| CTRI Number |
CTRI/2022/12/048265 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
31/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [FMCG - Facial Beauty Oil] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to check the Safety and Efficacy of Vasu Facial Beauty Oil in Healthy Adult Human Subjects. |
|
Scientific Title of Study
|
A Proof-of-Concept, Safety and Efficacy Study of Vasu Facial Beauty Oil in Healthy Adult Human Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB220033-VH, Protocol Version No. 01 (Final), 30Nov2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India Gandhinagar
GUJARAT
Gandhinagar
GUJARAT
382421
India |
| Phone |
91-99013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India Gandhinagar
GUJARAT
GUJARAT
382421
India |
| Phone |
91-99013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director - Operations |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India Gandhinagar
GUJARAT
Gandhinagar
GUJARAT
382421
India |
| Phone |
91-9909013236 |
| Fax |
|
| Email |
maheshvari@novoboliss.in |
|
|
Source of Monetary or Material Support
|
| Vasu Healthcare Private Limited |
|
|
Primary Sponsor
|
| Name |
Vasu Healthcare Private Limited |
| Address |
Office at 967-4 GIDC, Makarpura,
Vadodara – 390 010, Gujarat, India
|
| Type of Sponsor |
Other [FMCG Manufacturing] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| None |
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 Private Limited |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India
Department - Clinical Trials
Gandhinagar
GUJARAT |
91-9909013286
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 |
Having crow feet wrinkles, uneven textured, uneven skin tone, with dry to normal skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
Not Applicable |
| Intervention |
Vasu Facial Beauty Oil |
Step 1- Wash face, pat dry
Step 2- Gently massage 2-3 drops of Vasu Facial Beauty Oil over the face and neck till it gets absorbed and keep it overnight.
Step 3- Use it for 60 days
Frequency- Daily before going to bed.
Route of Administration- Topical
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Age: 25 to 55 years (both inclusive) at the time of consent.
2)Sex: Healthy males and non-pregnant/non-lactating females.
3)Females of childbearing potential must have a self-reported negative pregnancy test.
4)Subject are generally in good health.
5)Subject has a score of at least “mild skin aging†based on PGA at screening visit.
6)Subject with Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
7)Subjects with wrinkles at Crow’s feet area.
8)Subjects with uneven texture skin, uneven skin tone, with dry to normal skin only.
9)Subjects with dry skin having ≤ 40% value as evaluated by MoisturemeterEpiD.
10)Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
11)Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
12)Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
13)Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
14)If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
15)If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
16)Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.
17)Subjects are willing to give written informed consent and are willing to follow the study procedure.
18)Subjects who have used other marketed products for hair thinning in the past.
19)Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for thin hair, or hair products other than the test product for the entire duration of the study.
20)Willing to use test product throughout the study period.
|
|
| ExclusionCriteria |
| Details |
1)Subject has a history of allergy or sensitivity to the test treatment ingredients like Kumkumadi tailam, avocado, argan, lavender, rapeseed oil and others etc.
2)Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
3)Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
4)Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
5)Subject is currently pregnant/breastfeeding.
6)Subject has a history of alcohol or drug addiction.
7)Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
8)Pregnant or breastfeeding or planning to become pregnant during the study period.
9)History of chronic illness which may influence the cutaneous state.
10)Subjects participating in other similar cosmetics, devices or therapeutic trials or skin care products within the last four weeks.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of the test product in reducing the facial wrinkles and fine lines of Crow’s feet area |
On Day 01 Before Product usage and Day 30, Day 60 after test product usage |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of the test product in terms of change in Physician Global Assessment (PGA) scoring using Griffiths scale – Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness |
On Day 01 Before Product usage and Day 30, Day 60 after test product usage |
| To assess the effect of the test product in terms of change in Glogau Skin Age |
On Day 01 Before Product usage and Day 30, Day 60 after test product usage |
| To assess the effect of the test product in terms of instant change in skin pigmentation |
On Day 01 Before Product usage and Day 30, Day 60 after test product usage |
| To assess the effect of the test product in terms of change in skin colour i.e. L- a- b- and ITA angle |
On Day 01 Before Product usage and Day 30, Day 60 after test product usage |
| To assess the effect of the test product in improvement in Skin elasticity |
On Day 01 Before Product usage and Day 30, Day 60 after test product usage |
| To assess the effect of the test product in improvement in Skin hydration |
On Day 01 Before Product usage and Day 30, Day 60 after test product usage |
| To assess the effect of the test product in improvement in Skin barrier function in terms of a decrease in Transepidermal Water Loss (TEWL) |
On Day 01 Before Product usage and Day 30, Day 60 after test product usage |
| To assess the effect of test product in terms of change in Skin brightness and skin pigmentation reduction |
On Day 01 Before Product usage and Day 30, Day 60 after test product usage |
| To assess the occurrence of Acne lesions in terms of IGA Scoring for Acne Severity |
On Day 01 Before Product usage and Day 30, Day 60 after test product usage |
| Change in a photograph from “before test product usage†and “after test product usage†|
On Day 01 Before Product usage and Day 30, Day 60 after test product usage |
| To assess the effect of the test product in terms of treatment perception regarding the test product’s effect on skin firmness, appearance, radiance, the occurrence of acne breakouts, glowing skin tone, blemishes and dark skin patches removal |
On Day 01 Before Product usage and Day 30, Day 60 after test product usage |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/12/2022 |
| Date of Study Completion (India) |
06/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Upon completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an open-label, single-arm, single-centre, proof-of-concept, exploratory, safety and efficacy, clinical study of a Vasu Facial Beauty Oil in healthy adult human subjects.Considering proof of concept study, a sufficient number [maximum of 32 subjects (25 females and 7 males)] of adult subjects will be recruited/enrolled to ensure a total of 30 subjects complete the study. The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The adult female/male subjects will be instructed to visit the facility as per the below visits. ·Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluations ·Visit 02 (Day 30 i.e. week 4): Treatment Period, Evaluations ·Visit 03 (Day 60 i.e. week 8): Evaluations, End of Study Visit Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by the recruiting department prior to the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up or any use any hair product on the study visit day. Assessment of efficacy parameters before test product usage will be done on day 1, and after test product usage will be done on day 30, and day 60 as listed-below. - Skin Elasticity: Derma Lab Combo or Cutometer Dual MPA 580 (Right Cheek) - MoistureMeterEPiD: Skin Hydration (Right cheek) - Vapometer: Skin Barrier function - Transepidermal water loss (Right cheek) - Skin Colorimeter CL 400: Right cheek skin colour evenness L*, a* b*, ITA Angle - Visioscan (C+K Instrument): Crow’s feet area wrinkles, fine lines, skin texture – roughness, dryness, wrinkles, smoothness - PGA scoring using Griffiths scale – Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness - Glogau Skin Age - Skin Pigmentation Scoring - Occurrence of Acne - IGA score for assessment of Acne. - Digital Photographs: Facial photographs Before test treatment usage and after test treatment usage using DermoPrime Skin/Hair Analyzer. - Subjective Product Perception Assessment regarding the test product’s effect on skin firmness, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes and dark skin patches removal etc. There will be 03 visits during the conduct of the study. The duration of the study will be 60 Days (+2 days) from enrolment. |