RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea

NCT ID: NCT02204254

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2021-06-07

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.

Conditions

Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiofrequence

3 sessions of radiofrequency at 3 weeks intervals V1, V2 (W3 or W4) and V3 (between W6 and W8), with clinical examination, evaluation of tolerance, adverse events report, photos, surface biopsy (SSSB), and confocal microscopy (V1 and V3). Follow up visit V4 (M6) with clinical evaluation, photos, SSSB, confocal microscopy, adverse events report and treatment satisfaction.

Group Type: EXPERIMENTAL

Radiofrequence

Intervention Type: DEVICE

Associated to arm radiofrequence

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.

Group Type: PLACEBO_COMPARATOR

Doxycycline

Intervention Type: DRUG

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.

Interventions

Radiofrequence

Associated to arm radiofrequence

Intervention Type: DEVICE

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Le Duff Florence, Ph

Role: PRINCIPAL_INVESTIGATOR

CRC, Hôpital Archet, 151 route de saint-antoine de ginestière 06200 Nice

Locations

CRC, Hôpital de l'Archet, 151 route de saint-ginestière

Nice, Alpes-maritimes, France

Countries

France

Other Identifiers

13-AOI-13

Identifier Type: -

Identifier Source: org_study_id