Clinical trial NCT03465150: Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital
Official title: Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital: the COPACNE Cohort.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acne
Keywords: Acne
Cohort
prospective
risk factors
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients going for the first time in specialized consultation "acne"

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Measure of Acne stage
timeFrame: 2 years
Secondary outcomes:
measure: assessing patients' quality of life
timeFrame: 2 years
measure: cost of acne illness
timeFrame: 2 years
measure: Bacteriological sample to find Propionibacterium acnes, Hormonal check-up on blood sample
timeFrame: 2 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Brigitte DRENO, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: