| CTRI Number |
CTRI/2025/03/083576 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Improving skin health
in healthy female volunteers |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled, four arm clinical study to evaluate the
safety and efficacy of Fibre interlaced Liposomal (FIL) Vitamin C in improving skin health in healthy female volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/SH/FIL/2024 Version:1.0 Dated:15th Nov 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt. Ltd |
| Address |
Radiant Research Services Pvt. Ltd
Plot No:99/A, 8th Main Road, III Phase,
Peenya Industrial Area, Bengaluru-560058,
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt. Ltd |
| Address |
Radiant Research Services Pvt. Ltd
Plot No:99/A, 8th Main Road, III Phase,
Peenya Industrial Area, Bengaluru-560058,
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt. Ltd |
| Address |
Radiant Research Services Pvt. Ltd
Plot No:99/A, 8th Main Road, III Phase,
Peenya Industrial Area, Bengaluru-560058,
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@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 [ [Nutraceutical supplement company]] |
|
|
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 Madan Mohan N T |
Dr. B.R Ambedkar Medical College |
Department of Dermatology, #19, Venkateshpuram, Kadugondanahalli,
Bengaluru, Karnataka 560045
Bangalore
KARNATAKA |
8065733349
-
drmadan1969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. B.R Ambedkar Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral Capsules (Placebo) |
350 mg capsules is administered twice daily 30 minutes before food, Duration-84 days. |
| Intervention |
Fiber interlaced liposomal (FIL) vitamin C Capsules Oral (Active) |
FIL VITAMIN C 350 mg capsules is administered twice daily 30 minutes before food, Duration-84 days. |
| Intervention |
Fiber interlaced liposomal (FIL) vitamin C Cream Topical (Active) |
The topical formulation (Cream) A thin layer (a pea-sized amount) to be applied on the face twice daily morning and evening, Duration 84 days. |
| Comparator Agent |
Topical (Placebo) |
The topical formulation (Cream) A thin layer (a pea-sized amount) to be applied on the face twice daily morning and evening, Duration 84 days. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Ambulatory female subjects of 35-60 years with a Body Mass Index (BMI) of 18.5 to 24.9 kgm2. And having dry skin.
2. Subjects considered as healthy by Principal Investigator through medical history and laboratory results during screening.
3. Subjects who are having 3-6 degrees wrinkles in the crow’s-feet area, with global photo damage score between 3 and 6.
4. Subjects who are not taking Vitamin supplements.
5. Fitzpatrick Skin Photo types III to V
6. Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
7. Subjects voluntarily agree to participate, sign written informed consent and comply with study protocol.
8. Subjects willing not to undergo Skincare therapy, Laser therapy, BotoxFiller, ETC during the study period.
9. Subjects willing to not to take food that could effect on skin condition and continue their normal diet during the study period
10. Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrhoeic for at least 1 year or had a hysterectomy and or bilateral oophorectomy.
|
|
| ExclusionCriteria |
| Details |
1. Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
2. Individuals with sensitive or hypersensitive skin.
3. Psoriasis patients taking immunosuppressive drugs, severe atopic dermatitis patients.
4. Subjects with a history of photo allergy or photosensitization for minimal erythema test.
5. Expectation of any surgery during the study period.
6. Subject with history of allergies to cosmetics, pharmaceutical products, or foods
7. Use of topical retinoid, any other anti wrinkle steroid products and cosmetic products containing AHA, BHA within the 3 months prior to initiation of the study.
8. Subjects who are using moisture rich cosmetic products within the 2 weeks prior to study initiation.
9. Subjects with uncontrolled Diabetes and Hypertension
10. Subjects with history of renal or liver impairment, any endocrine, inflammatory, cardiovascular, gastro intestinal, neurological, psychiatric, neoplastic or metabolic disease.
11. Subjects suffering from COPD or having history of any respiratory or breathing disorders.
12. Subjects with HIV Positive status.
13. Alcohol intake greater than 2 standard drinks per day or use of recreational drugs such as cocaine, methamphetamine, marijuana, etc. and smokers.
14. Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
15. Clinically significant or abnormal laboratory results during screening.
16. Any condition judged by the investigator to be unsuitable for participation in the study.
17. Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study period.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes:
Change from baseline to the end of the study period in:
1. Skin elasticity by Cutometer.
2. Skin collagen measurement by Ultrasound.
3. Skin hydration by Corneometer.
4. Trans epidermal water loss (TEWL) by Tewameter.
5. Erythema index (EI) and melanin index (MI) by Mexameter. |
Visit2(day 0), Visit 3(Week 1), Visit 4(Week 6), Visit 5(week 12) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes:
Change from baseline to the end of the study period in:
1. Participants degree of satisfaction (Product Efficacy
Questionnaires, Product Characteristics Questionnaires and
Product Acceptability Questionnaires).
2. Skin stripping on dorsal region of hand – 10 layers for detection of SOD and catalase activity.(Visit2(day 0), Visit 3(Week 1), Visit 4(Week 6), Visit 5(week 12)) |
Visit 4(Week 6), Visit 5(week 12) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| Date of Study Completion (India) |
17/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Normal skin contains high concentrations of vitamin C, which supports important and well-known
functions, stimulating collagen synthesis and assisting in antioxidant protection against UV-
induced photodamage. This knowledge is often used as a rationale for the addition of vitamin C
to topical applications. Important and main mechanisms of action and clinical applications of
topical vitamin C on the skin also due to its antioxidative, photoprotective, antiaging, and ant
pigmentary effects.1 Topical vitamin C has a wide range of clinical applications, from antiaging
and ant pigmentary to photoprotective. Clinical studies on the efficacy of different formulations
of topical vitamin C in human skin remain limited. The challenge lies with developing a stable
formulation and finding the most efficient trans epidermal delivery method for the esterified forms
of vitamin C (e.g., ascorbyl palmitate) to maximize the concentration of active vitamin C in the
skin. Recent studies have shown that methods such as nanoparticles, multi-layered
microemulsions for graded delivery, ultrasound, iontophoresis, laser resurfacing, and
microdermabrasion, can help to enhance penetration of vitamin C. Unlike plants and some animals,
humans are unable to synthesize vitamin C due to absence of the enzyme L- glucono-gamma
lactone oxidase. Despite high doses of oral supplementation, only a small fraction of vitamin C will
be biologically available and active in the skin. |