| CTRI Number |
CTRI/2025/05/087675 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Improving Skin Health in Healthy Male or Female Volunteers. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled, Three Arm Clinical Study to Evaluate the Safety and Efficacy of Lutein Extract in Improving Skin Health in Healthy Male or Female Volunteers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/IB/SkinHealth/Lutein/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.
NO.99/A, 8th Main Road, 3rd Phase, Peenya Industrial Area, Bengaluru-560 068 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.
NO.99/A, 8th Main Road, 3rd Phase, Peenya Industrial Area, Bengaluru-560 068 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.
NO.99/A, 8th Main Road, 3rd Phase, Peenya Industrial Area, Bengaluru-560 068 Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ingex Botanicals Private Limited
No.508, Medini, 60 ft road F Block,
Sahakaranagar, Bengaluru-560092,
Karnataka, India
|
|
|
Primary Sponsor
|
| Name |
Ingex Botanicals Private Limited |
| Address |
No.508, Medini, 60 ft road F Block,
Sahakaranagar, Bengaluru-560092,
Karnataka, 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 |
| DrMonika M Gowda |
Medastar Speciality Hospital |
Department of dermatologist 641/17/1/3, Kodigehalli Main Road, Sahakar Nagar, Bangalore- 560092, Karnataka, India.
Bangalore
KARNATAKA |
9884457106
drmonikagowda.medstar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medstar Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Lutein 10 mg
Zeaxanthin 2 mg |
8 grams of granules should be reconstituted in 200 mL of water to prepare a beverage and consumed with breakfast,Duration:84 days |
| Intervention |
Lutein 20 mg
Zeaxanthin 4 mg |
8 grams of granules should be reconstituted in 200 mL of water to prepare a beverage and consumed with breakfast,Duration:84 days |
| Comparator Agent |
Starch 20 mg |
8 grams of granules should be reconstituted in 200 mL of water to prepare a beverage and consumed with breakfast,Duration:84 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Ambulatory, male and female subjects of 40-60 years’ age with a Body
Mass Index (BMI) of 20 to 29 kg/m2.
2. Subjects considered as healthy by Principal Investigator through medical
history and laboratory results during screening.
3. Subjects who are having 3-5 degrees wrinkles in the crow’s-feet area,
with global photodamage score between 3 and 6, and water content 170
or less on both left and right cheeks.
4. Fitzpatrick Skin Phototypes III to V
5. Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds,
lacerations, or any other active skin conditions on the face.
6. Subjects voluntarily agree to participate, sign written informed consent
and comply with study protocol.
7. Subjects willing not to undergo Skincare therapy, Laser therapy,
Botox/Filler, ETC during the study period.
8. Subjects willing to not to take food that could effect on skin condition
and continue their normal diet during the study period
9. 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. Expectation of any surgery during the study period.
2. Subject with history of allergies to cosmetics pharmaceutical products or foods containing ingredients included in the study supplement.
3. Use of topical retinoids, any other anti-wrinkle steroid products and cosmetic products containing AHA BHA within the 3 months prior to initiation of the study.
4. Subjects who are using moisture-rich cosmetic products within the 2 Weeks prior to study initiation.
5. Subjects with uncontrolled Diabetes FPG greater than 126 mgdL and Hypertension Systolic greater than 140 mmHg and Diastolic greater than 90 mmHg.
6. Subjects with history of renal or liver impairment, any endocrine, inflammatory cardiovascular gastro-intestinal neurological psychiatric neoplastic or metabolic disease.
7. Subjects suffering from COPD or having history of any respiratory or breathing disorders.
8. Subjects with HIV Positive status.
9. Alcohol intake more than 2 standard drinks per day or use of recreational drugs such as cocaine methamphetamine marijuana etc. and smokers.
10. Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
11. Clinically significant or abnormal laboratory results during screening.
12. Any condition judged by the investigator to be unsuitable for participation in the study.
13. 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 |
1.Change in Skin hydration from baseline to visit 3 (Week 6) and visit 4
(Week 12).
2.Change in Elasticity from baseline to visit 3 (Week 6) and visit 4 (Week
12).
3.Change in Trans epidermal water loss (TEWL) from baseline to visit 3
(Week 6) and visit 4 (Week 12).
4.Change Erythema index (EI) and melanin index (MI) from baseline to visit 3 (Week 6) and visit 4 (Week 12).
5.Change in Skin collagen measurement from baseline to visit 3 (Week 6)
and visit 4(Week 12).
6.Change in Serum Antioxidant levels (SOD & CAT) from baseline to
visit 3 (Week 6) and visit 4(Week 12).
7.Change in Serum Lutein and Zeaxanthin levels from baseline to visit
4 (week 12).
8.Change in Skin Keratinocytes from baseline to visit 4 (week 12). |
Day 0, Day 42, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in Ceramide, Fibrillin and GSH from baseline to visit 3 (Week
6) and visit 4 (Week 12).
2.Change in Participants degree of satisfaction (Questionnaire) from
baseline to visit 3 (Week 6) and visit 4(Week 12).
3.Change in DLQI Questionnaire from baseline to visit 3 (Week 6) and visit 4(Week 12). |
Day 0, Day 42, Day 84. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
09/06/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Skin health is not only significantly affected by aging, but also by other lifestyle-related factors, such as sun exposure, exercise and eating habits, smoking or alcohol intake. It is known that the cutaneous tissue can exhibit visible signs of senescence, such as dull complexion, loss of firmness, or changes in pigmentation.
Exposure to solar radiation is one of the m ain factors that contribute to skin aging, since ultraviolet (UV) radiation stimulates the formation of free radicals, which can cause oxidative stress. Oxidative stress in the skin is related to mutations and photoaging. Photoaging is an accumulative process and dependents on the rate and frequency of sun exposure, as well as skin phototype (skin pigmentation). UVA radiation can penetrate through the epidermis to the dermis, causing damage to the connective tissue, or extracellular matrix (ECM), represented here by collagen, elastin and glycosaminoglycan (GAGs). Damage to these structures generates visible damage in the skin, such as loss of elasticity, hydration and skin firmness, resulting in the appearance of wrinkles and increased fragility |