| CTRI Number |
CTRI/2025/05/087032 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| 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
|
Clinical Study to evaluate the safety and sfficacy of Nixoderm Tin in treating acne vulgaris in adults. |
|
Scientific Title of Study
|
A prospective, randomized, double blind, two arms, comparative clinical study to evaluate the safety and efficacy of Nixoderm tin in the management of acne vulgaris in adult subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/NTN/PB/2024 Version : 1.0 Date: 05th 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 Anupama mp |
The Oxford Medical College ,Hospital & Research Centre |
Department of Dermatology, Yadavanahalli, Attibele, Behind the La Classic Hotel,
Bangalore-562107.
Bangalore
KARNATAKA |
7702185084
DRANUPAMA.MP@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: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nixoderm tin |
Product to be applied twice a day at the site of acnes & blemishes,duration 30 days
Dosage form: Cream (Topical application) |
| Comparator Agent |
Placebo |
Product to be applied twice a day at the site of acnes & blemishes,duration 30 days
Dosage form: Cream (Topical application) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged between 18-65 years
2. Both male and female
3. Participants diagnosed with acne vulgaris on face with mild to moderate severity
4. Willing to give Informed Consent.
5. Willing to complete the study assessments/questionnaires.
6. Willing to avoid usage of his/her own skin care products for at least one week
before the commencement and during this study. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy or breast feeding.
2. Participants with history of hypersensitivity to skin care products.
3. Participants with mild to severe anaphylaxis reaction.
4. Participants with pre-existing severe systemic disease necessitating long
term medication.
5. Participants with any other concomitant skin diseases such as psoriasis, eczema
etc.
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:
• Acne quality of life index
questionnaire (AQOLI) questionnaire
• Sebumeter
• Global Acne Grading System (GAGS) |
Day 0,Day 7,Day 15,Day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dermatological Assessments |
Day 7,Day 15,Day 30. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/05/2025 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Acne vulgaris is a common cutaneous inflammatory disorder of the pilosebaceous unit, which runs a chronic course. The condition commonly manifests with papules, pustules, or nodules primarily on the face, although it can also affect the upper arms, trunk, and back. The pathogenesis of acne vulgaris involves the interaction of multiple factors that ultimately lead to the formation of its primary lesion, which is known as "comedo". Although acne vulgaris is commonly observed among adolescents, it is not restricted to this age group and can affect individuals of various ages. The severity of this condition can vary, ranging from a mild presentation with only a few comedones to more severe forms characterized by disfiguring inflammatory manifestations, which can lead to hyperpigmentation, scarring, and adverse psychological effects.Acne vulgaris is commonly observed in adolescents and young adults. Its prevalence rates are estimated to range from 35% to over 90% among adolescents. The natural course of this disease can commence as early as ages 7-12 (preadolescent acne) and resolve by the third decade of an individual’s life. However, there are instances where acne can persist into adulthood or even develop for the first time during adulthood. |