| CTRI Number |
CTRI/2023/12/060978 [Registered on: 29/12/2023] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Detergents] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial on detergent powder in healthy human volunteers |
|
Scientific Title of Study
|
A Randomized, Double blinded, Comparative study to evaluate the efficacy of dermal irritancy potential of detergents in healthy human volunteers. |
| Trial Acronym |
Hand Immersion |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/DP2/2023 Version Number: 1.0 Dated: 17 Oct 2023 |
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 |
Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, Karnataka
Bangalore
KARNATAKA
560058
India |
| Phone |
9880999297 |
| 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 |
Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, Karnataka
KARNATAKA
560058
India |
| Phone |
9880999297 |
| 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 |
Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, Karnataka
KARNATAKA
560058
India |
| Phone |
9880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| UNILEVER INDUSTRIES PRIVATE LIMITED
#64, WHITEFIELD MAIN ROAD
WHITEFIELD, PALM MEADOWS
BANGALORE-560066
KARNATAKA, INDIA
|
|
|
Primary Sponsor
|
| Name |
UNILEVER INDUSTRIES PRIVATE LIMITED |
| Address |
#64, WHITEFIELD MAIN ROAD WHITEFIELD, PALM MEADOWS BANGALORE-560066 KARNATAKA, INDIA |
| Type of Sponsor |
Other [Consumer goods company] |
|
|
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 |
Shetty’s Hospital |
Plot no, 11 & 12, 12th F Main Rd, Room no 2
Department of medicine Ground floor Kaveri Nagar,
Bommanahalli, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA |
8065733349
drmadan1969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shetty’s 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 |
| Intervention |
India SFXL QW detergent
powder 3
|
Dose:3grams/l dissolved in hard
water 24 French Hardness for
hand immersion. Duration: 3
Days |
| Comparator Agent |
India SFXL QW detergent
powder 4
|
Dose:3grams/l dissolved in hard
water 24 French Hardness for
hand immersion. Duration: 3
Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Adult Female volunteers between 18 and 45 years.
2. Photo type II to V (which includes sensitive skin type)
3. Having apparently healthy skin on test area.
4. No H/O any allergies to any food/ food ingredients.
5. For whom the investigator considers that the compliance will be correct.
6. Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
7. Having signed a Consent Form.
8. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
9. 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.
10. Should avoid using any type of moisturizing cream or soaps or oil or face wash during the study (14days).
11. Should be able to read and write (in English, Hindi or local language).
12. 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. Dermatological infection/pathology on the level of studied area.
4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
5. Any allergies to any food/ food ingredients
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. Using any type of Moisturizing cream or soaps or face wash or oil.
9. 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).
10. Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Comparison of Skin reaction scores (dryness and scales) between comparator and test products.
2. Comparison of Videoscopy between comparator and test products.
3. Comparison of TEWL between comparator and test products.
4. Comparison of Hydration level between comparator and test products.
|
Day 0 to Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence & rate of adverse events |
Day 0 to Day 7 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/01/2024 |
| Date of Study Completion (India) |
29/12/2023 |
| 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)
Modification(s)
|
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
|
After
obtaining the Ethics committee and CTRI approval subjects will be asked to
visit the site. In visit 1 subjects are advised not to use any type of
moisturizer during the course of the study. Also the subjects will be given a
soap for their regular use for our study which should be used for 14 days. Then
the Informed consent will be provided to the study volunteers, and after
obtaining their consent, the female subjects will be asked about their medical
history and the Investigator or his/her designee will conduct a physical
examination. Demographics and vital signs will be recorded. On 7th
day, that is considered as day 0, the subjects are asked to visit the site for
skin stripping and skin swabbing test. Then from day1 to day 3 subjects are
asked to visit the site regularly for the study purpose. They are asked to wash
their hands thoroughly with normal water, dry it and wait for 1 hour. After 1
hour, the instrumental analysis like Videoscopy, TEWL and Hydration will be
done. After organizing the seating arrangements of volunteers for hand
immersion in a convenient/comfortable manner, 50 percent of the volunteers in a
test immerse their left hand in the sample coded as ‘A’ and right hand in the
sample coded as ‘B’, the other 50 percent, vice versa. Each volunteer immerses
his/her respective hand up to the wrist in the solution with constant movement
of the fingers for agitating the liquid for 10 minutes. After each immersion,
the volunteers wash the hands thoroughly with normal water and gently wipe with
a lint Free tissue paper. After 1 hour, the efficacy assessments like
Videoscopy, TEWL, Hydration and dermatological assessments will be conducted.
On Day 4 and day 7 subjects are asked to visit the site. Only dermatological
Assessments, instrumental Assessments, skin swabbing and skin stripping will be
done. Day - 6: Study schedule explanation to the subjects, based on inclusion and
exclusion criteria, subjects enrolled after taking informed consent form.
Day 0: Skin swabbing
and skin Stripping
Day 1 – Dermatological
and Instrumental assessments before and after Hand immersion
Day 2 – Dermatological
and Instrumental assessments before and after Hand immersion
Day 3 – Dermatological
and Instrumental assessments before and after Hand immersion
Day 4 - Dermatological, Instrumental assessments,
skin swabbing and skin stripping
Day 7 – Dermatological, Instrumental assessments, skin
swabbing and skin stripping |