| CTRI Number |
CTRI/2022/01/039292 [Registered on: 10/01/2022] Trial Registered Prospectively |
| Last Modified On: |
26/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [[Dermatological]] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In this study LactoSporin® would be compared with comparator for its effectiveness and
safety,on age related changes in the skin of healthy female Volunteers |
|
Scientific Title of Study
|
A randomized, double-blind, placebo controlled, monocentric study to evaluate the efficacy of the LactoSporin® on age related changes in the skin of healthy female participants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CW/104/LSP_AGNG/II/NOV/21 1.0 dated 03/Dec/2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Dermatologist |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore
Bangalore
KARNATAKA
560008
India
Bangalore
KARNATAKA
560008
India |
| Phone |
09844020353 |
| Fax |
|
| Email |
mukesh.ramnane@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpesh Shah |
| Designation |
Senior Vice President |
| Affiliation |
ClinWorld, a division of Sami-Sabinsa Group |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore.
Bangalore
KARNATAKA
560058
India
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
kalpesh@clinworld.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpesh Shah |
| Designation |
Senior Vice President |
| Affiliation |
ClinWorld, a division of Sami-Sabinsa Group |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore.
Bangalore
KARNATAKA
560058
India
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
kalpesh@clinworld.org |
|
|
Source of Monetary or Material Support
|
| Sami-Sabinsa Group Limited 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore,
Karnataka. 560058. |
|
|
Primary Sponsor
|
| Name |
SamiSabinsa Group Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore,
Karnataka, 560058. |
| Type of Sponsor |
Other [[Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements.]] |
|
|
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 Mukesh Ramnane |
MS Clinical Research Private Limited |
327/15/1st Main Road,
Cambridge Layout,
Ulsoor, Bangalore.
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
09844020353
mukesh.ramnane@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
age related changes in the skin of healthy female participants with Fitzpatrick skin types III to V |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LactoSporin® |
Approximately one (1) FTU for full face.
Twice a day for 10 weeks
In the morning before participants do their activity and night before bed.
|
| Comparator Agent |
Placebo |
Approximately one (1) FTU for full face. Twice a day for 10 weeks In the morning before participants do their activity and night before bed. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
•Female adult participants in general good health as determined from a recent medical history general physical examination, dermatological assessment.
•Participants in the age group of 35-65years (both ages inclusive).
•Subject with Fitzpatrick skin types III to V
•Participants with mild to moderate fine lines and wrinkles in periorbital area (Crow’s feet-under eye) & forehead (Refer annexure I for photo-numerical scale)
•Participants free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the f ace.
•Participants who agree not to use any other product/treatment/home remedy/soap bar on their face during the study period other than the test product.
•Participants who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
•Participants who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
•Participants who agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible, nose ring), during VISIA imaging.
•Participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow up.
•Participants willing to abide by and comply with the study protocol.
•Participants who have not participated in a similar investigation in past four weeks.
•Participants who are willing not to participate in any other clinical study during participation in the current study.
|
|
| ExclusionCriteria |
| Details |
•Participant with any other signs of significant local irritation or skin disease.
•Participant currently taking any medication, which the Investigator believes may influence the interpretation of the data.
•Participant having chronic illness or had major surgery in the last year.
•Participants undergoing any treatment of any skin condition on their face/forearm.
•Participants not willing to discontinue other topical facial products.
•Participant allergic or sensitive to bar cleansing products, creams/lotions, or anything else.
•Pregnant or nursing participant.
•Participants taking medication including food supplements.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Significant improvement of facial fine line; wrinkles as assessed by Antera
2.Significant improvement of skin elasticity as assessed by dermatological
assessment and Cutometer measurement.
3.Significant improvement in skin hydration as assessed by dermatological
assessment and Corneometer measurement
4. Significance improvement in overall changes in skin appearance in terms of
signs of aging by Dermatological assessment |
Screening, Baseline,Day35 &
Day70. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the product safety by dermatologist assessment |
Evaluation of safety through monitoring skin tolerance & AE (Baseline, Day35 & Day70). |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Not yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is to evaluate the anti-skin aging benefits in 10 weeks by dermatological assessment, self-assessment, non-invasive instrument assessment. Post enrolment to the study, baseline assessments will be performed which includes Dermatological visual assessment, instrument assessment (Cutometer, TEWL, Corneometer, Antera) and VISIA images will be captured Participants will be provided with either the test product or placebo cream as per the randomization and has to apply twice daily, morning and night before bed on face, throughout the study for 10 weeks. The participants will visit the study center at week 5 and week 10 for the follow up assessments (as in baseline) |