| CTRI Number |
CTRI/2024/06/068757 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate Skin Health Benefits of Skin-ceraâ„¢ in Healthy Human Volunteers |
|
Scientific Title of Study
|
A Double-Blind, Placebo-Controlled, Randomized, Parallel-group Study to Evaluate General Skin Health Benefits of Skin-ceraâ„¢ in Healthy Human Volunteers |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-VH-127 Version 1.0 dated 17 Mar 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjana A S |
| Designation |
Professor and HOD |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Department of Dermatology,No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
8792516793 |
| Fax |
|
| Email |
drsanjanaas.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road
Bangalore
KARNATAKA
560060
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road
KARNATAKA
560060
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidya Herbs Pvt Ltd.,
Vidya Building, N3-3
24th main road, 1st Phase, JP Nagar
Bengaluru, Karnataka - 560 078
India |
|
|
Primary Sponsor
|
| Name |
Vidya Herbs Pvt Ltd. |
| Address |
Vidya Building, N3-3
24th main road, 1st Phase, JP Nagar
Bengaluru, Karnataka - 560 078
India |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Sanjana A S |
BGS Global Institute of Medical Sciences |
Room No.01, Department of Dermatology, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
8792516793
drsanjanaas.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With normal Hematological and Biochemical Parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Maltodextrin |
Single dose, once a day for 8 weeks |
| Intervention |
Skin-ceraâ„¢ |
Single dose, once a day for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects presenting with dry skin and signs of photoaging.
2. Subjects not undergoing any supplementation for skin health.
3. Subject has not participated in a similar clinical investigation in the past three months.
4. Subject who is willing to abstain from using any fairness product, sunscreens, natural/ ayurvedic treatments or oral skin supplements or other home remedies and also willing to abstain from undergoing any facial treatments such as facial masks, packs, bleaching, etc either at home or at parlour during the entire study course.
5. In case of having used skin treatment in the near past, should be willing to undergo a wash out period of 1 week, wherein they should abstain from applying any product other than the provided cleanser on face.
6. Male subjects who are willing to maintain their facial skin condition as shaved at baseline and during the entire study course.
7. Female subjects of reproductive age group have negative urine pregnancy test (UPT) at screening visit.
8. Subject willing to give written informed consent and comply with the study procedures. |
|
| ExclusionCriteria |
| Details |
1. Subject with a medical history of disease or condition or a concurrent illness or pre-existing or dormant dermatologic condition that could interfere with the study results.
2.Subject who has used any systemic medication within past 4 weeks or any topical facial medication within 2 weeks prior to study commencement, which could compromise the study.
3.Subject with excessive facial hair or scars, which could interfere with evaluation.
4.Subject with a history of having used a similar product during or since 1 week prior to the scheduled study commencement.
5.Subject who is currently pregnant or nursing or contemplating pregnancy during the study course.
6.Subjects will history of drug or alcohol abuse or chronic smoking.
7.Subjects allergic to herbal products or any component of the study product
8.Known HIV or Hepatitis B positive or any other immuno-compromised state
9.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
10.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the efficacy parameters assessed in the investigational product arm compared to placebo from baseline to end of study |
Baseline, Week 4, Week 8, Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and Tolerability |
Baseline, Week 4, Week 8, Week 12 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
21/06/2024 |
| 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="6"
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 is a double blind, randomized, placebo controlled, two-arms, parallel group study. Healthy male and female subjects presenting dry skin, showing signs of skin aging, and meeting all inclusion and none of the exclusion criteria after signing a written informed consent will be enrolled in the study. After passing the eligibility criteria, the subjects will be randomized. Skin analysis will be performed in a subset population. Safety and Tolerability will be evaluated. |