalinga institute of medical science, khushabhadra, campus 5, bhubaneshwar, orissa 751024
Cuttack
ORISSA 		 09831055448

drparidhivaidh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC KIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L700||Acne vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Isotretinoin  1 tab once daily after food 
Intervention  Isotretinoin plus leveocetrizine   Isotretinoin 1 tab once daily after food plus levocetrizine 1 tab once daily bedore food at night for 12 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patients aged more than 18 years with a diagnosis of moderate to severe acne vulgaris
2. Patients available for regular follow-up visits during the study period
 
 
ExclusionCriteria 
Details  1.Patients with a known allergy or intolerance to isotretinoin.
2.Patients with deranged LFT and Lipid Profile.
3.Patients planning for pregnancy, Pregnant or lactating women.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine whether Isotretinoin with levocetirizine is more effective than isotretinoin alone for treating acne vulgaris.
 		 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of combination therapy on a patient’s overall quality of life  12 weeeks  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   17/12/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This randomized, assessor-blinded pilot trial compares oral isotretinoin plus levocetirizine versus isotretinoin alone in 60 adults with moderate to severe acne vulgaris to determine whether combination therapy offers superior clinical outcomes. Acne is a multifactorial inflammatory condition, and while isotretinoin is the gold standard, antihistamines may enhance its efficacy by reducing inflammation, itch, squalene and sebum levels, and scratching-related excoriation. Participants are randomised into two groups, assessed at baseline and then every four weeks for 12 weeks using GAGS, VAS, DLQI, and adverse event monitoring. The study hypothesizes that adding levocetirizine will lead to greater reductions in acne severity and improved quality of life. Statistical analysis will use t-tests, Mann-Whitney tests, and correlation methods through SPSS v26.0 to compare outcomes between groups. The expected conclusion is that the combination regimen will outperform isotretinoin monotherapy in both efficacy and symptomatic relief.  
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