NCT02204254

RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rosacea

Interventions

Type	Name	Description
DEVICE	Radiofrequence	Associated to arm radiofrequence
DRUG	Doxycycline	doxycycline 100 mg / day for 3 months with clinical evaluation, photos, and confocal SSSB V1 and V4 (M6). Tour V2 M1 for clinical evaluation of safety review, collection of adverse events and issuing end of treatment. Visit V3 M3 on adverse effects.

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-04-01
• Completion: 2021-06-07
• First posted: 2014-07-30
• Last updated: 2022-06-01

Locations

1 site across 1 country: France