Status:
COMPLETED
Acne Vulgaris Related Microbiology and Serology
Lead Sponsor:
Sanofi
Collaborating Sponsors:
CRAT
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18-40 years
Brief Summary
This will be an investigation to determine the quality of the serological immune responses against Propionibacterium acnes (P. acnes) in acne patients compared to healthy individuals. In particular, t...
Detailed Description
Acne vulgaris, which affects \>85% of teenagers and \>10% of adults, was recently re-defined as a complex chronic disease associated with Propionibacterium acnes (P. acnes). Until recently, the pathog...
Eligibility Criteria
Inclusion
- Acne patients (18 - 40 years of age)
- Clinical diagnosis of medium acne vulgaris (covering more than 30% of the patient's face and loaded with comedones, pustules and acne lesions of \>2 cm in size) for at least six months or longer
- Clinical diagnosis of severe acne vulgaris (acne conglobata, sinus or cystic type acne covering most of the face (\>60% of the facial surface) - IGA 3-4) for at least six months or longer
- Age-matched healthy adults (between 18 and 40 years), with history of moderate or severe acne, but who have been free from acne for more than two years - 'free from acne' period may include minor, intermittent breakouts due to hormonal reasons, such as menstruation
Exclusion
- Subjects who received anti-acne antibiotic therapy less than 2 months prior to recruitment
- Subjects who received isotretinoin therapy within the last 6 months
- Subjects who were using hormonal contraceptives within the last 3 months
Key Trial Info
Start Date :
January 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04056598
Start Date
January 18 2018
End Date
September 30 2019
Last Update
January 6 2021
Active Locations (1)
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1
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507