| CTRI Number |
CTRI/2018/02/012079 [Registered on: 22/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
28/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin Cosmetic Formulation] |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect and any untoward effects of Anti-aging Cream in healthy Indian women, for a duration of 12 weeks |
|
Scientific Title of Study
|
Assessment of the efficacy and tolerance of a topical anti-aging Cream in healthy Indian women, for 12 weeks |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/074/0118/STU |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. PVT.LTD |
| Address |
C.L.A.I.M.S. PVT.LTD
4th floor, B wing, Modi House,
C-10, Dalia Industrial Estate,
New Link Road, Andheri(W), Mumbai
Mumbai
MAHARASHTRA
400058
India |
| Phone |
2266758851 |
| Fax |
2266758851 |
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. PVT.LTD |
| Address |
C.L.A.I.M.S. PVT.LTD
4th floor, B wing, Modi House,
C-10, Dalia Industrial Estate,
New Link Road, Andheri(W), Mumbai
Mumbai
MAHARASHTRA
400058
India |
| Phone |
2266758851 |
| Fax |
2266758851 |
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Jaish Jacob |
| Designation |
Project Management |
| Affiliation |
Dabur Research Foundation |
| Address |
Dabur Research Foundation
22, Site IV, Sahibabad
Ghaziabad - 201010
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
08130970158 |
| Fax |
|
| Email |
jaish.jacob@daburresearch.in |
|
|
Source of Monetary or Material Support
|
| Dabur Research Foundation
22, Site IV, Sahibabad
Ghaziabad - 201010. India |
|
|
Primary Sponsor
|
| Name |
Dabur Research Foundation |
| Address |
Dabur Research Foundation
22, Site IV, Sahibabad
Ghaziabad - 201010. India |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Rajiv Joshi |
C.L.A.I.M.S. PVT.LTD |
4th floor, B wing,
Modi House, C-10, Dalia Industrial Estate,
New Link Road, Andheri(W), Mumbai-400058,
Tel:91-22-66758851
Mumbai
MAHARASHTRA |
2266758851
2266758854
rsjd@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with mild to moderate wrinkles |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
SIRB-001 Skin Cream |
Approximately 1.0 g to be applied on entire face and front neck areas and massaged gently for 30 seconds. To be used twice daily for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Participants with mild to moderate wrinkles.
Healthy skin on face
Willingness to avoid intense UV exposure as far as possible for the entire study duration |
|
| ExclusionCriteria |
| Details |
Pregnant women by UPT /lactating women.
Any skin disease on face
Subjects on any anti- ageing products, any health or nutritional supplements or any supplements which improves the skin condition or on anti-oxidants.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical assessment (Wrinkles in crow’s feet area, nasolabial, forehead, undereye, Pores
and Brown spots)
Instrumental Assessment
Subjective Self-assessment
Digital Photographs |
Day 0, Week 6, Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical evaluation for in use skin tolerance
Evaluation questionnaire for in use skin tolerance |
Day 0, Week 6, Week 12 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/02/2018 |
| Date of Study Completion (India) |
08/05/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
At the end of study,
Based on clinical evaluation it can be concluded that SIRB-001 AA Cream- Batch No.: AAC/001/18 was efficacious in - Significantly reducing the wrinkles/finelines on forehead - Significantly reducing the undereye wrinkles/finelines - Significantly reducing the severity of pores.
Based on instrumental evaluation it can be concluded that SIRB-001 AA Cream- Batch No.: AAC/001/18 was efficacious in - Significantly reducing the width of wrinkles/finelines around crow’s feet area
Based on subjective self-evaluation - 100% of participants agreed that their skin had become well hydrated, firm/ tight, even toned, smooth and soft, there was visible glow on face, there was a visible improvement in age spots and pigmentation present on face and in facial skin texture. - More than 90% of participants agreed that there was a reduction in wrinkles around the region of eye and wrinkles and fine lines on face.
Based on clinical and subjective self-evaluation SIRB-001 AA Cream was very well tolerated by all participants. |