| CTRI Number |
CTRI/2023/06/053620 [Registered on: 07/06/2023] Trial Registered Prospectively |
| Last Modified On: |
25/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety Efficacy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the safety & efficacy of test product in Healthy Female subjects |
|
Scientific Title of Study
|
Clinical Study to Assess Safety, Efficacy, & Short-Term Consumer
Benefits of Facial Clay Mask in Healthy Female Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB230010-DE Version No. 01 (Final), 23 May 23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382421, Gujarat – India
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 - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382421, Gujarat – India
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 – 382421, Gujarat – India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| DPKA Universal Consumer Venture Private Limited
B-3002, Beau Monde
New Prabhadevi Road
Prabhadevi, Mumbai 400025, India |
|
|
Primary Sponsor
|
| Name |
DPKA Universal Consumer Venture Private Limited |
| Address |
B-3002, Beau Monde New Prabhadevi Road Prabhadevi, Mumbai 400025, India |
| Type of Sponsor |
Other [FMCG] |
|
|
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 |
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382421, Gujarat – India
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 Human Adult Females aged 21 to 50 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clay Mask |
Route of Administration: Topical
Mode of Usage:
Step 1 Cleanse: Wash your face with warm water and clean with
standard cleanser.
Step 2 Apply the mask: Take 4-5g of the product and apply the paste
with your fingertips, covering all of the face except the skin around
your eyes.
Step 3: Keep the paste for 20-25 minutes and then rinse with warm
water. Pat dry.
Duration: 3 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1) Age: 21 to 50 years (both inclusive) old at the time of consent.
2) Sex: Healthy human non-pregnant/non-lactating females.
3) Frequent users of international brands.
4) Females of childbearing potential must have a self-reported negative urine pregnancy test.
5) Subjects are generally in good general health as determined from recent medical history.
6) The subject is willing and able to follow the study directions, participate in the study,
returning for all specified visits.
7) The subject must be able to understand and provide written informed consent to participate
in the study. |
|
| ExclusionCriteria |
| Details |
Subjects must not be enrolled in the study if they meet any one of the following criteria:
1) Subject with known allergy or sensitization to cosmetic products.
2) The subject has clinically significant skin disease, which may contraindicate participation,
including psoriasis, eczema, Skin cancer or other skin pathology.
3) Medication which may affect skin response and/or past medical history.
4) Individuals with active (flaring) disease or chronic skin allergies (atopic dermatitis/eczema)
or those who have recently undergone treatment for skin cancer (within the last 12 months)
in the area of testing on the forehead, nose and the cheeks.
5) Female volunteers who have started a new hormonal birth control agent or switched to a
hormonal birth control agent within the past 60 days.
6) Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or
plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin,
dermal fillers, collagen or other similar cosmetic procedure.
7) Individuals who are currently using or during the past 14 days have used a retinoid such as
tretinoin, adapalene, or retinol containing agents or a hydroquinone containing agent.
8) Individuals who have used mineral clay masks on their face within the last 14 days.
9) Individuals who have been on any topical prescribed medications for the past 2 weeks.
10) An individual who has a medical condition or is taking or has taken a medication which, in
the Investigator’s judgment, makes the subject ineligible or places the subject at undue
risk.
11) Participation in other clinical studies simultaneously. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in skin hydration
2. Change in Skin Radiance
3. Change in Sebum Secretion
4. Change in number of pores, visible pores area, & clogged pores
5. Improvement in visible pores area |
From Baseline to Day 01 & Day 03 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in facial Photographs |
From Baseline to Day 01 |
To evaluate the product effectiveness in terms of subject response
index |
From Baseline to Day 01 & Day 03 |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2023 |
| Date of Study Completion (India) |
22/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is clinical and consumer study to assess safety, efficacy, and shortterm consumer benefits of clay- mask in healthy female subjects. The rationale of the product testing is to evaluate the effectiveness of the clay mask in terms of sebum reduction, improvement in skin texture and tone while maintaining the skin hydration. The acceptability of the clay mask will also be determined by self-evaluation questionnaires. The expected study duration of this study will be a maximum of 03 days from enrolment |