| CTRI Number |
CTRI/2025/05/087315 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [YTO-459 IN SUBJECTS WITH AGEING SIGNS] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Study to Check the Safety and Benefits of YTO-459 in People Showing Signs of Ageing (like wrinkles or tired-looking skin) |
|
Scientific Title of Study
|
An Open-Labelled, Multi-Arm, Single-Center Clinical Study to Evaluate the Safety and Efficacy of YTO-459 in Subjects with Ageing Signs. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2430 Version No. 1.0 Dated 14/Mar/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Kumar S |
| Designation |
Principal Investigator |
| Affiliation |
Currex Hospital |
| Address |
No.55-56, Seegehalli Main Road, Bhoo Samartha Layout,
Bangalore
KARNATAKA
560059
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
drudaykumar.derma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi L M |
| Designation |
HOD-Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit No.1204, Ashva, 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
09739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit No.1204, Ashva, 2nd Floor, 26th Main,Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Yuvan Research Inc, 319 N Bernardo Ave Mountain View, CA 94043 USA
|
|
|
Primary Sponsor
|
| Name |
Yuvan Research Inc |
| Address |
319 N Bernardo Ave Mountain View, CA 94043 USA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Uday Kumar S |
Currex Hospital |
Currex Hospital
No.55-56, Seegehalli Main Road, Bhoo Samartha Layout,
Seegehalli, KS Halli, Bengaluru
Bangalore
KARNATAKA |
06364898825
drudaykumar.derma@gmail.com |
|
|
Details of Ethics Committee
|
| 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 |
| Patients |
(1) ICD-10 Condition: L988||Other specified disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm-A : YTO-459 (without microdermabrasion) |
Application of YTO-459 on the back of the hand (without microdermabrasion). |
| Intervention |
Arm-B : YTO-459 with Microdermabrasion |
Application of YTO-459 on the back of the hand after microdermabrasion technique. |
| Comparator Agent |
Arm-C : YTO-459A |
Application of YTO-459A (second version with added excipients) on the back of the hand (without microdermabrasion). |
| Comparator Agent |
Arm-D : YTO-459A with Microdermabrasion |
Application of YTO-459A on the back of the hand after microdermabrasion technique. |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults of both sexes aged 55 years and above
2. Subjects with fine lines or wrinkles graded as Grade 1 or higher on the Allergan Fine Lines Scale
3. Subjects with mild to moderate crow’s feet wrinkles graded as 3 or above on the Modified Anti-Ageing Atlas 6-point scale
4. Subjects willing to participate in the study by providing signed informed consent |
|
| ExclusionCriteria |
| Details |
1. Refusal or inability to give informed consent to participate in the study
2. Subjects who have undergone any dermatological or surgical procedure of the hand
3. Subjects who are currently using or have used anti-aging anti-wrinkle Alpha hydroxy acids or retinol-based cosmetics in the past 3 months
4. Participation in or administration of any clinical trials or investigational drugs within 30 days prior to the screening visit
5. History of known bleeding disorders
6. Any relevant or clinically significant condition that may interfere with efficacy or safety assessments during the study drug administration
7. History of drug or alcohol abuse or addiction within the past 5 years
8. Persons under guardianship or those incapable of judgment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To measure the change in the skin after the study treatment using photometric analysis at the end of the study visit compared to the baseline visit between the treatment groups
2. To measure the change in class of wrinkle after the study treatment according to MFW Scale at the end of the study visit compared to the baseline visit between the treatment groups |
Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 9, Day 10, Day 11, Day 12, Day 15 and Day 23 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To measure the reduction of fine lines in the skin after the study treatment using Allergan Fine Lines Scale at the end of the study visit compared to the baseline visit between the treatment groups
2. To measure subject satisfaction after the study treatment using the subject satisfaction questionnaire at the end of the study visit compared to the baseline visit between the treatment groups
3. To measure improvement in the natural look and feel of the skin using Global Aesthetic Improvement Scale GAIS at the end of the study visit compared to the baseline visit between the treatment groups
4. To measure the proportion of participants with treatment emergent adverse events TEAEs leading to study treatment discontinuation between the treatment groups
5. To compare the rate of adverse events between the treatment groups |
Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 9, Day 10, Day 11, Day 12, Day 15 and Day 23 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 1 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="0"
Days="23" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Introduction and Background Ageing of the skin is a multifactorial biological process influenced by both intrinsic (natural ageing) and extrinsic (environmental) factors, especially prolonged exposure to ultraviolet radiation. This leads to structural and functional deterioration of skin components, including collagen and elastin. Collagen accounts for 70–80% of the skin’s dry weight and is responsible for mechanical strength, while elastin, though comprising only 2–4% of the dermal matrix, plays a vital role in skin elasticity. Photoaging, caused by UV exposure, results in the breakdown and disorganization of elastin fibers, leading to a condition known as solar elastosis—characterized by dense, dysfunctional elastotic material in the dermis. Recent advancements have highlighted the regenerative potential of adipose tissue, particularly through fat grafting and the use of mesenchymal stem cells (MSCs) found in the stromal vascular fraction (SVF). MSCs are multipotent cells capable of self-renewal and differentiation, and are now being explored for skin rejuvenation. Platelet-rich plasma (PRP) has also gained attention for its ability to promote tissue regeneration through growth factors and cytokines. PRP has been used in a wide range of dermatological and cosmetic treatments, including for wrinkles, scars, and wound healing. Building upon these regenerative approaches, a preclinical study demonstrated that plasma-derived exosomes—specifically E5, a proprietary horse blood plasma-derived exosome—may significantly improve cellular rejuvenation and metabolic function in animal models. Purpose of the Study The present clinical study aims to evaluate the safety and efficacy of YTO-459, a novel formulation containing horse plasma-derived exosomes, in individuals with visible signs of skin ageing such as fine lines and wrinkles. This study seeks to establish whether the regenerative properties observed in preclinical models translate into clinical benefits in human subjects, potentially offering a new non-invasive solution for age-related skin concerns. |