Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03465150
Other study ID # RC17_0218
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05097157 - Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions N/A
Completed NCT05131373 - Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris Phase 1
Completed NCT04806594 - Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar. N/A
Completed NCT02250859 - A Pharmacokinetic Study of Minocycline in Male and Female Volunteers Phase 1
Terminated NCT01193764 - Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris N/A
Completed NCT01206348 - Combination Treatment for Moderate to Severe Acne Phase 4
Completed NCT00725439 - An Open Label Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment Facial Acne Phase 2
Completed NCT05640388 - Assessment of a Cosmetic Product Effect on the Host/Microorganism Relationship in Acneic Subjects
Completed NCT04873089 - Efficacy Study of Cosmetic Product RV3278AET0943 Versus Non-treated Group in Adults With Oily and Acne Prone Skin
Recruiting NCT05941065 - Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin N/A
Recruiting NCT06120452 - A Clinical Trial to Evaluate the Effectiveness of an Acne Serum in Improving Facial Acne and Post-Acne Pigmentation N/A
Completed NCT04300010 - Blue Light Therapy of C. Acnes Phase 4
Recruiting NCT06202274 - Clinical Study to Evaluate the Safety and Efficacy of Candela Technology N/A
Completed NCT04559022 - Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring N/A
Terminated NCT02431494 - Safety and Preliminary Efficacy of Combination Therapy for the Treatment of Acne Vulgaris N/A
Completed NCT05469880 - Efficacy and Tolerance of Formula 609613 37 in Acneic Patients N/A
Completed NCT02944461 - Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris Phase 4
Completed NCT01951417 - Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris Phase 4
Completed NCT01701024 - Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne Phase 3
Completed NCT01245946 - Photodynamic Therapy Compared to Adapalene 0.1% Gel Plus Doxycycline in the Treatment of Acne Vulgaris Phase 2