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RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea (Rosac-RF)

Primary Purpose

Rosacea

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiofrequence
Doxycycline
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Radiofrequence

Doxycycline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

scorecard score
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

Full Information

First Posted
March 7, 2014
Last Updated
May 30, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02204254
Brief Title
RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea
Acronym
Rosac-RF
Official Title
Prospective, Open Label, Randomized Study Comparing Bipolar Radiofrequency Potentiated by Infrared Light to Doxycycline in Patient With Papulopustular Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
June 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequence
Arm Type
Experimental
Arm Description
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.
Arm Title
Doxycycline
Arm Type
Placebo Comparator
Arm Description
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
Device
Intervention Name(s)
Radiofrequence
Intervention Description
Associated to arm radiofrequence
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
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 Outcome Measure Information:
Title
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)
Description
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.
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
scorecard score
Description
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
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Le Duff Florence, Ph
Organizational Affiliation
CRC, Hôpital Archet, 151 route de saint-antoine de ginestière 06200 Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRC, Hôpital de l'Archet, 151 route de saint-ginestière
City
Nice
State/Province
Alpes-maritimes
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

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RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea

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