| CTRI Number |
CTRI/2024/04/064998 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the effect of the test product on healthy human subjects. |
|
Scientific Title of Study
|
Assessment of Moisturekinetic and Skin Barrier Repair Parameters of Test Product(s) in Healthy Adult Male and Female Subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB230049-CL_Final(1.0)_14Mar24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj.
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj.
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research private Limited |
| Address |
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj.
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Cipla Limited-
Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai-400013, India. |
|
|
Primary Sponsor
|
| Name |
Cipla Limited |
| Address |
Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai-400013, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
NovoBliss Research Pvt. Limited |
Clinical Trial Department
Office# A -
206, 2nd Floor,
Shaligram Lakeview
Business Complex, Nr.
Vaishnodevi Circle,
Khoraj
Gandhinagar
GUJARAT |
9909013286
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male and female having dry skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
No Product Application |
| Intervention |
Excela Lite Daily Skin Nourishing Lotion |
Marketed By: Cipla Limited
Test Product: Excela Lite Daily Skin Nourishing Lotion
Mode of usage: Apply the required amount of test product after washing.
Frequency: Twice a Day
Route of Administration: Topical
Total duration: 28 Days
Dosage form: Liquid
Dose: Required amount |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 18 to 55 years(both inclusive) at the time of consent.
2. Sex: Healthy male and non-pregnant/non-lactating female.
3. Females of childbearing potential must have a self-reported negative urine pregnancy test.
4. Subjects with skin hydration less than 40 percentage at application site though the instrumental assessment and as per the dermatologist ( for dry skin subjects)
5.Subject is in good general health as determined by the Investigator on the basis of medical history.
6.Subjects should be willing and able to follow the study protocol to participate in the study.
7.Subject must be able to understand and provide written informed consent to participate in the study.
8.Subject is willing to refrain from vigorous physical exercise during the study period.
9.Subjects is willing not to use any other marketed product on application site during the study visit.
|
|
| ExclusionCriteria |
| Details |
1.Subject has any known allergy to test product ingredient.
2.Presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
3.Participation in any similar clinical trial within the past 90 days.
4.Currently have any allergies or chronic allergies or sensitivities to soaps, shampoos, conditioners, or any other skin care products as well as fragrances.
5.Currently using any topical medications.
6.Consume any alcoholic beverages during the days of the study.
7.Pregnant or lactating females.
8.Self-reported Positive HIV test.
9.History of Hepatitis B or C virus self-reported.
10.Have any other condition or factor that the Investigator believes may affect interpretation of the results. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the effectiveness of the test product in terms of change in skin barrier repair using Tewameter TM Hex.
2.To assess the effectiveness of the test product in terms of change in skin hydration using MoisturemeterEpiD/ Corneometer CM 825.
3. To assess the effectiveness of the test product in terms of change in skin texture using MoisturemeterEpiD/ Corneometer CM 825.
4.To assess the effectiveness of the test product in terms of change in skin dryness, redness, smoothness, roughness, itchiness, and scaliness at application site by dermatologist and dermatologist trained evaluator. |
Baseline before application of the test product to after application at T0 (20 mins), T1 (01 hrs), and T2 (12 hrs) on Day 01, T24 hrs on Day 2, and 28 Days post usage. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the efficacy of the test product in terms of subjective product perception questionnaire using 9-point hedonic scale.
2. To assess the safety of the test product in terms of adverse events reported by subjects or assessed by the Investigator |
Baseline before application of the test product to after application at T0 (20 mins), T1 (01 hrs), and T2 (12 hrs) on Day 01, T24 hrs on Day 2, and 28 Days. |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/04/2024 |
| Date of Study Completion (India) |
30/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Evaluation of Moisturekinetic and skin barrier in healthy adult male and female subjects. A total of up to 26 healthy adult male and non-pregnant/non-lactating females with an age of 18-55 years will be enrolled to ensure a total 24 evaluable subjects complete the study. Visit 1(Day 01): Screening Phase Visit 2(day 02): Enrolment Phase, Test Product Usage, Evaluation Visit 3 (Day 03): 24 hours post application evaluation, test product usage period Visit 4 (Day 14): Telephonic follow-up Visit 4(Day 28): Evaluation, End of the study
|