Evaluation of the Effectiveness of the Anti-aging Effect of a Supplement in Improving Skin Conditions

NCT05879289 | Completed

• 1 other identifier: EN20-1103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A unicentric, blind, non-comparative clinical study to evaluate facial and body anti-aging efficacy of a supplement in female participants through clinical, subjective and instrumental evaluations.

Conditions

Aging Well

Keywords

dermal aging, elastic fiber, collagen

Outcome Measures

Primary Outcomes (1)

• Acceptability in real conditions of use by questionnaire

  Evaluate the effectiveness of the investigational product (nutritional supplement) in improving signs of facial and body aging, through clinical, instrumental and subjective evaluations. Confirm in real conditions of use, the absence of risk and irritation and capture feelings of discomfort in the population studied (0 meaning no risk)

  90 days

Secondary Outcomes (6)

• Evaluation of skin firmness and elasticity using instrumental evaluation - Cutometer

  Day 0, Day 45 e Day 90

• Increase of skin hydration using instrumental evaluation - Corneometer

  Day 0, Day 45 e Day 90

• Detection and accuracy of fine lines and wrinkles- Visia

  Day 0, Day 45 e Day 90

• Increase in dermal thickness and density in the thigh region

  Day 0 e Day 90

• Subjective efficacy from the participants

  Day 45 e Day 90

Study Arms (1)

Clinical Trial

EXPERIMENTAL

36 participants using the product for 90 days. Aims to evaluate the clinical, subjective and instrumental usage

Dietary Supplement: A power supplement

Interventions

A power supplement DIETARY_SUPPLEMENT

A dietary supplement containing vitamins and collagen

Clinical Trial

Eligibility Criteria

• Age: 35 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signs of aging in the face and neck region (fine lines, furrows and expression lines);
• Participants with complaints of body sagging;
• Participants with BMI \< 30 (body mass index less than 30);
• Participants with Gynoid Lipodystrophy Grade 1 and/or 2;
• Agreement to follow the trial procedures and attend the clinic on the days and times determined.
• Ability to understand and consent to their participation in this clinical study, manifested by signing the Term of Free and Informed Consent (TCLE)

You may not qualify if:

• Participants who have been diagnosed with COVID-19 by RT-PCR examination or by the presence of IgM antibodies in the serology exam, in the last 4 weeks or who are presenting any of the following symptoms: dry or productive cough, sneezing, runny nose, body ache, headache, anosmia (loss of smell), ageusia (loss of taste) and/or any other symptoms that may be related to covid-19 at the discretion of the investigator;
• Pregnancy or risk of pregnancy/lactation;
• Use of the following topical or systemic medications: immunosuppressants, antihistamines, anti-inflammatories non-hormonal drugs, and corticoids up to 30 days before selection or considering immunosuppressants, the interval should be 3 months before selection;
• Atopic or allergic history to Food Supplements;
• Pathologies and/or active skin lesions (local and/or disseminated) in the assessment area;
• Skin marks in the experimental area that interfere with the evaluation of possible skin reactions (malformations vascular lesions, scars, increased hairiness, large nevus, sunburn);
• Immunosuppression by drugs or active diseases;
• Decompensated endocrinopathies;
• Participants with known congenital or acquired immunodeficiency;
• Relevant medical history or current evidence of alcohol or other drug abuse;
• Known history or suspected intolerance to products of the same category;
• Intense sun exposure up to 15 days before the evaluation;
• Aesthetic or dermatological treatment in the evaluation areas up to 04 weeks before selection;
• Professionals directly involved in carrying out this study;
• Other conditions considered by the evaluating physician as reasonable for disqualification from participation in the study. If so, it should be described under observation in the clinical record

Sponsors & Collaborators

• Farmoquimica S.A.: lead
• Medcin Instituto da Pele Ltda: collaborator

Study Sites (1)

Medcin Instituto da Pele

Osasco, São Paulo, 06023-000, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 30, 2023
• Study Start: January 25, 2022
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 90 Days

Locations

BR (1)