RosaceaRosac-RFNCT02204254
RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea
A study testing Radiofrequence and Doxycycline in people with Rosacea, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rosacea
- What is being tested?
- Radiofrequence and Doxycycline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to 7 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Subject carrying cochlear implants or open wound or in the process of healing
- Minor patient or under tutorship
- Cyanoacrylate or doxycycline allergy
Trial locations and contacts
1 site in 1 country.
France1 site
CRC, Hôpital de l'Archet, 151 route de saint-ginestière
Nice, Alpes-maritimes, 06200
About this study
Official title: Prospective, Open Label, Randomized Study Comparing Bipolar Radiofrequency Potentiated by Infrared Light to Doxycycline in Patient With Papulopustular 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.
- Conditions
- Rosacea
- Being tested
- Radiofrequence, Doxycycline
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequenceDevice
Associated to arm radiofrequence
DoxycyclineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 6 months
Secondary outcomes (1)
scorecard score
- 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) .
- 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
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2018
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Le Duff Florence, Ph, Principal investigator, CRC, Hôpital Archet, 151 route de saint-antoine de ginestière 06200 Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204254
- Sponsor's protocol ID
- 13-AOI-13
- Acronym
- Rosac-RF
- Status last verified
- May 2022
- First submitted
- 7 Mar 2014
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Label, Randomized Study Comparing Bipolar Radiofrequency Potentiated by Infrared Light to Doxycycline in Patient With Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT02204254
- Acronym / sponsor ID
- Rosac-RF / 13-AOI-13
- Conditions
- Rosacea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequence | Experimental | Device: Radiofrequence3 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 | Placebo comparator | Drug: Doxycyclinedoxycycline 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiofrequenceAssociated to arm radiofrequence | Device | Radiofrequence |
| Doxycyclinedoxycycline 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 |
Primary outcome
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.
1 secondary outcome
scorecard score
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Le Duff Florence, Ph principal investigator
CRC, Hôpital Archet, 151 route de saint-antoine de ginestière 06200 Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequence and Doxycycline in people with Rosacea, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022; AzTrials last refreshed its copy on 26 Oct 2026.