RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea

Condition(s) targeted: Rosacea

Intervention: Radiofrequence (Device); Doxycycline (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Centre Hospitalier Universitaire de Nice

Official(s) and/or principal investigator(s):
Le Duff Florence, Ph, Principal Investigator, Affiliation: CRC, Hôpital Archet, 151 route de saint-antoine de ginestière 06200 Nice

Overall contact:
LE DUFF Florence, Ph, Phone: +33492036070, Email: leduff.f2@chu-nice.fr

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.

Official title: Prospective, Open Label, Randomized Study Comparing Bipolar Radiofrequency Potentiated by Infrared Light to Doxycycline in Patient With Papulopustular Rosacea

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome: scorecard score

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

LE DUFF Florence, Ph, Phone: +33492036070, Email: leduff.f2@chu-nice.fr

CRC, Hôpital de l'Archet, 151 route de saint-ginestière, Nice, Alpes-maritimes 06200, France; Recruiting
LE DUFF Florence, Ph, Phone: +33492036070, Email: leduff.f2@chu-nice.fr
Garcia Lauriane, Email: garcia.l@chu-nice.fr
LE DUFF Florence, Ph, Principal Investigator

Starting date: March 2014
Last updated: July 29, 2014