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

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ClinicalTrials.gov Identifier: NCT03465150
Recruitment Status : Not yet recruiting
First Posted : March 14, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment
Acne Other: acne

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).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital: the COPACNE Cohort.
Estimated Study Start Date : March 30, 2018
Estimated Primary Completion Date : February 28, 2033
Estimated Study Completion Date : December 28, 2033

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: acne
    Patient with acne
    Other Name: acne vulgaris


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. 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.

  3. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients going for the first time in specialized consultation "acne"
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465150


Contacts
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Contact: Brigitte DRENO 0240083137 brigitte.dreno@wanadoo.fr
Contact: Amir khammari amir.khammari@chu-nantes.fr

Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Brigitte DRENO, PU-PH CHU de Nantes

Additional Information:

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03465150     History of Changes
Other Study ID Numbers: RC17_0218
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Acne
Cohort
prospective
risk factors
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases