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CTRI Number  CTRI/2025/02/080856 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 17/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of exfoliative gel from carica papaya fruit extract in reducing acanthosis nigricans and its psychological impact  
Scientific Title of Study   Development of exfoliative cream with antiinflammatory properties from carica papaya fruit extract to reduce acanthosis nigricans 
Trial Acronym  Nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KOUSALYA K S  
Designation  Postgraduate,Paediatrics  
Affiliation  Saveetha medical college and hospital  
Address  Department of Paediatrics, First floor, Saveetha medical college and hospital, Thandalam, Kancheepuram district

Kancheepuram
TAMIL NADU
602105
India 
Phone  9600498876  
Fax    
Email  kousikumar98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  LAL D V  
Designation  Professor,program director,saveetha CDC,paediatrics  
Affiliation  Saveetha medical college and hospital  
Address  Department of Paediatrics, First floor, Saveetha medical college and hospital, Thandalam, Kancheepuram district

Kancheepuram
TAMIL NADU
602105
India 
Phone  7299938038  
Fax    
Email  drlaldv@gmail.com  
 
Details of Contact Person
Public Query  
Name  LAL D V  
Designation  Professor,program director,saveetha CDC,paediatrics  
Affiliation  Saveetha medical college and hospital  
Address  Department of Paediatrics, First floor, Saveetha medical college and hospital, Thandalam, Kancheepuram district

Kancheepuram
TAMIL NADU
602105
India 
Phone  7299938038  
Fax    
Email  drlaldv@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College and hospital, Saveetha nagar, Thandalam, Kancheepuram district, Tamil Nadu-602105 
 
Primary Sponsor  
Name  KOUSALYA K S  
Address  Department of Paediatrics, First floor, Saveetha Medical College and hospital, Saveetha nagar, Thandalam, Kancheepuram district, Tamil Nadu-602105, India  
Type of Sponsor  Other [Self] 
 
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 KOUSALYA K S   Saveetha Medical College and Hospital   Department of Paediatrics,First floor,Saveetha medical college and hospital,Saveetha nagar,Thandalam
Kancheepuram
TAMIL NADU 		 9600498876

kousikumar98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L83||Acanthosis nigricans,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Commercially available chemical ingredients cream/gel.   This group of children will use commercially available products with chemical based ingredients  
Intervention  Exfoliating gel- carica papaya fruit extract  Carica papaya gel containing anti inflammatory and keratolytic properties (application of 5g of gel over the skin hyperpigmented area), to reduce the hyperpigmentation, improve the skin texture, incorporated with natural aloe Vera, glycerine. This gel will be used daily for 1month duration and Alison analysing their psychological impact. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  Paediatric population from 10years to 19years with acanthosis nigricans, obesity, diabetes mellitus type 2 will be included in the study 
 
ExclusionCriteria 
Details  Sick children ,Age group less than 10 years,Underweight children with no acanthosis nigricans will not be included in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the trial would be a significant reduction in the severity of Acanthosis Nigricans (AN), by using acanthosis nigricans scoring chart, and this extract will show improvements in skin appearance and texture which will be evaluated through clinical assessments.  3months 
 
Secondary Outcome  
Outcome  TimePoints 
The overall outcome is to demonstrate both clinical improvement in skin appearance, texture and psychological benefits of the gel.   3months 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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)   28/02/2025 
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="0"
Months="6"
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 - 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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 - Proposals should be directed to [kousikumar98@gmail.com].

  6. For how long will this data be available start date provided 01-06-2025 and end date provided 31-10-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Acanthosis nigricans is a dermatological condition characterized by hyperpigmented, velvety, and thickened skin, typically found in body folds and creases such as the neck, armpits, and groin. It is often associated with metabolic conditions, including insulin resistance, obesity, hormonal imbalances, and certain medications.While primarily a cosmetic concern, acanthosis nigricans can also serve as an indicator of underlying systemic health issues, making effective management strategies crucial.The condition significantly impacts the quality of life for many individuals. Carica papaya, commonly known as papaya, is a tropical fruit rich in bioactive compounds, including papain, chymopapain, vitamins, minerals, keratolytic and antioxidants property. Carica papa fruit extract is formulated into a gel form and will be applied as per instructions for easy use. Acanthosis nigricans severity was evaluated both pre- and post-application using the Acanthosis Nigricans Scoring Chart. The research conducted as a randomised, single blinded, parallel group study, focusing on reducing the hyperpigmentation of the affected area and analysing the psychological impact of the participants. It also promotes replacing chemical-based products with this natural alternative for reducing acanthosis nigricans. 
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