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CTRI Number  CTRI/2024/04/065823 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 29/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   compararing the efficacy of electrosurgery and trichloroacetic acid application in xanthelasma palpebrarum 
Scientific Title of Study   comparative efficacy of electrosurgery and trichloroacetic acid application in xanthelasma palpebrarum 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhurpreet kaur 
Designation  Junior Resident 
Affiliation  Government medical college and hospital 
Address  Department of Dermatology Floor 5 Block D GMCH 32 Chandigarh 160030 India
Department of Dermatology Floor 5 Block D GMCH 32 Chandigarh 160030 India
Chandigarh
CHANDIGARH
160030
India 
Phone  7508942567  
Fax    
Email  madhurpreet97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  G P Thami 
Designation  Proffesor and Head of Department 
Affiliation  government medical college and hospital 
Address  Department of Dermatology Floor 5 Block D Government medical college and Hospital sector 32 Chandigarh 160030 India
Department of Dermatology Floor 5 Block D Government medical college and Hospital sector 32 Chandigarh 160030 India
Chandigarh
CHANDIGARH
160030
India 
Phone  9646121544  
Fax    
Email  thamigp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Madhurpreet kaur 
Designation  Junior Resident 
Affiliation  government medical college and hospital 
Address  Department of Dermatology Floor 5 Block D Government medical college and Hospital sector 32 Chandigarh 160030 India
Department of Dermatology Floor 5 Block D Government medical college and Hospital sector 32 Chandigarh 160030 India
Chandigarh
CHANDIGARH
160030
India 
Phone  7508942567  
Fax    
Email  madhurpreet97@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology Floor 5 Block D Government medical college and Hospital sector 32 Chandigarh 160030 India 
 
Primary Sponsor  
Name  government medical college and hospital 
Address  sector 32 chandigarh 
Type of Sponsor  Government medical college 
 
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 Madhurpreet kaur  Government medical college and hospital  Department of Dermatology Floor 5 Block D Government medical college and Hospital sector 32 Chandigarh 160030 India
Chandigarh
CHANDIGARH 		 7508942567

madhurpreet97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparative efficacy of electrosurgery and trichloroacetic acid application in Xanthelasma Palpebrarum  ll patients of xanthelasma palpebrarum of 18-50 years of age with a clinical diagnosis of xanthelasma palpebrarum attending the dermatology outpatient department at GMCH-32, Chandigarh shall be recruited in the study. The patients shall be included keeping in view the inclusion and exclusion criteria. The clinical diagnosis of xanthelasma Palpebrarum shall be made by the two independent dermatologists. 21 patients conforming to the above-mentioned shall be selected for the study. At one ye, Trichloroacetic acid shall be applied at 3 weekly intervals for maximum uptill 3 months, and electrosurgery shall be done on the other eye at 3 weekly intervals uptill 3 months. 
Comparator Agent  electrosurgery  Electrosurgery is modality frequently used in dermatosurgery used for cutting or coagulation of superficial or deep tissues in the skin. The skin is bad conductor of electrical energy. Therefore, the energy transmitted to it, builds up in it and is converted into heat. 
Comparator Agent  trichloroacetic acid   trichloroacetic acid is a chemical peel used as chemical cautery used for local destruction of tissue. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  All patients of xanthelasma palpebrarum of 18-50 years of age with a clinical diagnosis of xanthelasma palpebrarum attending the dermatology outpatient department at GMCH-32, Chandigarh shall be recruited in the study. The patients shall be included keeping in view the inclusion and exclusion criteria. The clinical diagnosis of xanthelasma Palpebrarum shall be made by the two independent dermatologists. 21 patients conforming to the above-mentioned shall be selected for the study.  
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA:
1. Patients with known allergy to lignocaine
2. Patient on anticoagulants/bleeding tendencies/ with known cardiac illness/pacemakers.
3. Patients with atopy/periorbital dermatitis/ any active disease around eyes
4. Patients with known diabetes/ poor glycaemic control/on immunosuppression.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To compare the clinical efficacy of electrosurgery and trichloroacetic acid in the treatment of xanthelasma palpebrarum.
 		 18 months
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the adverse effects of these modalities of treatment in xanthelasma palpebrarum.

 		 18 months 
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
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   Phase 3 
Date of First Enrollment (India)   01/05/2024 
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="1"
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 - Anyone

  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 [madhurpreet97@gmail.com].

  6. For how long will this data be available start date provided 05-11-2025 and end date provided 05-09-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A prospective clinical trial comparing the efficacy of trichloroacetic acid and electrosurgery  in the treatment of xanthelasma palpebrarum.All patients of xanthelasma palpebrarum attending the dermatology outpatient department at GMCH-32, Chandigarh shall be recruited in the study.  The patients shall be included keeping in view the inclusion and exclusion criteria. The clinical diagnosis of xanthelasma Palpebrarum shall be made by the two independent dermatologist. 21 patients conforming to the above-mentioned shall be selected for the study.Patient of xanthelasma palpebrarum shall be selected with the help of random table method.21 patients shall be recruited. For each recruited patient, electrosurgery will be done on one eye and 100% trichloroacetic acid application shall be done on the other eye. For baseline assessment, photographs along with measurement of the lesions along two dimensions shall be  noted.Clinical photographs will be taken and labelled by specific numbers for each patient before starting the treatment and at each follow up visit. The final outcome shall be scored on a 0-4 point scale: 

0 – no improvement

1 – moderate improvement ( up to 25% clearing of the lesion)

2 – satisfactorily result (25-50% clearing of the lesion)

3 – good result (50-75% clearing of the lesion)

4 – excellent result (>75% clearing of the lesion)

Final assessment of the patients shall be done at the end of 3 months. Any scars, hyperpigmentation, hypopigmentation, recurrences shall be documented. Assessment of improvement for efficacy of therapy will be done by serial photographs and measurement of the lesion size along two dimensions at each visit (0, 3, 6, 9 and 12 weeks) and 3 months after the last session for final follow up. Parameters studied shall include age, sex, duration of the disease, number of lesions, clinical morphology of lesions, associated medical conditions, other associated xanthomas.  

 
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