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CTRI Number  CTRI/2025/04/085903 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Evaluating the safety and efficacy of Nixoderm Tin in the treatment of atopic dermatitis in adults. 
Scientific Title of Study   A prospective, randomized, double blind, two arm, comparative clinical study to evaluate the safety and efficacy of Nixoderm tin for treating atopic dermatitis in adult subjects.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CL/NTN/AD/2024 Version: 1.0 Date: 26th October 2024   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research services Pvt Ltd 
Address  Radiant Research services Pvt Ltd Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru - 560058, Karnataka, India

Bangalore
KARNATAKA
560058
India 
Phone  09880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research services Pvt Ltd 
Address  Radiant Research services Pvt Ltd Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru - 560058, Karnataka, India

Bangalore
KARNATAKA
560058
India 
Phone  09880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research services Pvt Ltd 
Address  Radiant Research services Pvt Ltd Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru - 560058, Karnataka, India

Bangalore
KARNATAKA
560058
India 
Phone  09880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Source of Monetary or Material Support  
M/s.SC Johnson & Son Nigeria Ltd 13/14 ABIMBOLA STREET, ISOLO LAGOS NIGERIA. 
 
Primary Sponsor  
Name  M/s.SC Johnson & Son Nigeria Ltd 
Address  13/14 ABIMBOLA STREET, ISOLO LAGOS NIGERIA.  
Type of Sponsor  Other [[Cosmetic Industry]] 
 
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 Sanjay Thejaswi R  The Oxford Medical College ,Hospital & Research Centre   Department of Dermatology,Yadavanahalli, Attibele, Behind the La Classic Hotel, Bangalore-562107.
Bangalore
KARNATAKA 
9844080603

rsanjaythejaswi@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Oxford Medical College Hospital & Research Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nixoderm Tin   Sufficient quantity of Nixoderm Tin to be applied twice day at the site of Atopic Dermatitis, duration 30 days  
Comparator Agent  Placebo  Sufficient quantity of Nixoderm Tin to be applied twice day at the site of Atopic Dermatitis, duration 30 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male and Female volunteers aged between 18-60 years.
2. Participants diagnosed with of mild to moderate atopic dermatitis.
3. Willing to give Informed Consent
4. Willing to complete the study assessments/questionnaires.
5. Willing to avoid usage of his/her own skin care products in controlling atopic
dermatitis for at least one week before the commencement and during this
study. 
 
ExclusionCriteria 
Details  1. Pregnancy or breast feeding.
2. Patients with inflammatory or infective skin conditions.
3. Patients with history of hypersensitivity to skin care products.
4. Patients with mild to severe anaphylaxis reaction.
5. Patients with pre-existing severe systemic disease necessitating long-term
medication.
6. Evidence of significant uncontrolled co-morbid disease which in the
investigators opinion would jeopardize patient participation.
7. History of cancer, including solid tumors, hematologic malignancies and
carcinoma in situ.
8. Participation in the current or previous clinical trial with any approved or
investigational products during the past 1 month. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Primary Outcomes:
1.Percentage reduction in atopic dermatitis from baseline visit to last visit
assessed by Atopic Dermatitis Severity Index (ADSI) and photographic
evaluation.
• Percentage reduction of erythema, edema and papulation would be assessed
through Eczema Area and Severity Index (EASI) from baseline to end of the
study.  
Day0,Day7,Day15,Day30. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcomes:
1.Change from baseline in the Dermatological assessment [All
visits]
2.Feedback Questionnaires from baseline to all visits

 
Day 7, Day 15, Day 30 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/05/2025 
Date of Study Completion (India) 14/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
Atopic dermatitis is the most common chronic inflammatory skin disease globally with huge socioeconomic implications, particularly in patients with moderate-to-severe disease. Atopic dermatitis commonly starts during the first year of life and affects over 200 million individuals worldwide, with estimated prevalence rates of up to 15–25% in children and 3–7% in adults. Some patients experience long-term resolution of their skin symptoms, whereas others have atopic dermatitis for their entire lives. The risk of persistence into adulthood is somewhat increased in individuals with later onset or a more severe atopic dermatitis course, but data differ greatly across studies. Despite an increased understanding of the pathogenesis of atopic dermatitis, there are no available biomarkers that can predict disease course. Although the traditional systemic therapeutics are broad-acting immunosuppressants with potentially deleterious long-term side-effects, novel, targeted agents have substantially broadened the therapeutic armamentarium. For decades, long-term disease control and maintenance were particularly challenging given that treatment options were limited to broad topical and systemic immunosuppressive agents.
 
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