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

September 10, 2021 updated by: Nantes University Hospital

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients going for the first time in specialized consultation "acne"

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Brigitte DRENO, PU-PH, CHU de Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 23, 2018

Primary Completion (ANTICIPATED)

February 28, 2033

Study Completion (ANTICIPATED)

December 28, 2033

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

March 7, 2018

First Posted (ACTUAL)

March 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC17_0218

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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