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CTRI Number  CTRI/2024/11/076566 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 06/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   CLINICOEPIDEMIOLOGICAL AND HISTOPATHOLOGICAL FEATURES OF EPIDERMAL KERATINOCYTIC NEOPLASMS AND PHOTODYNAMIC THERAPY  
Scientific Title of Study   A STUDY OF THE CLINICOEPIDEMIOLOGICAL AND HISTOPATHOLOGICAL FEATURES OF EPIDERMAL KERATINOCYTIC NEOPLASMS WITH THE ROLE OF PHOTODYNAMIC THERAPY IN TREATMENT AT A TERTIARY CARE CENTRE 
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 Shriya Singh 
Designation  Junior Resident -1st year  
Affiliation  Grant Government Medical College and Sir JJ hospital  
Address  Grant goverment Medical College Byculla . Mumbai . Department of Dermatology, venerology and leprosy . OPD building . OPD 42
Byculla , Mumbai.
Mumbai
MAHARASHTRA
400008
India 
Phone  8898498215  
Fax    
Email  singhshriya007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Kumar  
Designation  Professor  
Affiliation  Grant Medical College Mumbai  
Address  Grant Medical College , Byculla Mumbai . Department of dermatology, venerology and leprosy. OPD building. OPD 42

Mumbai
MAHARASHTRA
400008
India 
Phone  9967537787  
Fax    
Email  rkderm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Kumar  
Designation  Professor  
Affiliation  Grant Medical College Mumbai  
Address  Grant Medical College . Byculla. Mumbai Department of dermatology venerology and leprosy. OPD building . OPD 42

Mumbai
MAHARASHTRA
400008
India 
Phone  9967537787  
Fax    
Email  rkderm@gmail.com  
 
Source of Monetary or Material Support  
Grant goverment Medical College Byculla , Mumbai 400008. Maharashtra India  
 
Primary Sponsor  
Name  Shriya singh  
Address  A/7 airlines. Chakala Andheri East Mumbai 400093. Maharashtra. 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 Shriya Singh  Grant Goverment Medical College Mumbai  Department of Dermatology, Venerology and Leprosy. OPD building. OPD 42
Mumbai
MAHARASHTRA 		 8898498215

singhshriya007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, GGMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C449||Other and unspecified malignant neoplasm of skin, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable   Not Applicable  
Intervention  Safety and efficacy of photodynamic therapy in epidermal keratinocytic tumors   Patient having clinically suspected lesion will be advised biopsy , those having histopathologic features will be included in primary objective. Patients fulfilling inclusion criteria will be taken for treatment with photodynamic therapy . They will be informed about all the details of the procedure and an informed written consent will be taken along with pre-procedure photography of the lesion for documentation Patient will be taken for the procedure starting by debulking of the lesion wherever necessary with either CO2 laser , currettage or shave excision for better absorption of sensitizer. Sensitizer will be applied at target lesion and covered with non absorbable material and above it with aluminium foil to protect from light. The photosensitizer which is 5-Aminolevulanic acid or methylaminolevulanic acid is applied for 3 hours after which we can do the further procedure The target lesion area is irradiated with Red light of 600-720nm at a distance of 32cm from the target lesion for a period of 10-15 mins from source machine with an irradiance of 10 – 200mW/cm2 and the dose will be 100-200J/cm2 Two sessions will be done at 2-4 weeks interval depending on the response and side effects. Post procedure management will be done by advising sun protection and anti inflammatory drugs to the patient. Clinical photography will be done at each follow up with noting the parameters mentioned in case record form Assessment of the efficacy and safety of the procedure in the treatment of epidermal keratinocytic neoplasms .  
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  For primary objective of clinicoepidemiologic and histopathologic study of epidermal keratinocytic neoplasms- people of any age and gender having clinically suspected tumors For secondary objective of treatment with photodynamic therapy willing for procedure having biopsy proven epidermal keratinocytic neoplasms. 
 
ExclusionCriteria 
Details  For primary objective - not willing for biopsy or photography
For secondary objective - pregnant and lactating women, less than 18yrs age , people having cardiac disease, porphyria , keloidal tendency, photosensitivity, tumor more than 3cm size ,  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Study of clinicoepidemiologic and histopathologic features of epidermal keratinocytic neoplasms .
The patients age , gender , occupation, history clinical features , types of lesions , sytemic examination  		 Patient will be advised biopsy at presentation and followed up with histopathology report Primary objective is just observational and does not require further follow up unless the patient is taken for secondary objective which is photodynamic therapy  
 
Secondary Outcome  
Outcome  TimePoints 
Safety and efficacy of photodynamic therapy in treatment of epidermal keratinocytic tumors will be seen by doing photodynamic therapy on patient filling inclusion criteria.
A photosensitiser will be applied on the lesion and kept for 3hrs after which the area will be irradiated by light of 630nm from the photodynamic therapy machine  		 2 sessions will be done at 2-4weeks interval and results will be noted with the side effects  
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   01/12/2024 
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="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

  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 (Others) -  Article or publication

  6. For how long will this data be available start date provided 08-01-2025 and end date provided 05-09-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Patient presenting with complaints of suspected tumors like lesion will be advised biopsy and clinical photography will be done.  The histopathology report of biopsy will be studied and patients having epidermal keratinocytic tumors like seborrheic keratosis, basal cell carcinoma, squamous cell carcinoma, actinic keratosis, bowenoid papulosis , bowens disease etc will be taken for primary objective which is study of clinicoepidemiologic and histopathological features of epidermal keratinocytic tumors. Patients fulfilling inclusion criteria for secondary objective will be advised photodynamic therapy . The lesion depending on size or location will be either directly or first reduced with a CO2 laser or by shave excision and then photosensitiser will be applied which is 5-aminolevulanic acid and kept covered for 3hrs . Then the area will be irradiated by 630nm light by the photodynamic therapy.  Post procedure care will be done for the patient . Patient will be followed up and 2nd session will be done at 2-4 weeks interval depending on tresponse and side effects . After 2 session the result will be evaluated in terms of terms in size of lesion and the side effects if any.   
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