AcneNCT06841393
Assessment of Biological, Biometrological Parameters and Consumer Needs in Adult Subjects with Acne
A study testing Biometrological measurements, Biological sampling and Clinical assessments in people with Acne and Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
Acne vulgaris (acne) is a chronic inflammatory pathology of the pilosebaceous unit. Its prevalence is about 85% of teenagers and is constantly increasing in adults, especially women. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- What is being tested?
- Biometrological measurements, Biological sampling and Clinical assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2023to 17 Jan 2024
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Inlcusion criteria:
Criteria related to the population:
- Subject aged between 18 and 30 years included
- For women of childbearing potential: use of an effective method of contraception, as assessed by the investigator, introduced and unchanged for at least 3 months before inclusion in the study
Criteria related to diseases:
Specific for acne group:
- Subject with acne lesions on the face, with a Global Acne Evaluation (GEA) score evaluated on the face of 2 (mild) or 3 (moderate) assessed by the investigator on a 5-point scale (0, 1, 2, 3, 4, 5 with 0 = clear - no lesions and 5 = very severe)
Non-inclusion criteria:
Criteria related to the population:
- For women of childbearing potential: pregnant or breastfeeding
- Subject having received on face artificial UV exposure, excessive or prolonged exposure to natural sunlight within 4 weeks before the inclusion visit
- Subject with facial hair liable to interfere with the study assessments
Criteria related to the disease:
- Clinical signs of hormone dysfunction or hyperandrogenism
- Severe form of acne (acne conglobata, acne fulminans or nodulocystic acne) or acneiform eruptions, in the investigator's opinion
- Sunburn on the face due to excessive UV exposure
Criteria related to skin condition:
- Subject having any other dermatologic condition than acne, or characteristics (like tattoo) on the face liable to interfere with the study assessments
Specific for control group:
- Subject with significant acne lesions according to investigator assessment
- Subject having any inflammatory face dermatosis
Criteria related to treatments and/or products:
- Any surgery, chemical or physical treatment on the face in the 12 months before the inclusion visit
- Systemic isotretinoin treatment taken in the 6 months prior before the inclusion visit
- Systemic acne treatment taken in the 3 months before the inclusion visit
- Probiotics taken orally in the month before the inclusion visit
- Topical acne treatment applied to the face in the month before the inclusion visit
- Topical or Systemic Non-Steroidal Anti-Inflammatory (NSAI), corticosteroids, taken or applied to the face in the 2 weeks before the inclusion visit
- Skincare product for acne liable to interfere with the study according to investigator's assessment applied to the face in the 2 weeks before the inclusion visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knowledge and Exploratory Study to Better Understand Face Acne Pathophysiology and Acne Lesion Severity by Multi-omic Approaches, Biometrological Analysis and Consumer Needs
Acne vulgaris (acne) is a chronic inflammatory pathology of the pilosebaceous unit. Its prevalence is about 85% of teenagers and is constantly increasing in adults, especially women. Acne is a multifactorial disease involving abnormalities in follicular keratinization, sebum production, skin microbiota and inflammation.
The early stage of acne is characterized by the presence of primary retentional lesions: the open comedones (or blackheads) and closed comedones (or whitehead). These retentional lesions can progress to highly inflammatory lesions: superficial inflammatory lesions (papules and pustules) and in some cases in deep inflammatory lesions (nodules). Finally, acne lesions can lead to the development of superficial post inflammatory erythema or hyperpigmentation, resulting in emotional distress and a poorer quality of life.
Read more
Currently, a better understanding of the switch from healthy to acne-prone skin, but also of the transition from retentional lesions to more severe inflammatory lesions, seems essential to propose adapted and specific treatments.
The aim of this study is to better understand acne pathophysiology of the face by a multi-omic approaches, biometrological analysis and consumer needs collection to bring information, in the same study on the local ecosystem of non-lesional areas, retentional lesional areas and inflammatory lesional areas of adult acne prone skin, compared to acne free face.
