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CTRI Number  CTRI/2024/06/068994 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Comparing two drugs in participants having hairless patches and noting the outcome as hair regrowth seen in the participants after 3 months of completing treatment.  
Scientific Title of Study   A Comparitive study of Oral Apremilast and Oral Minipulse Betamethasone therapy in Alopecia Areata : A Trichoscopic assessment of treatment outcomes 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaishnavi Puri 
Designation  Junior ResidentMD 
Affiliation  Kasturba Medical college Mangalore 
Address  Skin OPD - 9, KMC Hospital, Attavar, Mangalore Dakshina Kannada KARNATAKA 575002 India

Dakshina Kannada
KARNATAKA
575002
India 
Phone    
Fax    
Email  vaishnavi2.kmcmlr2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Kashinath Nayak  
Designation  Associate Professor  
Affiliation  Kasturba Medical College ,Mangalore 
Address  Skin OPD - 9 KMC Hospital, Attavar, Mangalore Dakshina Kannada KARNATAKA 575002 India

Dakshina Kannada
KARNATAKA
575002
India 
Phone  0  
Fax    
Email  kashi.nayak@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Kashinath Nayak  
Designation  Associate Professor  
Affiliation  Kasturba Medical College ,Mangalore 
Address  Skin OPD - 9, KMC Hospital, Attavar, Mangalore Dakshina Kannada KARNATAKA 575002 India

Dakshina Kannada
KARNATAKA
575002
India 
Phone  0  
Fax    
Email  kashi.nayak@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Mangalore, Light House Hill Road, Hampankatta, Mangalore, Karnataka, 575001 
 
Primary Sponsor  
Name  Dr Vaishnavi Puri 
Address  Skin OPD - 9, KMC Hospital, Attavar, Mangalore, Karnataka, 575002 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaishnavi Puri  District Wenlock Hospital Mangalore  Hampankatta, Mangalore Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA 		 8094930826

vaishnavi2.kmcmlr2023@learner.manipal.edu 
Dr Vaishnavi Puri  KMC Hospital,Attavar Mangalore  Attavar, Mangalore Dakshina Kannada
Dakshina Kannada
KARNATAKA 		 8094930826

vaishnavi2.kmcmlr2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
Institutional Ethics Committee,Kasturba Medical College ,Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L639||Alopecia areata, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral Apremilast   Oral Apremilast 30 mg twice daily per oral route for 12 weeks in alopecia areata patients, Under the dermatologist consultants discretion. 
Comparator Agent  Oral minipulse betamethasone   Oral minipulse betamethasone 5mg twice a week per oral route in alopecia areata patients for 12weeks Under dermatologist consultants discretion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients willing to give consent.
Patients of alopecia areata with more than equal to 3 patches or scalp area involving more than 10% . 
 
ExclusionCriteria 
Details  1)Patients who have received topical and systemic medications for alopecia areata upto 1 month before.
2) Pregnant and lactating women.
3) Patients with history of active TB or incompletely treated TB.
4) Patients with psychiatric illness.
5) Patients with HIV, Hepatitis B and Malignancy.
6) History of serious side effects to phosphodiesterase type 4 inhibitors – Apremilast.
7) Patients with severe renal impairment, hepatic impairment cardiac diseases. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study will measure hair regrowth in patients of alopecia areata after treatment with Oral apremilast and oral minipulse Betamethasone and signs noted on trichoscopy and improvement in SALT Score after completing 12 weeks of treatment   12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Check for any adverse effects  4weeks ,8weeks & 12 weeks  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   01/07/2024 
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 Yet Recruiting 
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 - NO
Brief Summary  
It is a study  to evaluate the efficacy safety and  adverse effects of Oral Apremilast and oral minipulse betamethasone in patients of lipecia areata. A 3month follow up will be done and results will be compared from baseline using trichoscopy with proper consent . Relevant investigations will be done before starting the drugs . Treatment will be started at the dermatologist’s discretion and will be observed by the primary investigtor with a monthly follow up for 3 months.
 
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