AcneCOPACNENCT03465150
Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital
An observational study of Acne, run by Nantes University Hospital at 1 site in France.
Trial summary
With 24 million results associated with Google's searchon keywords "severe acne", Pr Dreno's team understand better thatthis disease, which affects many French people, is a real concern of Public Health and not a "forced evil" of the adolescent period, which will eventually resolve itself. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acne
- What is being tested?
- acne
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2018to 28 Dec 2033
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients going for the first time in specialized consultation "acne"
Who may be able to join
- Patient with acne
- Patient (or parents/guardians for minors) who are not opposed to participating in the cohort.
- Subjects affiliated to an appropriate health insurance
Who cannot join
- Dermatosis of the face other than acne
- Refusal to participate by the minor or parent/guardian
- Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amir khammari contact
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44000
Brigitte Dreno, PU-PH, brigitte.dreno@chu-nantes.fr
About this study
Official title: Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital: the COPACNE Cohort.
With 24 million results associated with Google's searchon keywords "severe acne", Pr Dreno's team understand better thatthis disease, which affects many French people, is a real concern of Public Health and not a "forced evil" of the adolescent period, which will eventually resolve itself. Acne does not affect the vital prognosis, but its psychosocial impact is major and should not be underestimated. Paradoxically, despite the high prevalence of acne, few quality epidemiological studies have been published. Physicians are often helpless when faced with patients' questions. They often need a lot of explanations, especially on the factors aggravating this dermatosis, which greatly affects their quality of life.
This cohort, the first of its kind in France, will determine the predictive factors of therapeutic response, endogenous and environmental factors impacting on the severity of acne assess the quality of life and psychological impact of acne patients, determine the patient's course of care and the associated costs. Pr Dreno's team will also build up a bio collection (bacteriological samples).
Read the detailed description
All patients going for the first time in specialized consultation "acne" at Nantes University Hospital , and who meet the inclusion criteria will be included in the COPACNE cohort. Inclusion will take place at the first consultation, after information and agreement of the patient and, if applicable, his or her legal representatives. The frequency of each patient's follow-up visits will be determined on a case-by-case basis according to the patient's medical needs (generally, the interval between 2 visits is between 1 and 4 months).
- Conditions
- Acne
- Being tested
- acne
- Keywords
- Acne, Cohort, prospective, risk factors
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acneOther
Also called acne vulgaris
Patient with acne
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Acne stage
composite criteria. the scale is GEA for Global Evaluation Acne Scale with 0 no acne to 5 severe acne
Measured: 2 years
Secondary outcomes (3)
assessing patients' quality of life
composite criteria. CADI score is calculated by summing the score of each question resulting in a possible maximum of 15 and a minimum of 0. The higher the score, the more the quality of life is impaired.
Measured: 2 years
cost of acne illness
reimbursement data relating to hospitalizations and care in town recorded by the Health Insurance in the SNIIRAM database.
Measured: 2 years
Bacteriological sample to find Propionibacterium acnes, Hormonal check-up on blood sample
Correlation between bacterial and blood samples and the efficacity of the treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start23 Sep 2018
- Primary completion28 Feb 2033 (estimated)
- Study completion28 Dec 2033 (estimated)
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.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte DRENO, PU-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465150
- Sponsor's protocol ID
- RC17_0218
- Acronym
- COPACNE
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2018
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital: the COPACNE Cohort.
- ClinicalTrials.gov ID
- NCT03465150
- Acronym / sponsor ID
- COPACNE / RC17_0218
- Conditions
- Acne
- Keywords
- Acne, Cohort, prospective, risk factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 23 Sep 2018 (actual)
- Primary completion
- 28 Feb 2033 (estimated)
- Study completion
- 28 Dec 2033 (estimated)
- First posted
- 14 Mar 2018 (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.
With 24 million results associated with Google's searchon keywords "severe acne", Pr Dreno's team understand better thatthis disease, which affects many French people, is a real concern of Public Health and not a "forced evil" of the adolescent period, which will eventually resolve itself. Acne does not affect the vital prognosis, but its psychosocial impact is major and should not be underestimated. Paradoxically, despite the high prevalence of acne, few quality epidemiological studies have been published. Physicians are often helpless when faced with patients' questions. They often need a lot of explanations, especially on the factors aggravating this dermatosis, which greatly affects their quality of life.
This cohort, the first of its kind in France, will determine the predictive factors of therapeutic response, endogenous and environmental factors impacting on the severity of acne assess the quality of life and psychological impact of acne patients, determine the patient's course of care and the associated costs. Pr Dreno's team will also build up a bio collection (bacteriological samples).
Detailed description
All patients going for the first time in specialized consultation "acne" at Nantes University Hospital , and who meet the inclusion criteria will be included in the COPACNE cohort. Inclusion will take place at the first consultation, after information and agreement of the patient and, if applicable, his or her legal representatives. The frequency of each patient's follow-up visits will be determined on a case-by-case basis according to the patient's medical needs (generally, the interval between 2 visits is between 1 and 4 months).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients going for the first time in specialized consultation "acne"
Key inclusion criteria (3 listed)
- Patient with acne
- Patient (or parents/guardians for minors) who are not opposed to participating in the cohort.
- Subjects affiliated to an appropriate health insurance
Key exclusion criteria (3 listed)
- Dermatosis of the face other than acne
- Refusal to participate by the minor or parent/guardian
- Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard)
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 |
|---|---|---|
| acneAlso: acne vulgarisPatient with acne | Other | – |
Primary outcome
Measure of Acne stage
Time frame: 2 years
composite criteria. the scale is GEA for Global Evaluation Acne Scale with 0 no acne to 5 severe acne
3 secondary outcomes
assessing patients' quality of life
Time frame: 2 years
cost of acne illness
Time frame: 2 years
Bacteriological sample to find Propionibacterium acnes, Hormonal check-up on blood sample
Time frame: 2 years
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 13 Apr 2026.
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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.
Amir khammari contact
Brigitte DRENO, PU-PH principal investigator
Nantes University Hospital
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 Acne, run by Nantes University Hospital 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 3 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 13 Apr 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?
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 Brigitte DRENO (0240083137, brigitte.dreno@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Acne stage (time frame: 2 years). 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 13 Apr 2026.