- Being tested
- Biometrological measurements, Biological sampling, Clinical assessments, Questionnaire
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biometrological measurementsOther
Measurements will be taken from the face:
- For acne group: inflammatory lesional area and non-lesional area
- For control group: non-lesional area
Biological samplingOther
Samples will be taken from the face:
- For acne group: inflammatory lesional area, non-lesional area and retentional area
- For control group: non-lesional area
Clinical assessmentsOther
Only for acne group: acne scores will be evaluated on the face by the investigator
QuestionnaireOther
Only for acne group: consumers' perception
| Study group | Role | What they receive |
|---|---|---|
| Control subject group | Other | Not described Receives: Other: Biometrological measurements; Other: Biological sampling |
| Subject group with mild to moderate acne on the face | Other | Not described Receives: Other: Biometrological measurements; Other: Biological sampling; Other: Clinical assessments; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous pH measurement
by pH - pHmeter
Measured: baseline (Visit 1- Day 1)
Sebum quantification
by Lipidic Index (LI) - Sebumeter®
Measured: baseline (Visit 1- Day 1)
Cutaneous barrier integrity
by Trans-Epidermal Water Loss (TEWL) - Aquaflux®
Measured: baseline (Visit 1- Day 1)
Epigenetic analysis by sampling method (urine)
Measured: baseline (Visit 1- Day 1)
Microbiota profile by sampling method (swabs)
By non-targeting metagenomics
Measured: baseline (Visit 1- Day 1)
Microbiota profile by sampling method (extracted comedones)
for acne group only
Measured: baseline (Visit 1- Day 1)
Metabolomic profile by sampling method (swabs)
By metabolomic analysis
Measured: baseline (Visit 1- Day 1)
Metabolomic profile by sampling method (extracted comedones)
for acne group only
Measured: baseline (Visit 1- Day 1)
Lipidomic profile by mass spectroscopy (in-vivo measurements)
Each characteristic peak corresponding to specific lipid will be quantified by its mass intensity
Measured: baseline (Visit 1- Day 1)
Lipidomic profile by sampling method (scotch)
By lipidomic analysis
Measured: baseline (Visit 1- Day 1)
Lipidomic profile by sampling method (extracted comedones)
for acne group only
Measured: baseline (Visit 1- Day 1)
Acne severity on the face
using Global Acne Evaluation (GEA) scale on a 6-point scale (0, 1, 2, 3, 4, 5 with 0 = clear - no lesions and 5 = very severe) in acne group only
Measured: baseline (Visit 1- Day 1)
Lesions quantification
by the number of inflammatory lesions (papules and/or pustules) in acne group
Measured: baseline (Visit 1- Day 1)
Consumers' perception
by a questionnaire about acne skin, skincare routine, needs and expectations in terms of facial care in acne group
Measured: baseline (Visit 1- Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start16 Oct 2023
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841393
- Sponsor's protocol ID
- INTERACNE
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 24 Feb 2025
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Exploratory Study to Better Understand Face Acne Pathophysiology and Acne Lesion Severity by Multi-omic Approaches, Biometrological Analysis and Consumer Needs
- ClinicalTrials.gov ID
- NCT06841393
- Acronym / sponsor ID
- INTERACNE
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 24 Feb 2025 (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.
Acne vulgaris (acne) is a chronic inflammatory pathology of the pilosebaceous unit. Its prevalence is about 85% of teenagers and is constantly increasing in adults, especially women. Acne is a multifactorial disease involving abnormalities in follicular keratinization, sebum production, skin microbiota and inflammation.
The early stage of acne is characterized by the presence of primary retentional lesions: the open comedones (or blackheads) and closed comedones (or whitehead). These retentional lesions can progress to highly inflammatory lesions: superficial inflammatory lesions (papules and pustules) and in some cases in deep inflammatory lesions (nodules). Finally, acne lesions can lead to the development of superficial post inflammatory erythema or hyperpigmentation, resulting in emotional distress and a poorer quality of life.
