| 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
|
|
|
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
|
|
|
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. |