| CTRI Number |
CTRI/2024/01/061774 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of 24-hours moisturization potential of Avimee moisturizing lotion |
|
Scientific Title of Study
|
A Clinical Study to evaluate the 24-hours moisturization potential of Avimee Padmini moisturizing lotion. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT152 Version 1.0 dated 18 Dec 2023 |
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
|
| Avimee Herbal Pvt. Ltd. 422/2 F Building, GIDC Pandesara, Surat 394221 Gujrat |
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India |
|
|
Primary Sponsor
|
| Name |
Avimee Herbal Pvt. Ltd. |
| Address |
422 by 2 F Building, GIDC Pandesara, Surat 394221 Gujrat |
| 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 |
1st Floor room 3, Skin testing lab ,CCFT laboratories, AR multispecialty hospital and research center, Delhi Road Meerut Meerut Uttar Pradesh 250002 India Meerut UTTAR PRADESH 250002 Meerut UTTAR PRADESH
Meerut
UTTAR PRADESH
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: Avimee Padmini moisturizing lotion |
Dose: Gently massage approx. 1 drop of moisturizing lotion over one block as assigned (forearm) Route of Administration: Topical Duration: 24 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Gender: Male or Female 18 to 50
2. Subjects willing to give written informed consent
3. Women of childbearing potential must have a negative urine pregnancy test prior to study entry.
4. Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
5. Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
2. Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
3. Have open sores or open lesions in the treatment area.
4. Have any condition that, in the opinion of the investigator, would confound the safety and or efficacy assessments of the product.
5. Have participated in any interventional clinical trial in the previous 90 days.
6. Have a known sensitivity to any of the constituents of the test product
7. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
8. Have not skin related issues |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Moisture |
T0min, T+30 mins, T+ 2 hours, T+4 hours, T+ 6 hours, T+8 hours , T+ 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/01/2024 |
| 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="0"
Days="10" |
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
|
The below product would be tested as per the guideline IS4011 for dermal safety assessment.1. Padmini Moisturising Lotion. Test Product- Avimee Padmini Moisturizing lotion
Dose: Gently massage approx. 1 drop of Moisturizing lotion over one block as assigned (forearm) Route of Administration: Topical Duration: 24 hour
|