RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea

NCT02204254 | Completed

• 1 other identifier: 13-AOI-13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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)

  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.

  at 6 months

Secondary Outcomes (1)

• scorecard score

  at 6 months

Study Arms (2)

Radiofrequence

EXPERIMENTAL

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.

Device: Radiofrequence

Doxycycline

PLACEBO COMPARATOR

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.

Drug: Doxycycline

Interventions

Radiofrequence DEVICE

Associated to arm radiofrequence

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.

Doxycycline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

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

Nice, Alpes-maritimes, 06200, France

Location

MeSH Terms

Conditions

Rosacea

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Le Duff Florence, Ph

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: July 30, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: June 7, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

FR (1)