| CTRI Number |
CTRI/2024/04/066264 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [anti-ageing study] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check anti-ageing benefit of products |
|
Scientific Title of Study
|
To Clinical Study Evaluate the Efficacy of the Test Products in Providing Anti- Ageing Benefits |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/AVAG/2024-02 ver 1.0 dated 2 Apr 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research |
| Address |
Department of Skin Sciences,
#324, Second Floor,
1st Main Road, Cambridge Layout,
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukesh.ramnane@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research |
| Address |
Department of Skin Sciences,
#324, Second Floor,
1st Main Road, Cambridge Layout,
Ulsoor
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukesh.ramnane@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research |
| Address |
Department of Skin Sciences,
#324, Second Floor,
1st Main Road, Cambridge Layout,
Ulsoor
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukesh.ramnane@msclinical.com |
|
|
Source of Monetary or Material Support
|
| AVT Natural Products Limited
Plot.No225/1A 5-7, S Vazhakulam,
Marampilly P.O
Aluva-Cochin
Kerala-683105
India |
|
|
Primary Sponsor
|
| Name |
AVT Natural Products Limited |
| Address |
Plot.No 225/1A 5-7,
S Vazhakulam, Marampilly
P.O Aluva-Cochin 683105
Kerala India |
| Type of Sponsor |
Other [FMCG (Fast moving Consumer Goods)] |
|
|
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 Pvt. Ltd |
Department of Skin Sciences,
#324, Second Floor,
1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA |
08041125934
mukesh.ramnane@msclinical.com |
|
|
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 |
Healthy female volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AAG-1 |
After washing the face, apply 4-5 drops of the serum twicw daily onto threir entire face distributing it in small dots using the dropper. Gently spread the serum all over your face, ensuring even coverage. |
| Comparator Agent |
AAG-2 |
After washing the face, apply 4-5 drops of the serum twicw daily onto threir entire face distributing it in small dots using the dropper. Gently spread the serum all over your face, ensuring even coverage. |
| Intervention |
PSP- A |
After washing the face, apply 4-5 drops of the serum twicw daily onto threir entire face distributing it in small dots using the dropper. Gently spread the serum all over your face, ensuring even coverage.
|
| Comparator Agent |
PSP-B |
After washing the face, apply 4-5 drops of the serum twicw daily onto threir entire face distributing it in small dots using the dropper. Gently spread the serum all over your face, ensuring even coverage. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Female adult subjects in general good health as determined from general physical examination, dermatological assessment.
2. Subjects in the age group of 30 to 50 years (both ages inclusive).
3. Subjects having dull or uneven skin or any other pigmentation.
4. Subject presenting at least 2 well defined dark spots of PIH or Acne or Age spots on the face.
5. Subject identified for fine lines of score 4 and above and wrinkles of score 2 and above
6. Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face as determined by the dermatologist.
7. Subject who agrees not to use any other product or treatment or home remedy or except the provided product on their face during the study period other than the test product.
8. Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
9. Subjects who agree not to expose to excessive direct sun light (sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
10. Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow up.
11. Subjects willing to abide by and comply with the study protocol. |
|
| ExclusionCriteria |
| Details |
1. Subject with any other signs of significant local irritation or skin disease.
2. Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
3. Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
4. Subjects undergoing any treatment of any skin condition on their face.
5. Subjects not willing to discontinue other topical facial products.
6. Subject allergic or sensitive to bar, cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.
7. Subjects who are pregnant and lactating (Self- declared).
8. Subject who has participated in a similar clinical investigation in the past two weeks.
9. Subjects with skin allergy, history of atopic dermatitis or psoriasis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Improvement in hydration in comparison to Baseline and at different timepoints.
• Improvement in skin barrier function in comparison to Baseline and at different timepoints.
• Improvement in skin firmness/elasticity in comparison to Baseline and at different timepoints.
• Improvement in Wrinkles, Fine lines and Dark Spots in comparison to Baseline and at different timepoints. |
Day -7 (washout), Day 0, Day 28, Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate dermatological safety and tolerability of the test product for the entire study duration. |
Day -7 (washout), Day 0, Day 28, Day 56 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/05/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 monocentric, double-blinded, full-face, randomized study evaluates the efficacy and safety of an anti-aging product over a 9-week period with 4 visits. Initially, 120 subjects who meet the inclusion and exclusion criteria will provide informed consent and undergo randomization into four groups. A 7-day washout period follows enrollment during which subjects must avoid all anti-aging products. Visit 1 (Screening): Post-enrollment, subjects return after 7 days for their baseline assessments. Visit 2 (Baseline): Subjects acclimatize for 10 minutes in controlled conditions before undergoing sequential assessments including dermatological evaluations and various instrument measurements, followed by a self-assessment. Post-assessment, subjects receive the study product for twice-daily application. Visits 3 and 4 (Weeks 4 and 8): Compliance is verified, and after acclimatization, the same sequence of assessments is repeated. Subjects are instructed to bring their test products and diaries to these visits for verification. |