Clinical Study on Fish Collagen of Athos Collagen Pvt. Ltd for improving Skin Health

Phase 3

Completed

Conditions: Volunteers looking to improve Skin Health

Registration Number: CTRI/2023/07/055042

Lead Sponsor: Athos Collagen Private Limited

Brief Summary: **Study Design :** Open label, Prospective , Non-Randomized, Non-Compartive Single ArmClinical Study

**Indication :**Skin Health

**Investigational Product :** FiColla

**Comparator:** NotApplicable. .Single Arm Non Comparative Study

**Dose/Dosage Dose :** 4grams in each sachet **Dosage :**One sachet to be emptied into 100 ml luke warm water, mixed welland consumed immediately.

**Subject Population :** Clinically healthy adult subjects between the ages of 30 and 55years (both ages and all genders inclusive) looking to improve their skinhealth.

**Number of Subjects :** 30 Evaluable Subjects

**Treatment Arms :** I

**Treatment Duration :** 90 days

**Efficacy Assessments Objective visual Assessment : m-Danielleâ€™s Criteria**: Day 01, Day 45, Day 90 **Clinical Grading of Skin :** Day 01, Day45, Day 90 **Subjective Assessment of Cosmetic Effects** : Day45, Day 90 **IP Feedback Questionnaire :** Day 90

**Safety Assessments Clinical Safety :** CBC, Serum Biochemistry **Monitoring adverse events**

**Background of the study:** The skin is an essential organ in the human body that serves as abarrier against external environmental factors like sunlight, temperature,dust, bacterial infection, and so on. Collagen is the buliding block protein ofour skin. As we become older , the amount of collagen in the body gets low.This makes the skin became less elastic and makes fine lines. Collagensupplements reduce the signs of aging such as wrinkles and fine lines byimproving the structure of skin.

**Purpose of the Study :** Collagen-based supplements have become a keystone in the managementof the ageing process, with proven ability to repair skin damage, bestowing ayouthful and healthy appearance sought in the pursuit of beauty. Collagen is anessential scaffold protein that gives smoothness and elasticity to skin, butits production declines with age. Agrowing number of scientific studies show exciting evidence that it is possibleto rejuvenate ageing or damaged skin, improve function of worn joints, andsupport personal wellbeing and vitality. In recent times, research on themechanisms which impact the production of collagen in skin and the idealorganization into functional fibres which give skin its characteristicelasticity and firmness has provided new insights into how this bio-scaffoldcan support cells, tissues and organs.

This clinical study is done to evaluate thesafety and Effectiveness of FiColla of Athos Collagen Private Limited as aNurtitional Supplement for skin health of adults.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

Clinically Healthy adult subjects between the age of 30 and 55 years ( both ages and all genders inclusive) looking to improve their skin health.
Subject with fine lines and wrinkles.
Subject who are willing to abstain from the use of herbal , allopathic or other nutritional Supplements (intervention) that are indicated at improving skin health.
Subjects who are rated as Grade 2-4 on the Wrinkle Severity Scale.
Subject who are willing to give informed consent for participation , able to comprehend and understand the responsibilities during screening and treatment period.
Subjects who are willing not to participate in any other clinical trail during participation in the current trail.

Exclusion Criteria

Subject with Known hypersensitivity to the ingredients of the investigational product 2.
Subjects who are on Collagen supplements in any form.
Subjects who are vegetarians/vegans who object to consumption of animal origin investigational product 4.
Subjects who are on tropical treatments /regimens (prescribed, clinical or self) of retinol, vitamin C, bakuchiol, peeling treatments of AHA, BHA, Glycolic Acid or any combination thereof aimed at improvement skin texture, hyperpigmentation, pore size.
Subjects who have an active dermatological procedure done up to 3 months prior to screening.
Subjects who have an active infection, disease or disorder that will prevent from fully satisfying the responsibilities of the study.
Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
Subjects on remission from cancer of any type less than 5 years at the time of screening.
Subjects who are planning a pregnancy and/or currently breastfeeding.
Subjects who have participated in a clinical study less than 1 month before screening.
Any significant medical condition (eg., significant psychiatric or neurological disorders, active alcohol,/drug abuse , etc), any medical condition that is unstable/poorly controlled or other factor ( e.g., planned relocation) that the investigator felt would interfere with study evaluations and study participation.
Subject who mentally unable to comphrened the responsibilities and adhere to the stipulations protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective visual Assessment : m-Danielleâ€™s Criteria : Reduction of greater than equal to 1 score from baseline.	Objective visual Assessment : m-Danielleâ€™s Criteria : Day 01, Day45, Day 90 \| Clinical Grading of Skin : Day 01, Day45, Day 90 \| Subjective Assessment of Cosmetic Effects : Day45, Day 90 \| IP Feedback Questionnarie : Day 90
Clinical Grading of Skin : Reduction of greater than equal to 20% percentage in total score from baseline.	Objective visual Assessment : m-Danielleâ€™s Criteria : Day 01, Day45, Day 90 \| Clinical Grading of Skin : Day 01, Day45, Day 90 \| Subjective Assessment of Cosmetic Effects : Day45, Day 90 \| IP Feedback Questionnarie : Day 90
Subjective Assessment of Cosmetic Effects : Total Score of lesser than equal to 15 by end of the study.	Objective visual Assessment : m-Danielleâ€™s Criteria : Day 01, Day45, Day 90 \| Clinical Grading of Skin : Day 01, Day45, Day 90 \| Subjective Assessment of Cosmetic Effects : Day45, Day 90 \| IP Feedback Questionnarie : Day 90
IP Feedback Questionnaire : Total Score of greater than or equal to 15 by end of the study	Objective visual Assessment : m-Danielleâ€™s Criteria : Day 01, Day45, Day 90 \| Clinical Grading of Skin : Day 01, Day45, Day 90 \| Subjective Assessment of Cosmetic Effects : Day45, Day 90 \| IP Feedback Questionnarie : Day 90

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1): Aurous HealthCare Research and Development India Pvt Ltd
🇮🇳
Chennai, TAMIL NADU, India
Aurous HealthCare Research and Development India Pvt Ltd
🇮🇳Chennai, TAMIL NADU, India
Dr VT Sriraam
Principal investigator
9840909155
md@auroushealthcare.com