Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital

Recruiting

• Conditions: Acne

• Registration Number: NCT03465150
• Lead Sponsor: Nantes University Hospital

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-14
• Study Start: 2018-09-23
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-13
• Primary Completion: 2033-02-28
• Study Completion: 2033-12-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure of Acne stage	2 years	composite criteria. the scale is GEA for Global Evaluation Acne Scale with 0 no acne to 5 severe acne

Secondary Outcome Measures

Name	Time	Method
Bacteriological sample to find Propionibacterium acnes, Hormonal check-up on blood sample	2 years	Correlation between bacterial and blood samples and the efficacity of the treatment
assessing patients' quality of life	2 years	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.
cost of acne illness	2 years	reimbursement data relating to hospitalizations and care in town recorded by the Health Insurance in the SNIIRAM database.

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France