| CTRI Number |
CTRI/2024/11/077103 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Patch test on healthy human subjects |
|
Scientific Title of Study
|
Evaluation of dermatological safety and hypo-allergenicity of investigational products by
Human Repeat Insult Patch Test (HRIPT) on healthy human volunteers as per IS
4011:2018 |
| 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 Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd
Plot No:99/A, 8th Main Road,
3rd Phase, Peenya Industrial Area, Bengaluru, Karnataka 560058.
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,
3rd Phase, Peenya Industrial Area, Bengaluru, Karnataka 560058.
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,
3rd Phase, Peenya Industrial Area, Bengaluru, Karnataka 560058.
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| SC Johnson & Son Nigeria Ltd |
|
|
Primary Sponsor
|
| Name |
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 Madan Mohan N T |
Sri Venkateshwara Hospital, |
Site No 1, SKY HEIGHTS, 2, Sarjapura-
Attibele Road, Bangalore,
Karnataka-562107.
Bangalore
KARNATAKA |
8065733349
drmadan1969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Isotonic Saline |
40 µl of investigational product(without dilution) was applied on the precut filter paper placedinside the allotted Derma proof Aluminium Finn chamber prefixed to a scanpore tape. Patch was applied on upper arm or back. Duration: 40 days (patch application will be for 3 weeks, a two-week washout period, immediately followed by re-challenge and then observation for 24hrs, 48 hrs and 72 hrs after patch removal) |
| Intervention |
Nixoderm Tin |
40 µl of investigational product(without dilution) was applied on the precut filter paper placedinside the allotted Derma proof Aluminium Finn chamber prefixed to a scanpore tape.
Patch was applied on upper arm or back.
Duration: 40 days (patch application will be for 3 weeks, a two-week washout period, immediately followed by re-challenge and then observation for 24hrs, 48 hrs and 72 hrs after patch removal)
|
| Comparator Agent |
Sodium Lauryl Sulphate |
40 µl of investigational product(without dilution) was applied on the precut filter paper placedinside the allotted Derma proof Aluminium Finn chamber prefixed to a scanpore tape. Patch was applied on upper arm or back. Duration: 40 days (patch application will be for 3 weeks, a two-week washout period, immediately followed by re-challenge and then observation for 24hrs, 48 hrs and 72 hrs after patch removal) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Voluntary men/women between 18 and 65 years.
2. Photo type III to V.
3. Having apparently healthy skin on test area
4. For whom the investigator considers that the compliance will be correct.
5. Cooperating, informed of the need and duration of the examinations and
ready to comply with protocol procedures.
6. Having signed a Consent Form.
7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
8. Willingness to avoid excessive water contact (for example swimming) or
activity which causes excessive sweating (that is exercise, sauna…), during
the course of the study.
9. Should be able to read and write (in English, Hindi or local language).
10. Having valid proof of identity and age. |
|
| ExclusionCriteria |
| Details |
1. Pregnant/nursing mothers
2. Scars, excessive terminal hair or tattoo on the studied area.
3. Henna tattoo anywhere on the body (in case of studies involving hair
dyes).
4. Dermatological infection/pathology on the level of studied area.
5. Hypersensitivity, allergy antecedent (to any cosmetic product, raw
material or hair dye).
6. Any clinically significant systemic or cutaneous disease, which may
interfere with study treatment or procedures.
7. Chronic illness which may influence the outcome of the study.
8. Subjects on any medical treatment either systemic or topical which may
interfere with the performance of the study treatment (presently or in
the past 1 month).
9. Subject in an exclusion period or participating in another food, cosmetic
or therapeutic trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the irritation & or sensitization
potential of a test material.
2. In support of sensitive skin claims &
supporting evidence for hypo allergenicity claims
after repeated application under occlusive or
semi occlusive patches to the skin of human
subjects. |
Day 1 to Day 40. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence & rate of adverse events. |
Day 1 to Day 40 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
04/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Study will be conducted over a period of 40 days for each subject, there is first induction phase where patches will be applied on thrice a week basis for three weeks, a two-week washout period is called rest phase involves no application of any patch in order to develop sensitization to the test product, immediately followed by challenge phase and then observation for 24hrs, 48 hrs and 72 hrs after patch removal. |