Aging WellNCT05879289
Evaluation of the Effectiveness of the Anti-aging Effect of a Supplement in Improving Skin Conditions
A study testing A power supplement in people with Aging Well, run by Farmoquimica S.A. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging Well
- What is being tested?
- A power supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Jan 2022to 17 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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);
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Avaliação de eficácia do Efeito Antienvelhecimento de um Suplemento Alimentar na Melhora Das condições da Pele - Estudo Clínico, Subjetivo e Instrumental
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.
Read the 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
- Conditions
- Aging Well
- Being tested
- A power supplement
- Keywords
- dermal aging, elastic fiber, collagen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A power supplementDietary supplement
A dietary supplement containing vitamins and collagen
| Study group | Role | What they receive |
|---|---|---|
| Clinical Trial | Experimental | 36 participants using the product for 90 days. Aims to evaluate the clinical, subjective and instrumental usage Receives: Dietary Supplement: A power supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 90 days
Secondary outcomes (6)
Evaluation of skin firmness and elasticity using instrumental evaluation - Cutometer
Evaluate the efficacy of the investigational product in improving the firmness and elasticity of the skin through clinical and instrumental evaluations (cutometry) before using the product (D0) and after 45 (D45) and 90 (D90) days of continuous use;
Measured: Day 0, Day 45 e Day 90
Increase of skin hydration using instrumental evaluation - Corneometer
Evaluate the hydration efficacy before using the investigational product D(0) and after 45 (D45) and 90 (D90) days of continuous use through the Corneometer equipment®
Measured: Day 0, Day 45 e Day 90
Detection and accuracy of fine lines and wrinkles- Visia
Evaluate the efficacy of the investigational product in improving wrinkles through instrumental evaluations by Visia® before product use (D0) and after 45 (D45) and 90 (D90) days of use continuous
Measured: Day 0, Day 45 e Day 90
Increase in dermal thickness and density in the thigh region
Check the increase in dermal thickness and density in the thigh region through Ultrasound Volunson E8 before using the product (D0) and after 90 (D90) days of continuous
Measured: Day 0 e Day 90
Subjective efficacy from the participants
Evaluate the perceived efficacy of the product from the participant's point of view through a subjective questionnaire after 45 (D45) e 90 (D90) days of continuous use of the product
Measured: Day 45 e Day 90
Acceptability in real conditions of use through dermatological questionnaire
Check the absence of risk of irritation and capture sensations of discomfort from the studied population, through dermatological evaluation criteria.
Measured: Day 0, Day 45 e Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start25 Jan 2022
- Primary completion17 May 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging WellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farmoquimica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medcin Instituto da Pele Ltda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879289
- Sponsor's protocol ID
- EN20-1103
- Status last verified
- May 2023
- First submitted
- 17 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avaliação de eficácia do Efeito Antienvelhecimento de um Suplemento Alimentar na Melhora Das condições da Pele - Estudo Clínico, Subjetivo e Instrumental
- ClinicalTrials.gov ID
- NCT05879289
- Acronym / sponsor ID
- EN20-1103
- Conditions
- Aging Well
- Keywords
- dermal aging, elastic fiber, collagen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Farmoquimica S.A.Industry (pharma, biotech, devices)
- Collaborators
- Medcin Instituto da Pele Ltda
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Trial | Experimental | Dietary Supplement: A power supplement36 participants using the product for 90 days. Aims to evaluate the clinical, subjective and instrumental usage |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A power supplementA dietary supplement containing vitamins and collagen | Dietary supplement | Clinical Trial |
Primary outcome
Acceptability in real conditions of use by questionnaire
Time frame: 90 days
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)
6 secondary outcomes
Evaluation of skin firmness and elasticity using instrumental evaluation - Cutometer
Time frame: Day 0, Day 45 e Day 90
Increase of skin hydration using instrumental evaluation - Corneometer
Time frame: Day 0, Day 45 e Day 90
Detection and accuracy of fine lines and wrinkles- Visia
Time frame: Day 0, Day 45 e Day 90
Increase in dermal thickness and density in the thigh region
Time frame: Day 0 e Day 90
Subjective efficacy from the participants
Time frame: Day 45 e Day 90
Acceptability in real conditions of use through dermatological questionnaire
Time frame: Day 0, Day 45 e Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A power supplement in people with Aging Well, run by Farmoquimica S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability in real conditions of use by questionnaire (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.