Anti-agingNCT06059274
Anti-aging Repairing Serum: Efficacy and Tolerability Study
A study testing Topical serum in people with Anti-aging, run by Cosmetique Active International at 1 site in Brazil.
Trial summary
The study aimed to evaluate the effectiveness and tolerability of a dermocosmetic serum containing hyaluronic acid, vitamin B5, madecassoside and La Roche-Posay Thermal Spring Water in reducing skin aging signs. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anti-aging
- What is being tested?
- Topical serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Mar 2018to 7 Jun 2018
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- phototype I to IV
- presenting wrinkles on the forehead and/or peri-orbital area with grade ≥ 2 and ≤4 according to "Skin Aging Atlas"
- participant has not used any anti-aging products or performed aesthetic procedures over the last three months
Who cannot join
- pregnant, breastfeeding or immune compromised woman
- participant with cutaneous marks or active dermatoses on the tested area that could interfere with the evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of an Anti-aging Repairing Serum Containing Hyaluronic Acid, Vitamin B5, Madecassoside and La Roche-Posay Thermal Spring Water
The study aimed to evaluate the effectiveness and tolerability of a dermocosmetic serum containing hyaluronic acid, vitamin B5, madecassoside and La Roche-Posay Thermal Spring Water in reducing skin aging signs. The experimental clinical trial involved 34 participants aged 45 to 65 years who applied the serum twice a day for 84 days.
Read the detailed description
This experimental, mono-centric, open clinical trial was conducted in accordance with the principles of Resolution 466/2012 of the Conselho Nacional de Saúde do Brasil, ethical principles from the Declaration of Helsinki (and subsequent modifications) and Good Clinical Practice (GCP).
Quality control was applied to each stage of data handling to ensure that clinical data were generated, collected, processed, analyzed and reported according to the protocol, Standard Operating Procedures (SOP) and requirement of GCP.
Descriptive Statistics: Quantitative parameters, or those that can be reasonably treated as such, were summarized using measures of central tendency as mean and median and dispersion measures as standard deviation at each time of evaluation. Quantitative variables were summarized using frequencies and percentages. For each parameter (clinical evaluation scores and parameters derived from the Primos®) and each region (frontal, periocular, peri-oral and neck), graphical representations of means ± 95% Confidence Interval (CI) were elaborated for visual assessment of evolution over time.
- Conditions
- Anti-aging
- Being tested
- Topical serum
- Keywords
- anti-aging, skin barrier, dermocosmetic, wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical serumOther
Participants are asked to apply the topical serum twice daily for 84 days.
| Study group | Role | What they receive |
|---|---|---|
| Topical serum | Experimental | An investigational topical serum containing hyaluronic acid, vitamin B5, madecassoside and La Roche-Posay Thermal Spring Water Receives: Other: Topical serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrumental Assessment - Primos® Optical 3D
The Primos® Optical 3D (Canfield) device in vivo allows the measurement and evaluation of wrinkles through the technique of fringed projection, based on digital mirrors (DMDTM: Digital Mirco mirror Devices) directly on the skin surface of the participants.
Measured: from baseline to Day 84
Clinical assessment through Visual Analog Scale (VAS)
The dermatologist investigates the degree of roughness of the frontal, peri-orbital, peri-oral, neck and overall aspect according to the following parameters: number of wrinkles (no wrinkles / several wrinkles), wrinkles thickness (very thin wrinkle / very thick wrinkle), length of the wrinkle (very short wrinkle / very long wrinkle), depth of wrinkle (very superficial wrinkle / very deep wrinkle) on a line from 0 to 10.
Measured: from baseline to Day 84
Clinical assessment using the standard scale "Skin Aging Atlas"
The dermatologist investigates the frontal, peri-orbital, peri-oral and neck regions, comparing the roughness observed in the research regions with the images presented in the Skin Aging Atlas, establishing, for each area, a degree of roughness, that made possible the evaluation in the different experimental times.
Measured: from baseline to Day 84
Secondary outcomes (1)
Instrumental Assessment - VISIA-6®
Standardized photographs with VISIA-6® are taken of the participants' right, left and front profiles using standard and cross-polarized lights.
