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CTRI Number  CTRI/2025/03/082200 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   CHEMICAL PEELS FOR MACULAR AMYLOIDOSIS: A STUDY OF 15% TRICHLOROACETIC ACID PEEL VERSUS 35% GLYCOLIC ACID PEEL.  
Scientific Title of Study   A RANDOMISED CONTROL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 15% TRICHLOROACETIC ACID PEEL VERSUS 35% GLYCOLIC ACID PEEL IN PATIENTS WITH CUTANEOUS MACULAR AMYLOIDOSIS. 
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 RACHANA DOLLI 
Designation  POSTGRADUATE STUDENT 
Affiliation  BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU, KARNATAKA. 
Address  DEPARTMENT OF DVL, B BLOCK, 1ST FLOOR, VICTORIA HOSPITAL, K R MARKET, KALASIPALYAM, BENGALURU, KARNATAKA.

Bangalore
KARNATAKA
560002
India 
Phone  9740625696  
Fax  560002  
Email  dollirachana123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SHILPA K 
Designation  PROFESSOR AND HOD 
Affiliation  BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU, KARNATAKA. 
Address  DEPARTMENT OF DVL, B BLOCK, 1ST FLOOR, VICTORIA HOSPITAL, K R MARKET, KALASIPALYA, BENGALURU, KARNATAKA.

Bangalore
KARNATAKA
560002
India 
Phone  9886553646  
Fax  560002  
Email  shilpakvinod1980@gmai.com  
 
Details of Contact Person
Public Query  
Name  DR SHILPA K 
Designation  PROFESSOR AND HOD 
Affiliation  BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU, KARNATAKA. 
Address  DEPARTMENT OF DVL, B BLOCK, 1ST FLOOR, VICTORIA HOSPITAL, K R MARKET, KALASIPALYA, BENGALURU, KARNATAKA.

Bangalore
KARNATAKA
560002
India 
Phone  9886553646  
Fax  560002  
Email  shilpakvinod1980@gmai.com  
 
Source of Monetary or Material Support  
DR RACHANA DOLLI, DERMATOLOGY VENEREOLOGY AND LEPROLOGY RESIDENT, DEPARTMENT OF DERMATOLOGY VENEREOLOGY AND LEPROLOGY, B BLOCK, 1ST FLOOR, VICTORIA HOSPITAL, K R MARKET, BENGALURU-560002. KARNATAKA, INDIA. 
 
Primary Sponsor  
Name  DR RACHANA DOLLI 
Address  DR RACHANA DOLLI, DVL RESIDENT, DEPARTMENT OF DVL, B BLOCK, 1ST FLOOR, VICTORIA HOSPITAL, K R MARKET, BENGALURU 560002. KARNATAKA, INDIA. 
Type of Sponsor  Other [DR RACHANA DOLLI] 
 
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 RACHANA DOLLI  VICTORIA HOSPITAL  B BLOCK, 1ST FLOOR, ROOM NO 51, DEPARTMENT OF DVL, VICTORIA HOSPITAL, K R MARKET, BENGALURU 560002.
Bangalore
KARNATAKA 		 9740625696

dollirachana123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L818||Other specified disorders of pigmentation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  15% TRICHLOROACETIC ACID CHEMICAL PEEL  15% TRICHLOROACETIC ACID IS SUPERFICIAL MEDIUM DEPTH PEEL, CAUSES PROTEIN COAGULATION AND NECROSIS, LEADING TO EPIDERMAL PEELING AND REGENERATION. 15% TRICHLOROACETIC ACID IS APPLIED ONCE IN 4 WEEKS FOR 16 WEEKS. 
Comparator Agent  35% GLYCOLIC ACID CHEMICAL PEEL  35% GLYCOLIC ACID IS AN ALPHA HYDROXY ACID, WHICH FACILITATES EPIDERMAL REMODELING WITH LESS NECROSIS AND INFLAMMATION. 35% GLYCOLIC ACID PEEL IS APPLIED ONCE IN 4 WEEKS FOR 16 WEEKS. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients willing to give informed consent
2. Adults aged 18-60 years.
3. Diagnosed with primary cutaneous macular amyloidosis.
4. No prior treatment with TCA or GA peels.
5. Willing to comply with the follow-up schedule.
 
 
ExclusionCriteria 
Details  1.Pregnant or lactating women.
2.History of hypersensitivity to TCA or GA.
3.Presence of other active skin diseases or infections at the site.
4.Use of systemic retinoids within the past 6 months.
5.History of keloid or hypertrophic scar formation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
IMPROVEMENT IN THE PIGMENTATION OF SKIN.
IMPROVEMENT IN THE SYMPTOMS LIKE PRURITIS. 		 AT 4WEEKS, 8WEEKS, 12WEEKS AND 16WEEKS. 
 
Secondary Outcome  
Outcome  TimePoints 
TO RECORD THE ADVERSE REACTIONS TO CHEMICAL PEELS.
EVALUATE PATIENT SATISFACTION WITH TREATMENT. 		 ADVERSE REACTIONS TO CHEMICAL WILL BE RECORDED IMMEDIATELY AFTER PROCEDURE AND 2 DAYS POST PROCEDURE.
PATIENT SATISFACTION WITH THE TREATMENT WILL BE RECORED AT 16 WEEKS.
 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   27/03/2025 
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="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 - NO
Brief Summary  

After obtaining approval and clearance from the institutional ethics committee, the patients fulfilling the inclusion criteria will be enrolled for the study after obtaining informed consent.

A detailed clinical history will be taken in terms of demographic data, age, sex, occupation, presenting complaints, past history, treatment history, family history duration of skin lesions, course and progression of disease and clinical examination findings will be recorded in the case record form Appropriate photographs will be taken with informed consent.

After detailed history taking and thorough clinical examination, the patients illness will be scored with Color score, Visual Analogue Score (VAS), Physician Global Assessment Scale (PGA) & subjective grade.

 Patients diagnosed with Macular amyloidosis will be allocated into two study groups of 24 each randomized in 1:1 ratio using computer random sequence generator.

  1. Group A patients will be treated with 15% TCA peel. Prepeel priming will be done with GA cream 12% and physical sunscreen for 2 weeks. Test patch with 50% TCA behind the ear will be done in every patient 2weeks prior to peeling. The involved area will be degreased with 70% alcohol and TCA 15% will be applied by cotton bud. After a contact period of 3-5 minutes neutralisation will be done with normal saline. If the patient develops frosting early, it will be neutralized immediately.
  2. Group B patients will be treated with 35% GA peel. priming will be done with GA cream 12% and physical sunscreen for 2 weeks. involved area will be degreased with 70% alcohol and GA 35% will be applied by cotton bud. After a contact period of 3-5 minutes neutralisation will be done with sodium bicarbonate. If the patient develops erythema early, it will be neutralized immediately.

 

All groups will receive the treatment and patients’ illness will be reassessed with complete physical examination, Color score, Visual Analogue Score (VAS) ,Physician Global Assessment Scale (PGA) & subjective grade will be assessed at 4 weeks, 8 weeks, 12 weeks & 16 weeks follow up along with simultaneous serial digital photographs and recording of side effects if any.

Common side effects of TCA 15% and GA 35% are erythema, post inflammatory hyper/hypo pigmentation, burning sensation.

 
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