A Study to Check the Safety and Benefits of YTO-459 in People Showing Signs of Ageing (like wrinkles or tired-looking skin)

Phase 1

Recruiting

Conditions: Other specified disorders of the skin and subcutaneous tissue,

Registration Number: CTRI/2025/05/087315

Lead Sponsor: Yuvan Research Inc

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 20

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Currex Hospital
🇮🇳
Bangalore, KARNATAKA, India
Currex Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Uday Kumar S
Principal investigator
06364898825
drudaykumar.derma@gmail.com