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Completed

NCT Number: NCT02204254

RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea

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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Nice, Alpes-maritimes, 06200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequence

Device

Associated to arm radiofrequence

Doxycycline

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.

Primary outcomes

  1. 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)

    Time frame: at 6 months

    The primary endpoint is the 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) evaluated on photographs by an independent investigator.

    Inflammatory lesions are considered for the evaluation of PGA because it is not expected that the compared treatments improve erythema and telangectasia.

Secondary outcomes

  1. scorecard score

    Time frame: at 6 months

    a) inflammatory lesions count will be assessed on the cheeks. The rate of lesions reduced is the ratio: b ) other symptoms will be achieved by the assessment of erythema (0-3 ) and telangiectasia (score 0-3 ) in the scorecard score.

    c ) The patient satisfaction will be assessed by a Visual Analogue Scale (VAS) .

    d) The evaluation of the density of demodex will be assessed on the skin surface biopsy ( SSSB ) and by confocal microscopy ( MCIV ) e ) The skin temperature during radiofrequency sessions will be reported by infrared thermometer skin temperature during the treatment session RF

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: Rosac-RF

Important dates

Study start
2014
Primary completion
2018
Study completion
2021
First posted
Jul 30, 2014
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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