| CTRI Number |
CTRI/2022/08/045104 [Registered on: 31/08/2022] Trial Registered Prospectively |
| Last Modified On: |
16/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of Chewable Gummies for Fine Line/Wrinkles, Hyperpigmentary Spots and Under Eyes Dark Circles. |
|
Scientific Title of Study
|
An Open Label, Single-Arm, Clinical Study to Evaluate Efficacy and Safety of Chewable Gummies in Healthy Adult Subjects with Fine Line/Wrinkles, Hyperpigmentary Spots and Under Eyes Dark Circles. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B02405; Version: 01, Dated 03 Aug 22. |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
917966219549 |
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
917966219549 |
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director - Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
917966219549 |
| Email |
ssethi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India |
|
|
Primary Sponsor
|
| Name |
Ikaria Wellness Pvt Ltd |
| Address |
412-B, The Capital,
Bandra Kurla Complex,
Mumbai – 400051
Maharashtra |
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
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 Parth Joshi |
Cliantha Research |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT |
8000085049
917966219549
pjoshi@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with fine line/wrinkles, hyperpigmentary spots and under eyes dark circles will be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Nyumi Radiant Skin Gummies |
Simply chew and swallow 2 gummies together after dinner for 75 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject has a fine line/wrinkles score of “2†(Few number of discreet fine lines) or greater surrounding the crow’s feet area as per Physician Global Assessment (PGA).
2.Subject has at least 2 hyperpigmentary spots on the face.
3.Subjects with Grade 2 and Grade 3 under eyes dark circles as determined by 6-point grading scale. |
|
| ExclusionCriteria |
| Details |
1.Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.
2.Subjects with any pigmentary disorder including Freckles and melasma.
3.Subject having excessive hair, moles, open wounds, cuts, abrasions, irritation symptoms, tattoos, scars, sunburn or any dermatological condition on the test site(s) that can interfere with the reading.
4.Subjects who are receiving topical or systemic treatments. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of fine line/wrinkles, skin dryness, coarse wrinkling/lines, laxity by Physician Global Assessment (PGA) using Griffiths Scale by Dermatologist |
Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Fine wrinkling, Coarse wrinkling, laxity using Severity Scoring by Dermatologist |
Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days) |
| Assessment of skin pigment using 9-point scale by Dermatologist |
Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days). |
| Assessment of under-eyes dark circles using 6-point grading scale by Dermatologist |
Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days). |
| Assessment of skin pigmentation using Mexameter® MX 18 |
Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days). |
| Assessment of uneven skin tone using Felix Von Luschan Skin colour chart |
Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days). |
| Assessment of Skin radiance using Modified Griffiths Scale by Dermatologist |
Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days). |
| Assessment of Skin Moisturization using Corneometer® CM 825 / MoistureMeterSC |
Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days). |
| Assessment of Skin gloss using Skin-Glossymeter GL 200 |
Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days). |
| Assessment of Skin firmness using Cutometer dual MPA 580 |
Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days). |
| Assessment of wrinkles of crow’s feet area, pigmentation, skin texture and under-eyes dark circles using 3D analysis system |
Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days). |
| Subject Satisfaction Questionnaire |
Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days). |
| Product Response Index (Perception about Product) |
Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days). |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2022 |
| Date of Study Completion (India) |
28/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="17" |
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 an open
label, single arm, clinical study to evaluate efficacy and safety of chewable
gummies in healthy adult subjects with fine line/wrinkles, hyperpigmentary
spots and under eyes dark circles.
The potential
subjects will be screened as per the inclusion and exclusion criteria only
after obtaining written informed consent from the subjects.
Study will consist of total 05 visits.
Visit 01: Screening Visit (Within 30 days prior to Day
01)
Visit 02: Enrollment Visit (Day 01)
Visit 03: Evaluation Phase (Day 25 ± 02 Days)
Visit 04: Evaluation Phase (Day 50 ± 02 Days)
Visit 05:
Evaluation Phase and End of Study (Day 75 ± 02 Days) |