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CTRI Number  CTRI/2024/05/066612 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 29/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Single Arm Study 
Public Title of Study   A study of male pattern hair loss, its association with common skin diseases and bahavioural parameters( Aggression and Anxiety) 
Scientific Title of Study   A study of androgenetic alopecia, its association with common cutaneous disorders and behavioural parameters in men. 
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 Yaksh P Oza 
Designation  2nd year PG Resident 
Affiliation  GCS Medical College Hospital & Research Centre 
Address  Department of Dermatology, GCS Medical College, Hospital & Research Centre Opp. DRM Office, Near Chamunda Bridge, Naroda Road, Ahmedabad

Ahmadabad
GUJARAT
380025
India 
Phone  8080898912  
Fax    
Email  dryakshoza@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan H Patel 
Designation  Professor and HOD 
Affiliation  GCS Medical College Hospital & Research Centre 
Address  Department of Dermatology,GCS Medical College, Hospital & Research Centre OPD number 35 Opp. DRM Office, Near Chamunda Bridge, Naroda Road, Ahmedabad

Ahmadabad
GUJARAT
380025
India 
Phone  9925011309  
Fax    
Email  nayan.patel@gcsmc.org  
 
Details of Contact Person
Public Query  
Name  Dr Yaksh P Oza 
Designation  2nd year PG Resident 
Affiliation  GCS Medical College Hospital & Research Centre 
Address  Department of Dermatology, GCS Medical College, Hospital & Research Centre Opp. DRM Office, Near Chamunda Bridge, Naroda Road, Ahmedabad

Ahmadabad
GUJARAT
380025
India 
Phone  8080898912  
Fax    
Email  dryakshoza@gmail.com  
 
Source of Monetary or Material Support  
GCS medical college, Hospital and Research center, Ahmedabad 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Yaksh P Oza  GCS Medical College Hospital & Research Centre  GCS Medical College, Hospital & Research Centre Opp. DRM Office, Near Chamunda Bridge, Naroda Road, Ahmedabad
Ahmadabad
GUJARAT 		 8080898912

dryakshoza@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee GCS medical college,hospital and reasearch centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L649||Androgenic alopecia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  1. Patients having clinical presentation suggestive of androgenetic alopecia.
2. Patient willing to give written informed consent for study.
 
 
ExclusionCriteria 
Details  1. Any pre-existing psychiatric disorders like depression, psychosis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To estimate clinical association between androgenetic alopecia and cutaneous disorders like acne, hyperseborrhea, hidradenitis suppurativa.
2. To estimate clinical association between androgenetic alopecia and behavioural parameters like anxiety and aggression.
 		 it is a cross sectional single visit study on day 0. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To estimate the prevalence of androgenetic alopecia in tertiary care unit.
2. To estimate other clinic-epidemiological parameters like age of onset, grade at the time of presentation, family history.
3. To estimate the nailfold capillaroscopic changes in androgenetic alopecia.
 		 it is a cross sectional single visit study on day 0.
 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   13/05/2024 
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="3"
Months="0"
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 - NO
Brief Summary   Male androgenetic alopecia (MAA, male pattern baldness) is the most common cause of hair loss in men. The hair loss is progressive. Gradual conversion of terminal hairs into vellus hairs occurs in a highly reproducible pattern, denudes the scalp and leads to baldness. While some degree of androgen dependent hair loss is universal after puberty, the prevalence of alopecia of sufficient severity to warrant a diagnosis of balding increases with advancing age. The morbidity of MAA is predominately psychological, although baldness is a significant risk factor for both melanoma and non­melanoma skin cancer of the scalp. MAA has a variable psychosocial impact on the affected individual, however premature MAA is more likely to cause emotional distress.it is important to study correlation between MAA and Psychiatric manifestations. 
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