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

Acne Clinical Trial

— COPACNE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03465150
• Other study ID #: RC17_0218
• Status: Recruiting
• Start date: September 23, 2018
• Est. completion date: December 28, 2033

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: Brigitte DRENO
• Phone: 0240083137
• Email: brigitte.dreno[@]wanadoo.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 28, 2033
• Est. primary completion date: February 28, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Other:
• acne
Patient with acne

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Acne stage	composite criteria. the scale is GEA for Global Evaluation Acne Scale with 0 no acne to 5 severe acne	2 years
Secondary	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.	2 years
Secondary	cost of acne illness	reimbursement data relating to hospitalizations and care in town recorded by the Health Insurance in the SNIIRAM database.	2 years
Secondary	Bacteriological sample to find Propionibacterium acnes, Hormonal check-up on blood sample	Correlation between bacterial and blood samples and the efficacity of the treatment	2 years