| CTRI Number |
CTRI/2024/11/076446 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Wrinkle Repair, Barrier Support and Hydration Activity of Asaya Serum |
|
Scientific Title of Study
|
A Consumer Study to Check the Wrinkle Repair, Barrier Support and Hydration Activity of Asaya 5 percent Multi-Peptide Complex and Hyaluronic Acid Serum |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT 337 Version 1.0 dated 11 Sep 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
7078103723 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| Asaya, 2nd Floor, Alpha Building, Sigma Soft Tech Park, S-5A and 6-A, Varthur Kodi, Palm Meadows, Whitefield, Bengaluru, Karnataka 560066 |
| CCFT Laboratories, First floor, 135, Delhi Rd, besides Ramleela ground, New Punjabi Pura, Meerut, Uttar Pradesh 250002 |
|
|
Primary Sponsor
|
| Name |
Asaya |
| Address |
2nd Floor, Alpha Building, Sigma Soft Tech Park, S-5A and 6-A, Varthur Kodi, Palm Meadows, Whitefield, Bengaluru, Karnataka 560066 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
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 Robin Chugh |
CCFT laboratories |
First Floor, 135, Panjabipura, Besides Ramleela Ground, Delhi Road
Meerut
UTTAR PRADESH |
7078103723
robinderm25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product- 5% Multi-Peptide Complex & Hyaluronic Acid Serum |
Take 2-4 drops and massage in outward direction, Route of administration: Topical Frequency: twice a day, Duration: 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary man or women between 18 and 65 years.
2. Photo type III to V.
3. Having apparently healthy skin.
4. For whom the investigator considers that the compliance will be correct.
5. Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
6. Having signed a Consent Form.
7. Having valid proof of identity and age. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or nursing mothers
2.Dermatological infection or pathology on the level of studied area
3.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye)
4.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures
5.Chronic illness which may influence the outcome of the study
6.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)
7.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage change in users observed change in Wrinkle , Hydration |
at study end only (observation after 4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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
|
This is an observational, questionnaire based User test consumer study where the consumers would themselves evaluate the product efficacy after using the product for 4 weeks for its efficacy against Skin Hydration and Wrinkles Repair.
Below data would be taken only at the end of the study as a subjective survey. 1. reduction in Wrinkles 2. Improvement in Hydration 3. Reduced dullness
Done for 4 weeks on 100 healthy volunteers |