Measured: from baseline to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start14 Mar 2018
- Primary completion14 Mar 2018
- Study completion7 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joana Carvalho, Principal investigator, Centre International de Développement Pharmaceutique (CIDP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059274
- Sponsor's protocol ID
- 1718CBCL357-Serum
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of an Anti-aging Repairing Serum Containing Hyaluronic Acid, Vitamin B5, Madecassoside and La Roche-Posay Thermal Spring Water
- ClinicalTrials.gov ID
- NCT06059274
- Acronym / sponsor ID
- 1718CBCL357-Serum
- Conditions
- Anti-aging
- Keywords
- anti-aging, skin barrier, dermocosmetic, wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 28 Sep 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 aimed to evaluate the effectiveness and tolerability of a dermocosmetic serum containing hyaluronic acid, vitamin B5, madecassoside and La Roche-Posay Thermal Spring Water in reducing skin aging signs. The experimental clinical trial involved 34 participants aged 45 to 65 years who applied the serum twice a day for 84 days.
Detailed description
This experimental, mono-centric, open clinical trial was conducted in accordance with the principles of Resolution 466/2012 of the Conselho Nacional de Saúde do Brasil, ethical principles from the Declaration of Helsinki (and subsequent modifications) and Good Clinical Practice (GCP).
Quality control was applied to each stage of data handling to ensure that clinical data were generated, collected, processed, analyzed and reported according to the protocol, Standard Operating Procedures (SOP) and requirement of GCP.
Descriptive Statistics: Quantitative parameters, or those that can be reasonably treated as such, were summarized using measures of central tendency as mean and median and dispersion measures as standard deviation at each time of evaluation. Quantitative variables were summarized using frequencies and percentages. For each parameter (clinical evaluation scores and parameters derived from the Primos®) and each region (frontal, periocular, peri-oral and neck), graphical representations of means ± 95% Confidence Interval (CI) were elaborated for visual assessment of evolution over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical serum | Experimental | Other: Topical serumAn investigational topical serum containing hyaluronic acid, vitamin B5, madecassoside and La Roche-Posay Thermal Spring Water |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- phototype I to IV
- presenting wrinkles on the forehead and/or peri-orbital area with grade ≥ 2 and ≤4 according to "Skin Aging Atlas"
- participant has not used any anti-aging products or performed aesthetic procedures over the last three months
Key exclusion criteria (2 listed)
- pregnant, breastfeeding or immune compromised woman
- participant with cutaneous marks or active dermatoses on the tested area that could interfere with the evaluation
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 |
|---|---|---|
| Topical serumParticipants are asked to apply the topical serum twice daily for 84 days. | Other | Topical serum |
Primary outcome
Instrumental Assessment - Primos® Optical 3D
Time frame: from baseline to Day 84
The Primos® Optical 3D (Canfield) device in vivo allows the measurement and evaluation of wrinkles through the technique of fringed projection, based on digital mirrors (DMDTM: Digital Mirco mirror Devices) directly on the skin surface of the participants.
Clinical assessment through Visual Analog Scale (VAS)
Time frame: from baseline to Day 84
The dermatologist investigates the degree of roughness of the frontal, peri-orbital, peri-oral, neck and overall aspect according to the following parameters: number of wrinkles (no wrinkles / several wrinkles), wrinkles thickness (very thin wrinkle / very thick wrinkle), length of the wrinkle (very short wrinkle / very long wrinkle), depth of wrinkle (very superficial wrinkle / very deep wrinkle) on a line from 0 to 10.
Clinical assessment using the standard scale "Skin Aging Atlas"
Time frame: from baseline to Day 84
The dermatologist investigates the frontal, peri-orbital, peri-oral and neck regions, comparing the roughness observed in the research regions with the images presented in the Skin Aging Atlas, establishing, for each area, a degree of roughness, that made possible the evaluation in the different experimental times.
1 secondary outcome
Instrumental Assessment - VISIA-6®
Time frame: from baseline to Day 84
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 2 Oct 2023.
Related trials for Anti-aging
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion for Aging Frailty
Frailty
Recruiting
Clinical Study to Evaluate the Anti-aging Efficacy and Skin Radiance-enhancing Effect of Dermial®.
Healthy Adult Females
Active, not recruiting
Efficacy and Safety of a Topical Botanical Extract Formulation for Skin Aging
Aging, Dry Skin
Not yet recruiting
Efficacy Validation of Deep Microspicule Cream for Anti-aging and Whitening on Mature Skin
Efficacy Validation of Deep Microspicule Cream for Anti-aging and Whitening on Mature Skin
RecruitingEarly Phase 1
Secretome Treatment for Facial Rejuvenation
Facial Aging, Rejuvenation
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.
Joana Carvalho principal investigator
Centre International de Développement Pharmaceutique (CIDP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical serum in people with Anti-aging, run by Cosmetique Active International 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 3 inclusion and 2 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 2 Oct 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?
Instrumental Assessment - Primos® Optical 3D (time frame: from baseline to Day 84). The study lists 3 primary outcomes in all. 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 2 Oct 2023.