| CTRI Number |
CTRI/2024/08/072010 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Nutraceutical |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
To Assess the Skin Tone Benefits of the Pearl Tomato® in Healthy Adults |
Scientific Title of Study
Modification(s)
|
A Single-Centre, Randomized Placebo-Controlled Study to Assess the Skin Tone Enhancement Benefits of the Pearl Tomato® in Healthy Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TG/CLI/086, Version 1.0, Dated 20 May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sohandas Shetty |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
#467, Room no 1, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
08867125414 |
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sohandas Shetty |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
#467, Room no 1, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
KARNATAKA
560083
India |
| Phone |
08867125414 |
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CRO representative |
| Affiliation |
TrialGuna Private Limited |
| Address |
#467, Room no 1, 3rd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
09972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Vesta Nutra, 5767 Thunderbird Road, Indianapolis, IN 46236 |
|
Primary Sponsor
Modification(s)
|
| Name |
Vesta Nutra |
| Address |
5767 Thunderbird Road, Indianapolis, IN 46236 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sohandas Shetty |
TrialGuna Private Limited |
#467, Room no 1, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA |
08867125414
drsohanshetty@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Adults |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Pearl Tomato®, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 400(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 400(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy Indian male and female participants aged 18-50 years.
2. Fitzpatrick Skin Types I-IV.
3. Presence of visible facial dark spots and pigmentation.
4. Healthy face skin free of eczema, wounds, and inflammatory scars.
5. Absence of signs of infectious and evolutive pathology.
6. Willing to comply with study requirements.
|
|
| ExclusionCriteria |
| Details |
1. Participants with chronic dermatosis or cutaneous hypersensitivity.
2. Clinically significant systemic or cutaneous disease, chronic illness, or recent major
surgery.
3. Allergy or sensitivity to specified products or substances.
4. Pregnant or breastfeeding women, or use of hormonal birth control.
5. Recent participation in another clinical trial.
6. Current medication influencing study interpretation.
7. Unwillingness to discontinue other facial products.
|
|
Method of Generating Random Sequence
Modification(s)
|
Stratified block randomization |
|
Method of Concealment
|
Other |
Blinding/Masking
Modification(s)
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1) Overall hyperpigmentation, skin tone, tactile smoothness, brightness, and radiance.
2) Improvement in skin brightness and investigator’s assessment on skin brightness, tone, smoothness, glow ,radiance, colour.
3) Measurement of skin tone , UV pigmentation, dark spots, pores and wrinkles.
4) Skin colour assessment using Colori Probe.
5) TEWL, Elasticity, and Hydration assessments using DermaLab Probes.
6) Change in tyrosinase biomarker level. |
Day 0, Day 15, Day 30, Day 60 & Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Record any change in vital signs (blood pressure, pulse rate, body temperature).
2. Record any change in CBS parameters, Liver Function Test (LFT), Renal Function Test (RFT) parameters and RBS.
3. Occurrence of the treatment-related adverse events (AEs) during study period.
4. Subjective assessment of treatment satisfaction, and
perception regarding changes in skin brightness, whiteness, and pigmentation. |
Day 0, Day 15, Day 30, Day 60 & Day 90 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
13/03/2025 |
| Date of Study Completion (India) |
11/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
The skin is the largest organ of the human body, and its appearance can be influenced by various internal and external factors. Skin tone enhancement, often referred to as skin brightening or lightening, has become a significant focus in dermatological research and the cosmetic industry. The pursuit of even skin tone and reduction of hyperpigmentation is driven by both aesthetic desires and clinical needs. Recently, there has been a growing interest in natural and safer alternatives for skin tone enhancement. Pre-clinical studies have elucidated the promising potential of Pearl Tomato extract in skincare formulations. Research conducted by Vesta Nutra has demonstrated the efficacy of Pearl Tomato as a melanin inhibitor and depigmentation agent. Pearl Tomato exhibited high melanin inhibition activity against UV- and Forskolin-induced melanin synthesis, as well as mushroom tyrosinase, an enzyme crucial for melanin production. |