Status:
COMPLETED
RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Rosacea
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Rosacea is a chronic facial disfiguring dermatosis characterized by different stages like flushing, erythema, telangiectasia and papulo-pustular lesions. Recommended treatments include topical (metron...
Eligibility Criteria
Inclusion
- Subjects must be between 18-70 years old
- Subjects with papulopustular rosacea graded moderate to severe (2 or 3) according to the physician global Assessment, and with lesions on the cheeks.
- Prior stop of any topical treatment antibiotic, retinoid, corticoid or other topical treatment for rosacea at least 1 month before the start of the study
- Prior stop of any systemic treatment (antibiotic) two month before the start of the study and for isotretinoin at least 6 months
- Last laser treatment, by lamp, laser or LED, at least 3 months before the start of the study
- Subjects must be abble to lie for more than 30 minutes
- Patient able to understand and sign the informed consent form
- Affiliation to a social security scheme
Exclusion
- Women of child bearing/reproductive potential
- Other skin disease or abnormality of the face which could interfere with the evaluation of the different criteria evaluated or with the realization of the RF
- Contraindications to radiofrequency: presence of a defibrillator or pacemaker, dental on the cheeks, dental equipment or metallic orthopedic next to the treated area, skin cancer on the face, progressive systemic disease, uncontrolled hypertension
- Immunosuppression by HIV (determined by examination) or treatment with immunosuppressive
- Tattoos or permanent makeup on the face
- Excessively tanned skin to sunlight, ultraviolet or with tanning creams during the last 2 weeks
- Subject carrying cochlear implants or open wound or in the process of healing
- Minor patient or under tutorship
- Cyanoacrylate or doxycycline allergy
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02204254
Start Date
March 1 2014
End Date
June 7 2021
Last Update
June 1 2022
Active Locations (1)
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1
CRC, Hôpital de l'Archet, 151 route de saint-ginestière
Nice, Alpes-maritimes, France, 06200