AgingNCT06697288
Evaluation of Efficacy of Anthelios Sunscreen on Face Versus Usual Routine on Signs of Aging
A study testing Tested product group in people with Aging, run by Cosmetique Active International at 1 site in Brazil.
Trial summary
This experimental, randomized study aims at evaluating the preventative effect of a Sun Protection Factor (SPF) 50+ sunscreen (Anthelios UVMUNE 400 Fluid SPF 50+) with high Ultraviolet A (UVA) protection on clinical signs of skin aging. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Tested product group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Apr 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with signs of photo aging (Global score of at least 14)
- All skin types
Who cannot join
- Any history of significant dermatological/ophthalmological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site
- Pregnant or breastfeeding women
- Subject with known allergy to cosmetic products or to any ingredient of the sunscreen product
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
CIDP
Rio de Janeiro, 20231-048
Renato Moura
About this study
Official title: Evaluation of the Efficacy of the UVMune 400 Fluid Sunscreen on the Face Versus Usual Photoprotection Routine on Visible and Measurable Signs of Aging
This experimental, randomized study aims at evaluating the preventative effect of a Sun Protection Factor (SPF) 50+ sunscreen (Anthelios UVMUNE 400 Fluid SPF 50+) with high Ultraviolet A (UVA) protection on clinical signs of skin aging.
Read the detailed description
The study will be conducted in compliance with the protocol, current internal procedures and in the spirit of the International Council on Harmonisation (ICH) Topic E6(R2)5 ref: EMA/CHMP/ICH/135/1995, ICH Good Clinical Practice (GCP) Addendum Nov 2016 and applicable regulatory requirement.
Statistical plan: Tx represents the values observed at Time x, for each parameter and by subgroup. Quantitative variables, or those that can reasonably be treated as such, will be summarized using the minimum, maximum, measures of central tendency such as the mean and median \& measures of dispersion such as the standard deviation (SD). Qualitative variables will be summarized in the form of counts and percentages.
For each parameter, a graphical representation of the means ±95% Confidence Interval (CI) will be produced to visually assess the evolution across time, by treatment group.
- Conditions
- Aging
- Being tested
- Tested product group, Control group
- Keywords
- skin aging, Anthelios UVMUNE 400 Oil Control Fluid SPF 50+, preventive effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tested product groupOther
Apply the test product per zone at least twice a day on the face, neck (neck \& nape), décolleté and back of the hand in the morning and at midday whatever the weather conditions and the activities of the day
Control groupOther
Maintain their normal routine of using cosmetics (cleansers and moisturizers) and normal sun protection habits (if applicable)
| Study group | Role | What they receive |
|---|---|---|
| Tested product group | Experimental | Volunteers using the investigational product handed over to them Receives: Other: Tested product group |
| Control group | Active comparator | Volunteers using their own sun protection routine Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the dermatological assessment of skin signs on the face (Global score)
Assessment of the skin parameters: Skin roughness [absent (0), mild (2), moderate (4), severe (6)]; Skin laxity [absent (0), mild (2), moderate (4), severe (6)]; Skin suppleness [high(0), moderate (2),low (4), absent (6)]; Skin radiance [highly radiant (0), radiant (2), normal(4), dull(6), highly dull(8)]; Pigmented spots [absent (0), visible (2), highly visible (4)]; Skin tone homogeneity [homogeneous (0), non-homogeneous (2)].
