Skin AgingNCT05997654
Evaluation of the Safety and Effectiveness of the Investigational Product in Improvement of the Appearance of Wrinkles and General Aspect of the Skin
A study testing MEDGEL ANTIAGE in people with Skin Aging, run by Silimed Industria de Implantes Ltda at 1 site in Brazil.
Trial summary
The study investigates the safety and effectiveness of SILIMED® brand MEDGEL ANTIAGE with indication for improvement of the appearance of wrinkles and general aspects of the skin. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- MEDGEL ANTIAGE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 17 May 2023to 6 Jul 2023
- 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 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants aged between 30 and 55 years old;
- Participants with all skin types (normal, dry, combination and oily);
- Participants with mild to moderate signs of aging, according to Lanier's classification;
- Participants with melanic and/or vascular dark circles;
- Participants with bags around their eyes;
- Users of products from the same category;
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- Intact skin in the product analysis region (face);
- Participants who agree NOT to use any other topical products on the test area during the study period;
- Agreement to comply with the trial procedures and to attend the clinic on the specified days and times;
- Understand, consent and sign the informed consent.
Who cannot join
- Participants diagnosed with COVID-19 in the last 4 weeks or showing symptoms such as fever, dry cough, tiredness, body aches or other discomfort;
- Pregnancy/lactation or intention to become pregnant during the study period;
- Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticoids up to 30 days before selection or considering immunosuppressants, the interval should be 3 months before selection;
- Atopic or allergic history of health products;
- 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 (vascular malformations, scars, increased hairiness, large amounts of 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 in the same category
- Intense sun exposure up to 15 days before the assessment;
- Aesthetic or dermatological treatment in the evaluation area 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 participating in the study. If yes, it should be described in observation in the clinical record
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Effectiveness of the Investigational Product in Improvement of the Appearance of Wrinkles and General Aspect of the Skin - Clinical, Instrumental and Subjective Study
The study investigates the safety and effectiveness of SILIMED® brand MEDGEL ANTIAGE with indication for improvement of the appearance of wrinkles and general aspects of the skin.
- Conditions
- Skin Aging
- Being tested
- MEDGEL ANTIAGE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDGEL ANTIAGEDevice
The MEDGEL ANTIAGE is a medical grade silicone plate, biocompatible.
| Study group | Role | What they receive |
|---|---|---|
| Instrumental procedures and safety and efficacy assessments | Experimental | Group I: 23 participants who will undergo instrumental procedures, perceived efficacy questionnaires and clinical assessments of safety and efficacy.
Group II: 10 participants who will only perform perceived efficacy questionnaires and clinical assessments of safety and efficacy. Receives: Device: MEDGEL ANTIAGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Absence of risk of irritation and capture sensations of discomfort in the studied population through dermatological clinical evaluations before and after continuous use of the experimental product.
Measured: 28 days
Secondary outcomes (5)
Change in skin hydration
Evaluate the effectiveness in changing skin hydration, through measurements by the CORNEOMETER® equipment after 1h, 2h, 4h, 6h and 8h of product contact with the skin and after 28 days of continuous use.
Measured: 1h, 2h, 4h, 6h, 8h and after 28 days
% of change in melanic and vascular dark circles
Evaluate the effectiveness of the investigational product in changing % of melanic and vascular dark circles through photographic recording by the VISIA® equipment and image analysis by Image Pro Plus, before use (D0) and after continuous use (D28).
Measured: Before use and after 28 days of continuous use
Change in skin firmness and elasticity
Evaluate the effectiveness of the investigational product in changing skin firmness and elasticity through instrumental measurements by the CUTOMETER® equipment, before use (D0) and after continuous use (D28).
Measured: Before use and after 28 days of continuous use
Change in furrows and wrinkles depth
Evaluate the effectiveness of the investigational product in changing furrows and wrinkles depth through photographic records by the PRIMOS® equipment, before use (D0) and after continuous use (D28).
Measured: Before use and after 28 days of continuous use
Satisfaction assessed by a subjective questionnaire using a standardized 05-point scale
Evaluate the satisfaction with the investigational product from the point of view of the target population through a subjective questionnaire using a standardized 05-point scale answered before (D0) and after continuous use (D28).
Measured: Before use and after 28 days of continuous use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start17 May 2023
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silimed Industria de Implantes Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medcin Instituto da Pele Ltda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997654
- Sponsor's protocol ID
- EN22-0300-01
- Status last verified
- Aug 2023
- First submitted
- 21 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of the Investigational Product in Improvement of the Appearance of Wrinkles and General Aspect of the Skin - Clinical, Instrumental and Subjective Study
- ClinicalTrials.gov ID
- NCT05997654
- Acronym / sponsor ID
- EN22-0300-01
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Silimed Industria de Implantes LtdaIndustry (pharma, biotech, devices)
- Collaborators
- Medcin Instituto da Pele Ltda
- Study start
- 17 May 2023 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 18 Aug 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.
The study investigates the safety and effectiveness of SILIMED® brand MEDGEL ANTIAGE with indication for improvement of the appearance of wrinkles and general aspects of the skin.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Instrumental procedures and safety and efficacy assessments | Experimental | Device: MEDGEL ANTIAGEGroup I: 23 participants who will undergo instrumental procedures, perceived efficacy questionnaires and clinical assessments of safety and efficacy. Group II: 10 participants who will only perform perceived efficacy questionnaires and clinical assessments of safety and efficacy. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Participants aged between 30 and 55 years old;
- Participants with all skin types (normal, dry, combination and oily);
- Participants with mild to moderate signs of aging, according to Lanier's classification;
- Participants with melanic and/or vascular dark circles;
- Participants with bags around their eyes;
Key exclusion criteria (15 listed)
- Participants diagnosed with COVID-19 in the last 4 weeks or showing symptoms such as fever, dry cough, tiredness, body aches or other discomfort;
- Pregnancy/lactation or intention to become pregnant during the study period;
- Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticoids up to 30 days before selection or considering immunosuppressants, the interval should be 3 months before selection;
- Atopic or allergic history of health products;
- 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 |
|---|---|---|
| MEDGEL ANTIAGEThe MEDGEL ANTIAGE is a medical grade silicone plate, biocompatible. | Device | Instrumental procedures and safety and efficacy assessments |
Primary outcome
Frequency of adverse events
Time frame: 28 days
Absence of risk of irritation and capture sensations of discomfort in the studied population through dermatological clinical evaluations before and after continuous use of the experimental product.
5 secondary outcomes
Change in skin hydration
Time frame: 1h, 2h, 4h, 6h, 8h and after 28 days
% of change in melanic and vascular dark circles
Time frame: Before use and after 28 days of continuous use
Change in skin firmness and elasticity
Time frame: Before use and after 28 days of continuous use
Change in furrows and wrinkles depth
Time frame: Before use and after 28 days of continuous use
Satisfaction assessed by a subjective questionnaire using a standardized 05-point scale
Time frame: Before use and after 28 days of continuous use
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 18 Aug 2023.
- Individual participant dataSharing planned: No
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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 MEDGEL ANTIAGE in people with Skin Aging, run by Silimed Industria de Implantes Ltda 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 10 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 18 Aug 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?
Frequency of adverse events (time frame: 28 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 18 Aug 2023.