| 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
|
|
|
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
|
|
|
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
|
|
|
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
- 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).
- 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
- Who will be able to view these files?
Response (Others) - Scientific journal Publication, researchers who have access to the journal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Publication in scientific journals
- 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.
- 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. |