Measured: Day0; Day84; Day168; Day252; Day336
Secondary outcomes (1)
Dermatological assessment of skin signs on the face - Atlas Bazin, Flament (Global score)
Assessment of the skin parameters: Forehead wrinkles (0 - 5); Crow feet wrinkles number (1 - 4); Crow feet wrinkles deepness (1 - 6); Glabellar wrinkles (0 - 5); Glabellar fine lines (0 - 5); Underneath eye wrinkle (0 - 5); Corner mouth wrinkle (0 - 6); Nasolabial fold (0 - 5); Upper lip wrinkles (0 - 6); Neck fold (0 - 5); Neck sagging (0 - 5); Ptosis (0 - 5); Eye bags (0 - 5
Measured: Day0; Day84; Day168; Day252; Day336
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start3 Apr 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renato Moura, Principal investigator, Centre International de Développement Pharmaceutique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697288
- Sponsor's protocol ID
- LRP23007-2223CBCL064 Anthelios
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the UVMune 400 Fluid Sunscreen on the Face Versus Usual Photoprotection Routine on Visible and Measurable Signs of Aging
- ClinicalTrials.gov ID
- NCT06697288
- Acronym / sponsor ID
- LRP23007-2223CBCL064 Anthelios
- Conditions
- Aging
- Keywords
- skin aging, Anthelios UVMUNE 400 Oil Control Fluid SPF 50+, preventive effect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 20 Nov 2024 (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.
This experimental, randomized study aims at evaluating the preventative effect of a Sun Protection Factor (SPF) 50+ sunscreen (Anthelios UVMUNE 400 Fluid SPF 50+) with high Ultraviolet A (UVA) protection on clinical signs of skin aging.
Detailed description
The study will be conducted in compliance with the protocol, current internal procedures and in the spirit of the International Council on Harmonisation (ICH) Topic E6(R2)5 ref: EMA/CHMP/ICH/135/1995, ICH Good Clinical Practice (GCP) Addendum Nov 2016 and applicable regulatory requirement.
Statistical plan: Tx represents the values observed at Time x, for each parameter and by subgroup. Quantitative variables, or those that can reasonably be treated as such, will be summarized using the minimum, maximum, measures of central tendency such as the mean and median \& measures of dispersion such as the standard deviation (SD). Qualitative variables will be summarized in the form of counts and percentages.
For each parameter, a graphical representation of the means ±95% Confidence Interval (CI) will be produced to visually assess the evolution across time, by treatment group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tested product group | Experimental | Other: Tested product groupVolunteers using the investigational product handed over to them |
| Control group | Active comparator | Other: Control groupVolunteers using their own sun protection routine |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects with signs of photo aging (Global score of at least 14)
- All skin types
Key exclusion criteria (3 listed)
- Any history of significant dermatological/ophthalmological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site
- Pregnant or breastfeeding women
- Subject with known allergy to cosmetic products or to any ingredient of the sunscreen product
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 |
|---|---|---|
| Tested product groupApply the test product per zone at least twice a day on the face, neck (neck \& nape), décolleté and back of the hand in the morning and at midday whatever the weather conditions and the activities of the day | Other | Tested product group |
| Control groupMaintain their normal routine of using cosmetics (cleansers and moisturizers) and normal sun protection habits (if applicable) | Other | Control group |
Primary outcome
Change in the dermatological assessment of skin signs on the face (Global score)
Time frame: Day0; Day84; Day168; Day252; Day336
Assessment of the skin parameters: Skin roughness [absent (0), mild (2), moderate (4), severe (6)]; Skin laxity [absent (0), mild (2), moderate (4), severe (6)]; Skin suppleness [high(0), moderate (2),low (4), absent (6)]; Skin radiance [highly radiant (0), radiant (2), normal(4), dull(6), highly dull(8)]; Pigmented spots [absent (0), visible (2), highly visible (4)]; Skin tone homogeneity [homogeneous (0), non-homogeneous (2)].
1 secondary outcome
Dermatological assessment of skin signs on the face - Atlas Bazin, Flament (Global score)
Time frame: Day0; Day84; Day168; Day252; Day336
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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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.
Renato Moura principal investigator
Centre International de Développement Pharmaceutique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tested product group in people with 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renato Moura ((55) 21 2221 6180, renato.moura.b@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the dermatological assessment of skin signs on the face (Global score) (time frame: Day0; Day84; Day168; Day252; Day336). 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 20 Nov 2024.