Clinical trial NCT05879289: Evaluation of the Effectiveness of the Anti-aging Effect of a Supplement in Improving Skin Conditions
Official title: Avaliação de eficácia do Efeito Antienvelhecimento de um Suplemento Alimentar na Melhora Das condições da Pele - Estudo Clínico, Subjetivo e Instrumental
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Well
Keywords: dermal aging, elastic fiber, collagen
Lead sponsor: Farmoquimica S.A.
Sponsor class: INDUSTRY
Collaborators: name: Medcin Instituto da Pele Ltda
First posted: 2023-05-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

It will be necessary 33 female participants aged between 35 and 60 years old with signs of aging on the face and neck, complaining of body flaccidity and gynoid lipodystrophy.

The participant will remain in the study for 90 days using the product. Visits will be scheduled in D0, D45 and D90.

Instrumental evaluations: Evaluated on each visit:

* Skin elasticity and firmness using Cutometer - D0, D45 and D90;
* Skin hydration using Corneometer- D0,D45 and D90;
* Detection and accuracy of fine lines and wrinkles using Visia -D0,D45 and D90
* Dermal thickness and density in the thigh region using Ultrasound Voluson E8 before using the product (D0) and after 90 (D90) days of continuous use;
* Participants will respond to a subjective assessment using a questionnaire to capture possible feelings of discomfort during the study and subjective efficacy.
* A dermatologist will be available to monitor the participants throughout the study and respond an assessment of clinical efficiency

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acceptability in real conditions of use by questionnaire
timeFrame: 90 days
Secondary outcomes:
measure: Evaluation of skin firmness and elasticity using instrumental evaluation - Cutometer
timeFrame: Day 0, Day 45 e Day 90
measure: Increase of skin hydration using instrumental evaluation - Corneometer
timeFrame: Day 0, Day 45 e Day 90
measure: Detection and accuracy of fine lines and wrinkles- Visia
timeFrame: Day 0, Day 45 e Day 90
measure: Increase in dermal thickness and density in the thigh region
timeFrame: Day 0 e Day 90
measure: Subjective efficacy from the participants
timeFrame: Day 45 e Day 90
measure: Acceptability in real conditions of use through dermatological questionnaire
timeFrame: Day 0, Day 45 e Day 90
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Medcin Instituto da Pele
state: São Paulo
Study officials:
References: