Healthy Female VolunteerNCT07431203
Relationship Between Skin Microbiome, Epigenetic Age, and Facial Features in Aging
An observational study of Healthy Female Volunteer, run by Lesaffre International at 1 site in France.
Trial summary
The goal of this observational study is to evaluate the effect of age on skin microbiome. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Female Volunteer
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2025to 11 Dec 2025
- Phase
- Observational
- 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population to be studied will be women between 25 to 35 years old and between 55 to 65 years old in order to evaluate the relationship between skin collection and saliva sampling and skin measurements.
Who may be able to join
- Healthy subject;
- Sex: female
- Age: 50% having between 25 to 35 years old or 50% between 55 to 65 years old
- Type: Caucasian
- Phototype: I to III on the Fitzpatrick scale
- Subject, having given freely and expressly her informed consent.
Show all 10Show fewer
- Subject, psychologically able to understand the study related information and to give a written informed consent;
- Subject able to comply with protocol requirements;
- Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study.
- Women between 55 to 65 years old should be menopausal (last menstrual period at least 12 months before the screening visit
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the study;
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
- Subject who is under guardianship or who is not able to express her consent;
- Subject in a social or sanitary establishment;
- Subject suspected to be non-compliant according to the investigator's judgment;
- Subject having received 6000 euros indemnities for participation in a clinical research in the 12 previous months, including participation in the present study;
Show all 29Show fewer
- Subject enrolled in another clinical trial or which exclusion period is not over.
- Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk or which may interfere with the evaluation;
- Subject suffering from a severe or progressive disease.
- Subject with current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the face that could interfere with the evaluation.
- Subject with a tattoo, a scar, moles, acne, too many hairs or anything on the studied zones which might interfere with the evaluation.
- Subject having received injection on the face with botulinum toxin in the year before the screening.
- Subject having received injection of filling product on the face in the year before the screening visit.
- Subject having received injection of mesotherapy in the face in the past 6 months before the screening visit.
- Subject having done a superficial or medium peeling or a superficial scrub on the face within the 2 previous months.
- Subject having received tensor threads on the face in the two years before the screening visit.
- Subject having received treatment with a laser, ultrasound or radiofrequency treatment, a dermabrasion, a surgery, a chemical peeling or any other procedure based on active dermal response on the face within the past 6 months.
- Subject having used LED mask in the three weeks before screening visit
- Subject undergoing a topical treatment on the face or a systemic treatment:
- anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study;
- corticosteroids during the 2 previous weeks and during the study;
- retinoids, anti-acne treatment and/or immunosuppressors during the 3 previous months and during the study;
- any medication stabilized for less than one month.
- Subject having started or changed her oral contraceptive treatment during the three previous months.
- Subject under oral hormonal substitutive treatment during the year previous the screening visit
- Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study;
- Subject having changed her life habits within the previous month and/or during the study;
- Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).
- Subject having started or changed her face care products and or make-up within the previous month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial Investigating the Relationship Between Skin Microbiome, Epigenetic Biological Age and Facial Morphological Features in Aging Context
The goal of this observational study is to evaluate the effect of age on skin microbiome.
- Conditions
- Healthy Female Volunteer
- Keywords
- microbiome, skin, epigenetic, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| young | between 25 to 35 years old | |
| old | between 55 to 65 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin microbiome
Measured: single time point
Secondary outcomes (2)
skin face measurement
Measured: single time point
Epigenetic biological age
Measured: single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start13 Oct 2025
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Female VolunteerStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lesaffre International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431203
- Sponsor's protocol ID
- 2025-A01505-44
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Investigating the Relationship Between Skin Microbiome, Epigenetic Biological Age and Facial Morphological Features in Aging Context
- ClinicalTrials.gov ID
- NCT07431203
- Acronym / sponsor ID
- 2025-A01505-44
- Conditions
- Healthy Female Volunteer
- Keywords
- microbiome, skin, epigenetic, aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lesaffre InternationalIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 24 Feb 2026 (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 goal of this observational study is to evaluate the effect of age on skin microbiome.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| young | – | –between 25 to 35 years old |
| old | – | –between 55 to 65 years old |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population to be studied will be women between 25 to 35 years old and between 55 to 65 years old in order to evaluate the relationship between skin collection and saliva sampling and skin measurements.
Key inclusion criteria (10 listed)
- Healthy subject;
- Sex: female
- Age: 50% having between 25 to 35 years old or 50% between 55 to 65 years old
- Type: Caucasian
- Phototype: I to III on the Fitzpatrick scale
Key exclusion criteria (29 listed)
- Pregnant or nursing woman or planning a pregnancy during the study;
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
- Subject who is under guardianship or who is not able to express her consent;
- Subject in a social or sanitary establishment;
- Subject suspected to be non-compliant according to the investigator's judgment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin microbiome
Time frame: single time point
2 secondary outcomes
skin face measurement
Time frame: single time point
Epigenetic biological age
Time frame: single time point
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 24 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Female Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of KM04 Compared to United States (US)-Gonal-f Revised Formulation Female (RFF) Redi-ject and European Union (EU)-Gonal-f in Healthy Adult Female Volunteers
Healthy Female Adult Volunteers
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
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?
An observational study of Healthy Female Volunteer, run by Lesaffre International at 1 site in France.
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 29 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 24 Feb 2026. 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 France. 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?
Skin microbiome (time frame: single time point). 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 24 Feb 2026.