Currently, a better understanding of the switch from healthy to acne-prone skin, but also of the transition from retentional lesions to more severe inflammatory lesions, seems essential to propose adapted and specific treatments.
The aim of this study is to better understand acne pathophysiology of the face by a multi-omic approaches, biometrological analysis and consumer needs collection to bring information, in the same study on the local ecosystem of non-lesional areas, retentional lesional areas and inflammatory lesional areas of adult acne prone skin, compared to acne free face.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control subject group | Other | Other: Biometrological measurements, Other: Biological sampling |
| Subject group with mild to moderate acne on the face | Other | Other: Biometrological measurements, Other: Biological sampling, Other: Clinical assessments, Other: Questionnaire |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Biometrological measurementsMeasurements will be taken from the face: * For acne group: inflammatory lesional area and non-lesional area * For control group: non-lesional area | Other | Control subject group, Subject group with mild to moderate acne on the face |
| Biological samplingSamples will be taken from the face: * For acne group: inflammatory lesional area, non-lesional area and retentional area * For control group: non-lesional area | Other | Control subject group, Subject group with mild to moderate acne on the face |
| Clinical assessmentsOnly for acne group: acne scores will be evaluated on the face by the investigator | Other | Subject group with mild to moderate acne on the face |
| QuestionnaireOnly for acne group: consumers' perception | Other | Subject group with mild to moderate acne on the face |
Primary outcome
Cutaneous pH measurement
Time frame: baseline (Visit 1- Day 1)
by pH - pHmeter
Sebum quantification
Time frame: baseline (Visit 1- Day 1)
by Lipidic Index (LI) - Sebumeter®
Cutaneous barrier integrity
Time frame: baseline (Visit 1- Day 1)
by Trans-Epidermal Water Loss (TEWL) - Aquaflux®
Epigenetic analysis by sampling method (urine)
Time frame: baseline (Visit 1- Day 1)
Microbiota profile by sampling method (swabs)
Time frame: baseline (Visit 1- Day 1)
By non-targeting metagenomics
Microbiota profile by sampling method (extracted comedones)
Time frame: baseline (Visit 1- Day 1)
for acne group only
Metabolomic profile by sampling method (swabs)
Time frame: baseline (Visit 1- Day 1)
By metabolomic analysis
Metabolomic profile by sampling method (extracted comedones)
Time frame: baseline (Visit 1- Day 1)
for acne group only
Lipidomic profile by mass spectroscopy (in-vivo measurements)
Time frame: baseline (Visit 1- Day 1)
Each characteristic peak corresponding to specific lipid will be quantified by its mass intensity
Lipidomic profile by sampling method (scotch)
Time frame: baseline (Visit 1- Day 1)
By lipidomic analysis
Lipidomic profile by sampling method (extracted comedones)
Time frame: baseline (Visit 1- Day 1)
for acne group only
Acne severity on the face
Time frame: baseline (Visit 1- Day 1)
using Global Acne Evaluation (GEA) scale on a 6-point scale (0, 1, 2, 3, 4, 5 with 0 = clear - no lesions and 5 = very severe) in acne group only
Lesions quantification
Time frame: baseline (Visit 1- Day 1)
by the number of inflammatory lesions (papules and/or pustules) in acne group
Consumers' perception
Time frame: baseline (Visit 1- Day 1)
by a questionnaire about acne skin, skincare routine, needs and expectations in terms of facial care in acne group
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
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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 Biometrological measurements, Biological sampling and Clinical assessments in people with Acne and Healthy, run by Pierre Fabre Dermo Cosmetique 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?
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: stopped early, as of the sponsor's last update on 24 Feb 2025. 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 was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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?
Cutaneous pH measurement (time frame: baseline (Visit 1- Day 1)). The study lists 14 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 24 Feb 2025.