Clinical trial NCT02204254: RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea
Official title: Prospective, Open Label, Randomized Study Comparing Bipolar Radiofrequency Potentiated by Infrared Light to Doxycycline in Patient With Papulopustular Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rosacea
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (metronidazole) and systemic (doxycycline) antibiotics with only a suspensive effect. The bipolar radiofrequency (RF) with Elos system (infrared light) is a device emitting an electromagnetic current inducing an increase in temperature when applied on the skin, potentiated by infrared light. The monopolar RF has already been used in rosacea on a small number of cases with positive and prolonged results. RF with Elos system has been evaluated on erythemato-telangiectasic rosacea with encouraging results. Demodex folliculorum (DF) is a long transparent mite which asymptomatically parasitizes pilosebaceous follicle of normal human skin sometimes responsible of inflammatory facial dermatoses. The prevalence and density of DF are increased in rosacea, and DF is suspected to play a role in the pathogenesis of rosacea. DF is sensitive to heat, and the investigators hypothesize that radiofrequency treatment may affect the survival of the mite and should be effective to treat papulopustular rosacea.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: percent of patients with a score of 0 or 1 severity of rosacea (absent or mild) on a scale of 0-3 (Physician Global Assessment)
timeFrame: at 6 months
Secondary outcomes:
measure: scorecard score
timeFrame: at 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CRC, Hôpital de l'Archet, 151 route de saint-ginestière
state: Alpes-maritimes
Study officials:
affiliation: CRC, Hôpital Archet, 151 route de saint-antoine de ginestière 06200 Nice
name: Le Duff Florence, Ph
role: PRINCIPAL_INVESTIGATOR
References: