| CTRI Number |
CTRI/2011/11/002099 [Registered on: 01/11/2011] Trial Registered Prospectively |
| Last Modified On: |
26/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
TO ESTIMATE THE EFFECTIVENESS AND TOLERANCE OF A SKIN ANTI AGEING TEST PRODUCT IN WOMEN |
|
Scientific Title of Study
|
EVALUATION OF THE EFFICACY AND TOLERANCE OF A SKIN ANTI AGEING TEST PRODUCT IN WOMEN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/025/0911/POC |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Prinicipal Investigator |
| Affiliation |
Not Applicable |
| 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 |
66758851 |
| Fax |
66758854 |
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajiv Joshi |
| Designation |
Prinicipal Investigator |
| Affiliation |
|
| 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 |
66758851 |
| Fax |
66758854 |
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganeshchandra Sonavane |
| Designation |
Senior Fellow Scientist, Formulation, Research & Development |
| Affiliation |
Inventia Healthcare Pvt. Ltd |
| Address |
Inventia Healthcare Pvt. Ltd.
A-214, Road No. 30, Wagle Industrial Estate, Thane (West).
Mumbai
MAHARASHTRA
400604
India |
| Phone |
67163450 |
| Fax |
67163500 |
| Email |
ganesh.sonavane@inventiahealthcare.com |
|
|
Source of Monetary or Material Support
|
| Inventia Healthcare Pvt. Ltd.
A-131, Thevelek Compound, Road No.23, Wagle Estate, Thane(W)
Mumbai 400604.
|
|
|
Primary Sponsor
|
| Name |
Inventia Healthcare Pvt Ltd |
| Address |
A-214, Road No. 30, Wagle Industrial Estate, Thane (West) – 400 604 (India)
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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
Mumbai
MAHARASHTRA |
66758851
66758854
rsjdr@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with moderate wrinkles |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coenzyme Q10 Topical Gel (1 mg/gm). |
Gently apply 2 FTU of the product (1.0 g) to cleansed face & neck twice a day. Massage in an upward motion until fully absorbed.Product will be applied twice a day for 1 month. Product for external use. |
| Comparator Agent |
Placebo |
Gently apply 2 FTU of the product (1.0 g) to cleansed face & neck twice a day. Massage in an upward motion until fully absorbed.
Product will be applied twice a day for 1 month. Product for external use.
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Voluntary women with moderate wrinkles (not greater than 2- 3 fine lines extending upto lateral end of eyebrow, but not beyond).
2. Age Limit: 35 – 55 years.
3. Has been fully informed verbally and in writing and comply with the study specifications. Signature for participation in test.
4. Photo type: III (White skin which sometimes burns, difficult to tan) and IV (Moderate brown skin which rarely burns and tans with ease).
5. Accepting not to use products with same end benefit, or containing sunscreen, during the study.
6. Co-operating, informed of the need and duration of the examinations.
7. For which the Investigator considers that the compliance will be correct.
|
|
| ExclusionCriteria |
| Details |
1. Skin allergy antecedents or atopic subject.
2. Pregnant women (as confirmed by UPT) and lactating women.
3. Seasonal allergies/Hyper sensitivity to any cosmetic product.
4. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedure.
5. Subjects on any medical treatment either systemic/topical in the past 1 month which may interfere with the performance of the study treatment.
6. Subject in an exclusion period or participating in any other similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Primary Evaluation criteria (Primary Objective) for this study:
• Measuring depth of wrinkles around crow’s feet area using PRIMOS
• Hydration of Stratum corneum by MoistureMeter SC
• Cutometer measurements for elasticity and firmness.
The Secondary Evaluation Criteria (Primary Objective) for this study:
• Self evaluation questionnaire to evaluate the product efficacy and sensorial properties.
• Clinical Evaluation using skin age score.
|
The Primary Evaluation criteria (Primary Objective) :
• Measuring depth of wrinkles using PRIMOS on Day 0 and Day 30.
• Hydration by MoistureMeter SC on Day 0, 15 and 30.
• Cutometer measurements for elasticity and firmness on Day 0, 15 and 30.
The Secondary Evaluation Criteria (Primary Objective) :
• Self evaluation questionnaire to evaluate the product efficacy and sensorial properties on Day 15 and 30.
• Clinical Evaluation using skin age score on Day 0, 15 and 30.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Clinical Evaluation for tolerance |
Day 15 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2011 |
| Date of Study Completion (India) |
07/12/2011 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
· It is a test under dermatological control, monocentric, controlled, comparative versus initial state and Placebo. · On Day 0: Test site will be cleaned with water and volunteers will be acclimatized for 1 hour. · Clinical Evaluation using skin age score by Expert, MoistureMeter SC measurements and Cutometer measurements will be carried out on all volunteers at all visits on Day 0, Day 15 and Day 30. · PRIMOS evaluation of wrinkles in crow’s feet area will be carried out on Day 0 and Day 30. · Self-Evaluation questionnaire will be evaluated at Day 15 and Day 30 · Follow up visits will be on Day 15 and Day 30. · Digital photographs will be taken on Day 0, Day 15 and Day 30. |