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CTRI Number  CTRI/2026/01/101285 [Registered on: 15/01/2026] Trial Registered Prospectively
Last Modified On: 15/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study on safety outcomes of aesthetic procedures. 
Scientific Title of Study   A study to evaluate the incidence and prognosis of complications in various aesthetic procedures. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bharati Kannamma 
Designation  Senior resident (M.D.D.V.L.) 
Affiliation  Pacific Medical College and Hospital, Udaipur 
Address  room no. 3, basement floor, Dermatology OPD, Pacific Medical College and Hospital, Bhillon ka Bedla, Prattapura

Udaipur
RAJASTHAN
313024
India 
Phone  07010437600  
Fax    
Email  drbharathikannamma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shivani Bhardwaj 
Designation  Associate professor (M.D.D.V.L.) 
Affiliation  Pacific Medical College and Hospital, Udaipur 
Address  Room no.1, basement floor, dept. of Dermatology, Venereology and Leprosy.Pacific Medical college and hospital, Bhillon ka bedla, Prattapura, Udaipur, Rajasthan - 313024

Udaipur
RAJASTHAN
313024
India 
Phone  08000574060  
Fax    
Email  shivani00444@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shivani Bhardwaj 
Designation  Associate professor (M.D.D.V.L.) 
Affiliation  Pacific Medical College and Hospital, Udaipur 
Address  Room no.1, basement floor, dept. of Dermatology, Venereology and Leprosy.Pacific Medical college and hospital, Bhillon ka bedla, Prattapura, Udaipur, Rajasthan - 313024

Udaipur
RAJASTHAN
313024
India 
Phone  08000574060  
Fax    
Email  shivani00444@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Study conductor and Pacific Medical college and hospital 
Address  Room no.001, basement floor, Dermatology OPD, Pacific Medical College and hospital, Udaipur-313024 
Type of Sponsor  Other [Self and PMCH] 
 
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 
Shivani Bhardwaj  Pacific Medical college and hospital  Room no. 3, Basement floor, Dermatology OPD, Pacific Medical college and hospital, Bhillon ka bedla, Prattapura, Udaipur, Rajasthan - 313001
Udaipur
RAJASTHAN 
08000574060

shivani00444@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pacific Medical college & hospital Udaipur instituitional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  a.Willing and able to provide written informed consent for participation and follow-up b.Patients undergoing aesthetic treatments c.Patients with good compliance and without unrealistic expectations
 
 
ExclusionCriteria 
Details  a.Pregnant or lactating women b.Active infection at procedure site c.Uncontrolled systemic diseases that increase procedural risk d.Patients on anticoagulants or with bleeding diathesis e.Patients with active autoimmune conditions f.Patients with oral isotretinoin use in preceding 6 months
Patients with any contraindications specific to the planned procedure 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To determine the incidence of complications across various aesthetic procedures.
2.To evaluate and classify the types and severity of the complications.
3.To assess the prognosis, including duration, need for intervention, treatment response and long-term sequelae. 
Immediate post procedure, 1st week, 2nd week, 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   01/02/2026 
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)  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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response (Others) -  photographs after de-identification
  3. Who will be able to view these files?
    Response (Others) -  Scientific journal Publication, researchers who have access to the journal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Publication in scientific journals

  6. For how long will this data be available start date provided 20-02-2026 and end date provided 31-12-2055?
    Response - Immediately following publication. No end date.

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

1.    Title of the project :

 

A study to evaluate the incidence and prognosis of complications in various aesthetic procedures.

 

 

2.     Background :

 

A.   Rationale :

 

The use of aesthetic dermatology procedures is rapidly increasing, leading to a greater need to understand complication patterns and their burden, especially in darker skin types where pigmentary and textural changes are more common. Existing data are largely from Western populations and do not accurately reflect the risks observed in Fitzpatrick III–VI skin.

There is limited Indian evidence on the incidence, types and prognosis of complications across common aesthetic procedures. A focused study will help identify risk factors, understand the expected recovery patterns and support in development of safer procedure protocols, better counselling practices and practical management guidelines.

 

B.   Expected outcome & Application :

 

The study is expected to provide reliable data on frequency, types and prognostic patterns of complications that occur in common aesthetic procedures. It will also help identify key risk factors and guide in development of safer practice protocols, improved patient counselling and evidence-based management strategies for complications.

 

3.    Aim and objectives :

 

 

AIM- 

 

        To evaluate the incidence and prognosis of complications in various aesthetic procedures.

 

OBJECTIVE: 

 

1.     To determine the incidence of complications across various aesthetic procedures.

2.     To evaluate and classify the types and severity of the complications.

3.     To assess the prognosis, including duration, need for intervention, treatment response and long-term sequelae

Data collection methods including settings & periodicity: Patient registers, History taking, follow-up.

List variable-wise statistical tests to be used for data analysis: Percentages, proportions, descriptive analysis, chi square test and t-test.

 
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